Datasets

Data from PECARN studies constitute an important scientific resource

To enhance the public health benefit of these studies, public use data sets will be made available to qualified researchers.

PECARN public use data sets are generally made available after study completion in accordance with PECARN policy. PECARN data sets will be provided only to investigators who agree to adhere to the signed research data use agreement.

Execution of a research data use agreement will require approval by investigators’ relevant Institutional Review Boards (IRB) or demonstration of exemption from the need for IRB approval by institutional policy. Data set creation and distribution will be performed by the data coordinating center.

Definitions:

Public Use Data Set:

De-identified data set derived from completed PECARN research protocols.

Research Data Use Agreement:

Agreement between the recipient institution, investigator and the data coordinating center, governing the use of the specific data set.

Procedures:

The data coordinating center will provide the data set, electronic copies of the data worksheets, the final study protocol and a data dictionary. No further support will be provided by the data coordinating center, network investigators, or HRSA, to the recipient investigator.

Investigators will request the use of a specific dataset by choosing the link below, reading and agreeing to the Research Data Use Agreement and providing contact information.

The dataset will be available for download after completion of the aforementioned items.

For further information contact Melissa Laws, BSN, CCRC EMSC Data Center Director at Melissa.laws@hsc.utah.edu

Click on a study below for more information, or to request the dataset.

  • Application of Transcriptional Signatures for Diagnosis of Febrile Infants Within the PECARN Network (TIG)

  • Application of Transcriptional Signatures for Diagnosis of Febrile Infants Within the Pediatric Emergency Care Applied Research Network (PECARN)

  • CT Scan With IV Contrast Alone (CT IV): The Role of Intra-abdominal Fat (IAF) on the Sensitivity of CT IV to Visualize the Normal Appendix (IAF Appendix)

  • Emergency Department Screen for Teens at Risk for Suicide (ED-STARS)

  • Fluid Therapy and Cerebral Injury in Pediatric Diabetic Ketoacidosis (Fluid Therapy in DKA)

  • Hypothermia After Pediatric Cardiac Arrest – Out of Hospital Trial

  • Hypothermia After Pediatric Cardiac Arrest (Planning Grant)

  • Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study.

  • Identifying Children at Very Low Risk of Clinically Important Blunt Abdominal Injuries

  • Impact of Emergency Department Probiotic Treatment of Pediatric Gastroenteritis (Probiotics)

  • Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis (Magnesium in Crisis [MAGIC])

  • Multi-Center Validation of an Implicit Review Instrument to Measure Quality of Care Provided to Children in the Emergency Department

  • PECARN Core Data Project (PCDP) 2002-2014

  • PECARN Core Data Project Ten-Day (2003)

  • PECARN Research Network Registry Project (Registry) 2012-2021 Public Use Dataset (PUD)

  • Predicting Cervical Spine Injury (CSI) in Children: A Multi-Centered Case-Control Analysis

  • RNA Biosignatures: A Paradigm Change for the Management of Young Febrile Infants

  • Teen Alcohol Screening in the Pediatric Emergency Care Applied Research Network (ASSESS) 

  • The Effectiveness of Oral Dexamethasone for Acute Bronchiolitis: A Multicenter Randomized Controlled Trial

Application of Transcriptional Signatures for Diagnosis of Febrile Infants Within the PECARN Network (TIG)

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  • Study Period: January 2009 - December 2010
  • Study Type: Prospective, observational clinical research
  • Study Enrollment: 1883
  • Consent: Yes

Purpose

Total # of eligible and consented subjects: 2246
Total # of patients with a sample obtained: 1883
Total # of subjects with an RNA sample analyzed: 279

The ultimate goal of this project was to incorporate a RNA-based diagnostic technology (called transcriptional signatures) to distinguish between bacterial and non-bacterial infections in otherwise well-appearing febrile infants who presented to the Emergency Department. The project aimed to create a PECARN wide infrastructure for conducting translational genomic research and demonstrate feasibility of screening, consenting, collecting, and processing of small volumes of blood samples to abstract high quality RNA from febrile infants. After initially defining bacterial and non-bacterial biosignatures, a limited validation of these diagnostic biosignatures was conducted on an independent group of febrile infants. Patient enrollment began in December 2007 and continued through May 2013 (this period includes the entire study population enrolled under the TIG [including feasibility portion prior to 2009] and NIH grants). This project was co-funded by NICHD.

This Public Use Dataset is based on a limited set of data for the overall study titled above. This dataset includes patients that were analyzed as part of the analysis for defining RNA transcriptional biosignatures to distinguish febrile infants 60 days of age and younger with bacterial and non-bacterial infections. The total number of samples analyzed for the TIG data set is 279. Enrollment period for the TIG data set is January 2009-December 2010.

I. Introduction and Definitions

  1. Application of Transcriptional Signatures for Diagnosis of Febrile Infants Within the PECARN Network (TIG) (the “STUDY”) Public Use Data Set (the “Data Set”) has been prepared by staff at the Data Coordinating Center, University of Utah School of Medicine (“UTAH”), on behalf of the Pediatric Emergency Care Applied Research Network (PECARN). In exchange for the ability to use the Data Set, the RECIPIENT agrees to comply with this Research Data Use Agreement (“Agreement”). The purpose of this availability is to provide the Data Set to investigators who wish to analyze the data in a secondary study designed to enhance the public health benefit of the original work.
  2. The RECIPIENT acknowledges its responsibility for ensuring adherence to the terms of this Agreement, subject to applicable Federal and State laws and regulations, including the privacy and security provisions of HIPAA and HITECH.
  3. The Data Set meets the definition of a De-identified Data Set as defined in 45 CFR Section 164.514(b).

II. Data Set Description and Support

  1. The Data Set will be provided as SAS datasets or CSV text files suitable for importation in statistical software. Electronic copies of the data worksheets, the final STUDY protocol, and a data dictionary will also be provided. No further support whatsoever will be provided by UTAH, STUDY investigators, PECARN or Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC) to the RECIPIENT.

III. Approved Research Uses

  1. The RECIPIENT agrees that it will use the Data Set solely in connection with a research project which will be completed in compliance with the terms of this Agreement.

IV. Non-Identification of Subjects

  1. The RECIPIENT agrees that it will not attempt to identify or contact the subjects or institutions that are included in the Data Set.

V. Non-Transferability of Data/Security of Data

  1. The RECIPIENT agrees to maintain control over the Data Set and further agrees not to release or distribute the Data Set in any form to any entity or individual for any purpose except as may be required by law or as permitted by this Agreement. If multiple individuals are collaborating and it is necessary to share the Data Set, each individual who will have a copy of the Data Set must execute a separate Agreement with UTAH.
  2. RECIPIENT agrees to use appropriate safeguards to ensure that Data Set is not used or disclosed in a manner inconsistent with this Agreement. RECIPIENT agrees to immediately report to UTAH any use or disclosure of the Data Set not in compliance with this Agreement and to provide all reasonable information requested by UTAH related to such use or disclosure.
  3. With respect to the Data Set, RECIPIENT agrees to comply with the security and privacy standards for Electronic Protected Health Information as defined in 45 CFR parts 160 and 164, Subpart C, as may be amended thereafter; RECIPIENT also agrees to comply with the Health Information Technology for Economic and Clinical Health (HITECH) Act effective February 17, 2009, and its implementing regulations.

VI. Duration of Agreement

  1. This RDUA will be in effect for a period of three (3) years from its effective date for the requested Data Set. The RDUA may be extended upon execution of a new RDUA document. At the end of the three (3) year period or extension, if another new extension is not in place, the RECIPIENT agrees to destroy all copies of the Data Set, including derivative datasets that contain individual-level information.

VII. Acknowledgment of Data Resource

  1. The RECIPIENT agrees to acknowledge the contribution of the STUDY in all oral and written presentations, disclosures, or publications resulting from any analyses conducted on the Data Set.
  2. The source of the Data Set will be acknowledged by including language similar to the following either in the acknowledgement or in the text of the manuscript: “This manuscript was prepared using the Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study (STUDY) Data Set obtained from UTAH, and does not necessarily reflect the opinions or views of the STUDY investigators or the Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC). The PECARN was funded by the HRSA/MCHB/EMSC.” Manuscripts and meeting abstracts may not use the name of the STUDY in the title, nor may the name of the STUDY or PECARN be included in the byline of the publication.

VIII. Publication

  1. The RECIPIENT agrees to provide to UTAH a copy of any manuscript thirty (30) days in advance of submission for publication, in order to ensure compliance with the terms of this Agreement. In addition, UTAH may in its discretion forward the manuscript to STUDY investigators for comment. If STUDY investigators choose to offer additional comments, these are provided only as courtesy. The RECIPIENT is not obligated to incorporate additional comments from STUDY investigators; however, these comments may provide the RECIPIENT with additional insights towards improving the manuscript.

IX. Duplication of Research

  1. The RECIPIENT acknowledges that other researchers are entitled to access to the Data Set on the same terms as RECIPIENT, and duplication of the RECIPIENT’s research may occur.

X. Non-Endorsement

  1. The RECIPIENT acknowledges that although reasonable efforts have been taken to ensure the accuracy and reliability of the Data Set, UTAH and the STUDY investigators do not and cannot warrant the research results or conclusions that may be obtained by using any data included therein. All contributors to the Data Set disclaim all warranties as to performance or fitness of the Data Set for any particular purpose.

XI. Termination and Violations

  1. UTAH may terminate this Agreement if RECIPIENT is in default of any terms and conditions of this Agreement and such default has not been remedied within 10 days after the date of written notice of such default. UTAH may unilaterally terminate this Agreement for any reason within 90 days written notice to RECIPIENT.
  2. Upon termination of this Agreement for any reason, RECIPIENT shall destroy any copies of Data Set in its possession, including derivative datasets that contain individual-level information, and shall document and report such destruction to UTAH.

XII. Amendments

  1. Amendments to this Agreement must be made in writing and signed by authorized representatives of all parties.

Request Form

Execution of the Agreement:

By entering the required information below and clicking “Agree”, the RECIPIENT certifies their agreement to adhere to the principles, policies and procedures for use of the Data Set as articulated in this Agreement.

Application of Transcriptional Signatures for Diagnosis of Febrile Infants Within the Pediatric Emergency Care Applied Research Network (PECARN)

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  • Study Period: December 2008 - May 2013
  • Study Type: Prospective, observational clinical research
  • Study Enrollment: 4778
  • Consent: Yes

Purpose

Total # of eligible and consented subjects: 6014
Total # of patients with a sample obtained: 4778

The ultimate goal of this project was to incorporate a RNA-based diagnostic technology (called transcriptional signatures) to distinguish between bacterial and non-bacterial infections in otherwise well-appearing febrile infants who presented to the Emergency Department. The project aimed to create a PECARN wide infrastructure for conducting translational genomic research and demonstrate feasibility of screening, consenting, collecting, and processing of small volumes of blood samples to abstract high quality RNA from febrile infants. After initially defining bacterial and non-bacterial biosignatures, a limited validation of these diagnostic biosignatures was conducted on an independent group of febrile infants. Patient enrollment began in December 2007 and continued through May 2013 (this period includes the entire study population enrolled under the TIG [including feasibility portion prior to 2009] and NIH grants). This project was co-funded by NICHD.

I. Introduction and Definitions

  1. Application of Transcriptional Signatures for Diagnosis of Febrile Infants Within the Pediatric Emergency Care Applied Research Network (PECARN) (the “STUDY”) Public Use Data Set (the “Data Set”) has been prepared by staff at the Data Coordinating Center, University of Utah School of Medicine (“UTAH”), on behalf of the Pediatric Emergency Care Applied Research Network (PECARN). In exchange for the ability to use the Data Set, the RECIPIENT agrees to comply with this Research Data Use Agreement (“Agreement”). The purpose of this availability is to provide the Data Set to investigators who wish to analyze the data in a secondary study designed to enhance the public health benefit of the original work.
  2. The RECIPIENT acknowledges its responsibility for ensuring adherence to the terms of this Agreement, subject to applicable Federal and State laws and regulations, including the privacy and security provisions of HIPAA and HITECH.
  3. The Data Set meets the definition of a De-identified Data Set as defined in 45 CFR Section 164.514(b).

II. Data Set Description and Support

  1. The Data Set will be provided as SAS datasets or CSV text files suitable for importation in statistical software. Electronic copies of the data worksheets, the final STUDY protocol, and a data dictionary will also be provided. No further support whatsoever will be provided by UTAH, STUDY investigators, PECARN or Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC) to the RECIPIENT.

III. Approved Research Uses

  1. The RECIPIENT agrees that it will use the Data Set solely in connection with a research project which will be completed in compliance with the terms of this Agreement.

IV. Non-Identification of Subjects

  1. The RECIPIENT agrees that it will not attempt to identify or contact the subjects or institutions that are included in the Data Set.

V. Non-Transferability of Data/Security of Data

  1. The RECIPIENT agrees to maintain control over the Data Set and further agrees not to release or distribute the Data Set in any form to any entity or individual for any purpose except as may be required by law or as permitted by this Agreement. If multiple individuals are collaborating and it is necessary to share the Data Set, each individual who will have a copy of the Data Set must execute a separate Agreement with UTAH.
  2. RECIPIENT agrees to use appropriate safeguards to ensure that Data Set is not used or disclosed in a manner inconsistent with this Agreement. RECIPIENT agrees to immediately report to UTAH any use or disclosure of the Data Set not in compliance with this Agreement and to provide all reasonable information requested by UTAH related to such use or disclosure.
  3. With respect to the Data Set, RECIPIENT agrees to comply with the security and privacy standards for Electronic Protected Health Information as defined in 45 CFR parts 160 and 164, Subpart C, as may be amended thereafter; RECIPIENT also agrees to comply with the Health Information Technology for Economic and Clinical Health (HITECH) Act effective February 17, 2009, and its implementing regulations.

VI. Duration of Agreement

  1. This RDUA will be in effect for a period of three (3) years from its effective date for the requested Data Set. The RDUA may be extended upon execution of a new RDUA document. At the end of the three (3) year period or extension, if another new extension is not in place, the RECIPIENT agrees to destroy all copies of the Data Set, including derivative datasets that contain individual-level information.

VII. Acknowledgment of Data Resource

  1. The RECIPIENT agrees to acknowledge the contribution of the STUDY in all oral and written presentations, disclosures, or publications resulting from any analyses conducted on the Data Set.
  2. The source of the Data Set will be acknowledged by including language similar to the following either in the acknowledgement or in the text of the manuscript: “This manuscript was prepared using the Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study (STUDY) Data Set obtained from UTAH, and does not necessarily reflect the opinions or views of the STUDY investigators or the Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC). The PECARN was funded by the HRSA/MCHB/EMSC.” Manuscripts and meeting abstracts may not use the name of the STUDY in the title, nor may the name of the STUDY or PECARN be included in the byline of the publication.

VIII. Publication

  1. The RECIPIENT agrees to provide to UTAH a copy of any manuscript thirty (30) days in advance of submission for publication, in order to ensure compliance with the terms of this Agreement. In addition, UTAH may in its discretion forward the manuscript to STUDY investigators for comment. If STUDY investigators choose to offer additional comments, these are provided only as courtesy. The RECIPIENT is not obligated to incorporate additional comments from STUDY investigators; however, these comments may provide the RECIPIENT with additional insights towards improving the manuscript.

IX. Duplication of Research

  1. The RECIPIENT acknowledges that other researchers are entitled to access to the Data Set on the same terms as RECIPIENT, and duplication of the RECIPIENT’s research may occur.

X. Non-Endorsement

  1. The RECIPIENT acknowledges that although reasonable efforts have been taken to ensure the accuracy and reliability of the Data Set, UTAH and the STUDY investigators do not and cannot warrant the research results or conclusions that may be obtained by using any data included therein. All contributors to the Data Set disclaim all warranties as to performance or fitness of the Data Set for any particular purpose.

XI. Termination and Violations

  1. UTAH may terminate this Agreement if RECIPIENT is in default of any terms and conditions of this Agreement and such default has not been remedied within 10 days after the date of written notice of such default. UTAH may unilaterally terminate this Agreement for any reason within 90 days written notice to RECIPIENT.
  2. Upon termination of this Agreement for any reason, RECIPIENT shall destroy any copies of Data Set in its possession, including derivative datasets that contain individual-level information, and shall document and report such destruction to UTAH.

XII. Amendments

  1. Amendments to this Agreement must be made in writing and signed by authorized representatives of all parties.

Request Form

Execution of the Agreement:

By entering the required information below and clicking “Agree”, the RECIPIENT certifies their agreement to adhere to the principles, policies and procedures for use of the Data Set as articulated in this Agreement.

CT Scan With IV Contrast Alone (CT IV): The Role of Intra-abdominal Fat (IAF) on the Sensitivity of CT IV to Visualize the Normal Appendix (IAF Appendix)

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  • Study Period: January 2009 - January 2010
  • Study Type: Retrospective and Prospective data collection
  • Study Enrollment: 280

Purpose

This was a retrospective study using a preexsisting database of abdominal CT scans. The purpose of this study was to examine whether intra-abdominal fat plays a role in visualization of a normal appendix and whether we can predict which patients will have adequate IAF, and thus forgo oral contrast. The authors aimed to determine the ability of radiologists to visualize the normal appendix with CT IV in children and to assess whether IAF adequacy affects this abilitiy. The study also aimed to assess the association between IAF adequacy and patient characteristics.

Data collection was performed at 16 PECARN hospitals enrolling children 3-18 years with a CT scan for whom appendectomy history was known. Radiologists re-read CT scans to assess appendix visualization and IAF adequacy.

I. Introduction and Definitions

  1. CT Scan With IV Contrast Alone (CT IV): The Role of Intra-abdominal Fat (IAF) on the Sensitivity of CT IV to Visualize the Normal Appendix (IAF Appendix) (the “STUDY”) Public Use Data Set (the “Data Set”) has been prepared by staff at the Data Coordinating Center, University of Utah School of Medicine (“UTAH”), on behalf of the Pediatric Emergency Care Applied Research Network (PECARN). In exchange for the ability to use the Data Set, the RECIPIENT agrees to comply with this Research Data Use Agreement (“Agreement”). The purpose of this availability is to provide the Data Set to investigators who wish to analyze the data in a secondary study designed to enhance the public health benefit of the original work.
  2. The RECIPIENT acknowledges its responsibility for ensuring adherence to the terms of this Agreement, subject to applicable Federal and State laws and regulations, including the privacy and security provisions of HIPAA and HITECH.
  3. The Data Set meets the definition of a De-identified Data Set as defined in 45 CFR Section 164.514(b).

II. Data Set Description and Support

  1. The Data Set will be provided as SAS datasets or CSV text files suitable for importation in statistical software. Electronic copies of the data worksheets, the final STUDY protocol, and a data dictionary will also be provided. No further support whatsoever will be provided by UTAH, STUDY investigators, PECARN or Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC) to the RECIPIENT.

III. Approved Research Uses

  1. The RECIPIENT agrees that it will use the Data Set solely in connection with a research project which will be completed in compliance with the terms of this Agreement.

IV. Non-Identification of Subjects

  1. The RECIPIENT agrees that it will not attempt to identify or contact the subjects or institutions that are included in the Data Set.

V. Non-Transferability of Data/Security of Data

  1. The RECIPIENT agrees to maintain control over the Data Set and further agrees not to release or distribute the Data Set in any form to any entity or individual for any purpose except as may be required by law or as permitted by this Agreement. If multiple individuals are collaborating and it is necessary to share the Data Set, each individual who will have a copy of the Data Set must execute a separate Agreement with UTAH.
  2. RECIPIENT agrees to use appropriate safeguards to ensure that Data Set is not used or disclosed in a manner inconsistent with this Agreement. RECIPIENT agrees to immediately report to UTAH any use or disclosure of the Data Set not in compliance with this Agreement and to provide all reasonable information requested by UTAH related to such use or disclosure.
  3. With respect to the Data Set, RECIPIENT agrees to comply with the security and privacy standards for Electronic Protected Health Information as defined in 45 CFR parts 160 and 164, Subpart C, as may be amended thereafter; RECIPIENT also agrees to comply with the Health Information Technology for Economic and Clinical Health (HITECH) Act effective February 17, 2009, and its implementing regulations.

VI. Duration of Agreement

  1. This RDUA will be in effect for a period of three (3) years from its effective date for the requested Data Set. The RDUA may be extended upon execution of a new RDUA document. At the end of the three (3) year period or extension, if another new extension is not in place, the RECIPIENT agrees to destroy all copies of the Data Set, including derivative datasets that contain individual-level information.

VII. Acknowledgment of Data Resource

  1. The RECIPIENT agrees to acknowledge the contribution of the STUDY in all oral and written presentations, disclosures, or publications resulting from any analyses conducted on the Data Set.
  2. The source of the Data Set will be acknowledged by including language similar to the following either in the acknowledgement or in the text of the manuscript: “This manuscript was prepared using the Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study (STUDY) Data Set obtained from UTAH, and does not necessarily reflect the opinions or views of the STUDY investigators or the Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC). The PECARN was funded by the HRSA/MCHB/EMSC.” Manuscripts and meeting abstracts may not use the name of the STUDY in the title, nor may the name of the STUDY or PECARN be included in the byline of the publication.

VIII. Publication

  1. The RECIPIENT agrees to provide to UTAH a copy of any manuscript thirty (30) days in advance of submission for publication, in order to ensure compliance with the terms of this Agreement. In addition, UTAH may in its discretion forward the manuscript to STUDY investigators for comment. If STUDY investigators choose to offer additional comments, these are provided only as courtesy. The RECIPIENT is not obligated to incorporate additional comments from STUDY investigators; however, these comments may provide the RECIPIENT with additional insights towards improving the manuscript.

IX. Duplication of Research

  1. The RECIPIENT acknowledges that other researchers are entitled to access to the Data Set on the same terms as RECIPIENT, and duplication of the RECIPIENT’s research may occur.

X. Non-Endorsement

  1. The RECIPIENT acknowledges that although reasonable efforts have been taken to ensure the accuracy and reliability of the Data Set, UTAH and the STUDY investigators do not and cannot warrant the research results or conclusions that may be obtained by using any data included therein. All contributors to the Data Set disclaim all warranties as to performance or fitness of the Data Set for any particular purpose.

XI. Termination and Violations

  1. UTAH may terminate this Agreement if RECIPIENT is in default of any terms and conditions of this Agreement and such default has not been remedied within 10 days after the date of written notice of such default. UTAH may unilaterally terminate this Agreement for any reason within 90 days written notice to RECIPIENT.
  2. Upon termination of this Agreement for any reason, RECIPIENT shall destroy any copies of Data Set in its possession, including derivative datasets that contain individual-level information, and shall document and report such destruction to UTAH.

XII. Amendments

  1. Amendments to this Agreement must be made in writing and signed by authorized representatives of all parties.

Request Form

Execution of the Agreement:

By entering the required information below and clicking “Agree”, the RECIPIENT certifies their agreement to adhere to the principles, policies and procedures for use of the Data Set as articulated in this Agreement.

Emergency Department Screen for Teens at Risk for Suicide (ED-STARS)

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  • Study Type: Observational
  • Study Enrollment: 10054
  • Consent: Yes

Purpose

Recognizing the importance of the emergency department (ED) as a setting for the identification of youth at risk for suicide, Emergency Department Screen for Teens at Risk for Suicide (ED-STARS) (5U01MH104311-02) was a multi-site collaborative project. The project was funded to improve identification of youth at risks for suicide in response to RFA-MH-14-070. ED-STARS is comprised of two studies, the primary aims of Study 1 were to develop a computerized adaptive screen (CAS) for predicting suicide attempts and to develop a CAS-based algorithm for risk stratification and triage for youth aged 12-17 years who presented to one of the PECARN EDs during randomly chosen screening shifts. We followed up with a subsample of these youth, enriched for suicide risk factors at 3 and 3 and 6 months. In study 2 we recruited a new sample of youth with the primary aims of validating the CAS, determine how it performs in comparison to a standard non-adaptive screen, and determine if a behavioral test for implicit suicidal thoughts has incremental value in predicting suicide attempts. The hypotheses of this study were as follows:

We hypothesize that the CAS will outperform the ASQ with respect to accuracy of prediction of suicide attempts.
We hypothesize that the IAT will add incrementally to the prediction of suicide attempts above and beyond CAS and ASQ scores
Patient enrollment took place beginning with study 1 in June 2015 and enrolled between June 2015 and July 2016 with the last follow-up procedures completed in September 2016. Study 2 enrolled between July 2017 and October 2018 with the last follow-up procedures completed in February 2019. This project was funded by the NIMH.

I. Introduction and Definitions

  1. Emergency Department Screen for Teens at Risk for Suicide (ED-STARS) (the “STUDY”) Public Use Data Set (the “Data Set”) has been prepared by staff at the Data Coordinating Center, University of Utah School of Medicine (“UTAH”), on behalf of the Pediatric Emergency Care Applied Research Network (PECARN). In exchange for the ability to use the Data Set, the RECIPIENT agrees to comply with this Research Data Use Agreement (“Agreement”). The purpose of this availability is to provide the Data Set to investigators who wish to analyze the data in a secondary study designed to enhance the public health benefit of the original work.
  2. The RECIPIENT acknowledges its responsibility for ensuring adherence to the terms of this Agreement, subject to applicable Federal and State laws and regulations, including the privacy and security provisions of HIPAA and HITECH.
  3. The Data Set meets the definition of a De-identified Data Set as defined in 45 CFR Section 164.514(b).

II. Data Set Description and Support

  1. The Data Set will be provided as SAS datasets or CSV text files suitable for importation in statistical software. Electronic copies of the data worksheets, the final STUDY protocol, and a data dictionary will also be provided. No further support whatsoever will be provided by UTAH, STUDY investigators, PECARN or Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC) to the RECIPIENT.

III. Approved Research Uses

  1. The RECIPIENT agrees that it will use the Data Set solely in connection with a research project which will be completed in compliance with the terms of this Agreement.

IV. Non-Identification of Subjects

  1. The RECIPIENT agrees that it will not attempt to identify or contact the subjects or institutions that are included in the Data Set.

V. Non-Transferability of Data/Security of Data

  1. The RECIPIENT agrees to maintain control over the Data Set and further agrees not to release or distribute the Data Set in any form to any entity or individual for any purpose except as may be required by law or as permitted by this Agreement. If multiple individuals are collaborating and it is necessary to share the Data Set, each individual who will have a copy of the Data Set must execute a separate Agreement with UTAH.
  2. RECIPIENT agrees to use appropriate safeguards to ensure that Data Set is not used or disclosed in a manner inconsistent with this Agreement. RECIPIENT agrees to immediately report to UTAH any use or disclosure of the Data Set not in compliance with this Agreement and to provide all reasonable information requested by UTAH related to such use or disclosure.
  3. With respect to the Data Set, RECIPIENT agrees to comply with the security and privacy standards for Electronic Protected Health Information as defined in 45 CFR parts 160 and 164, Subpart C, as may be amended thereafter; RECIPIENT also agrees to comply with the Health Information Technology for Economic and Clinical Health (HITECH) Act effective February 17, 2009, and its implementing regulations.

VI. Duration of Agreement

  1. This RDUA will be in effect for a period of three (3) years from its effective date for the requested Data Set. The RDUA may be extended upon execution of a new RDUA document. At the end of the three (3) year period or extension, if another new extension is not in place, the RECIPIENT agrees to destroy all copies of the Data Set, including derivative datasets that contain individual-level information.

VII. Acknowledgment of Data Resource

  1. The RECIPIENT agrees to acknowledge the contribution of the STUDY in all oral and written presentations, disclosures, or publications resulting from any analyses conducted on the Data Set.
  2. The source of the Data Set will be acknowledged by including language similar to the following either in the acknowledgement or in the text of the manuscript: “This manuscript was prepared using the Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study (STUDY) Data Set obtained from UTAH, and does not necessarily reflect the opinions or views of the STUDY investigators or the Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC). The PECARN was funded by the HRSA/MCHB/EMSC.” Manuscripts and meeting abstracts may not use the name of the STUDY in the title, nor may the name of the STUDY or PECARN be included in the byline of the publication.

VIII. Publication

  1. The RECIPIENT agrees to provide to UTAH a copy of any manuscript thirty (30) days in advance of submission for publication, in order to ensure compliance with the terms of this Agreement. In addition, UTAH may in its discretion forward the manuscript to STUDY investigators for comment. If STUDY investigators choose to offer additional comments, these are provided only as courtesy. The RECIPIENT is not obligated to incorporate additional comments from STUDY investigators; however, these comments may provide the RECIPIENT with additional insights towards improving the manuscript.

IX. Duplication of Research

  1. The RECIPIENT acknowledges that other researchers are entitled to access to the Data Set on the same terms as RECIPIENT, and duplication of the RECIPIENT’s research may occur.

X. Non-Endorsement

  1. The RECIPIENT acknowledges that although reasonable efforts have been taken to ensure the accuracy and reliability of the Data Set, UTAH and the STUDY investigators do not and cannot warrant the research results or conclusions that may be obtained by using any data included therein. All contributors to the Data Set disclaim all warranties as to performance or fitness of the Data Set for any particular purpose.

XI. Termination and Violations

  1. UTAH may terminate this Agreement if RECIPIENT is in default of any terms and conditions of this Agreement and such default has not been remedied within 10 days after the date of written notice of such default. UTAH may unilaterally terminate this Agreement for any reason within 90 days written notice to RECIPIENT.
  2. Upon termination of this Agreement for any reason, RECIPIENT shall destroy any copies of Data Set in its possession, including derivative datasets that contain individual-level information, and shall document and report such destruction to UTAH.

XII. Amendments

  1. Amendments to this Agreement must be made in writing and signed by authorized representatives of all parties.

Request Form

Execution of the Agreement:

By entering the required information below and clicking “Agree”, the RECIPIENT certifies their agreement to adhere to the principles, policies and procedures for use of the Data Set as articulated in this Agreement.

Fluid Therapy and Cerebral Injury in Pediatric Diabetic Ketoacidosis (Fluid Therapy in DKA)

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  • Study Period: February 2011 - January 2017
  • Study Type: Interventional
  • Study Enrollment: 1389
  • Consent: Yes

Purpose

To determine whether variations in fluid treatment protocols affect acute neurological outcomes of DKA and long-term neurocognitive function. This was accomplished by evaluating the effects that variations in intravenous fluids (IV) administration rates and sodium content had upon the frequency of mental status abnormalities and cerebral edema symptoms during DKA treatment and upon neurocognitive outcomes 3 months after discharge.

I. Introduction and Definitions

  1. Fluid Therapy and Cerebral Injury in Pediatric Diabetic Ketoacidosis (Fluid Therapy in DKA) (the “STUDY”) Public Use Data Set (the “Data Set”) has been prepared by staff at the Data Coordinating Center, University of Utah School of Medicine (“UTAH”), on behalf of the Pediatric Emergency Care Applied Research Network (PECARN). In exchange for the ability to use the Data Set, the RECIPIENT agrees to comply with this Research Data Use Agreement (“Agreement”). The purpose of this availability is to provide the Data Set to investigators who wish to analyze the data in a secondary study designed to enhance the public health benefit of the original work.
  2. The RECIPIENT acknowledges its responsibility for ensuring adherence to the terms of this Agreement, subject to applicable Federal and State laws and regulations, including the privacy and security provisions of HIPAA and HITECH.
  3. The Data Set meets the definition of a De-identified Data Set as defined in 45 CFR Section 164.514(b).

II. Data Set Description and Support

  1. The Data Set will be provided as SAS datasets or CSV text files suitable for importation in statistical software. Electronic copies of the data worksheets, the final STUDY protocol, and a data dictionary will also be provided. No further support whatsoever will be provided by UTAH, STUDY investigators, PECARN or Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC) to the RECIPIENT.

III. Approved Research Uses

  1. The RECIPIENT agrees that it will use the Data Set solely in connection with a research project which will be completed in compliance with the terms of this Agreement.

IV. Non-Identification of Subjects

  1. The RECIPIENT agrees that it will not attempt to identify or contact the subjects or institutions that are included in the Data Set.

V. Non-Transferability of Data/Security of Data

  1. The RECIPIENT agrees to maintain control over the Data Set and further agrees not to release or distribute the Data Set in any form to any entity or individual for any purpose except as may be required by law or as permitted by this Agreement. If multiple individuals are collaborating and it is necessary to share the Data Set, each individual who will have a copy of the Data Set must execute a separate Agreement with UTAH.
  2. RECIPIENT agrees to use appropriate safeguards to ensure that Data Set is not used or disclosed in a manner inconsistent with this Agreement. RECIPIENT agrees to immediately report to UTAH any use or disclosure of the Data Set not in compliance with this Agreement and to provide all reasonable information requested by UTAH related to such use or disclosure.
  3. With respect to the Data Set, RECIPIENT agrees to comply with the security and privacy standards for Electronic Protected Health Information as defined in 45 CFR parts 160 and 164, Subpart C, as may be amended thereafter; RECIPIENT also agrees to comply with the Health Information Technology for Economic and Clinical Health (HITECH) Act effective February 17, 2009, and its implementing regulations.

VI. Duration of Agreement

  1. This RDUA will be in effect for a period of three (3) years from its effective date for the requested Data Set. The RDUA may be extended upon execution of a new RDUA document. At the end of the three (3) year period or extension, if another new extension is not in place, the RECIPIENT agrees to destroy all copies of the Data Set, including derivative datasets that contain individual-level information.

VII. Acknowledgment of Data Resource

  1. The RECIPIENT agrees to acknowledge the contribution of the STUDY in all oral and written presentations, disclosures, or publications resulting from any analyses conducted on the Data Set.
  2. The source of the Data Set will be acknowledged by including language similar to the following either in the acknowledgement or in the text of the manuscript: “This manuscript was prepared using the Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study (STUDY) Data Set obtained from UTAH, and does not necessarily reflect the opinions or views of the STUDY investigators or the Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC). The PECARN was funded by the HRSA/MCHB/EMSC.” Manuscripts and meeting abstracts may not use the name of the STUDY in the title, nor may the name of the STUDY or PECARN be included in the byline of the publication.

VIII. Publication

  1. The RECIPIENT agrees to provide to UTAH a copy of any manuscript thirty (30) days in advance of submission for publication, in order to ensure compliance with the terms of this Agreement. In addition, UTAH may in its discretion forward the manuscript to STUDY investigators for comment. If STUDY investigators choose to offer additional comments, these are provided only as courtesy. The RECIPIENT is not obligated to incorporate additional comments from STUDY investigators; however, these comments may provide the RECIPIENT with additional insights towards improving the manuscript.

IX. Duplication of Research

  1. The RECIPIENT acknowledges that other researchers are entitled to access to the Data Set on the same terms as RECIPIENT, and duplication of the RECIPIENT’s research may occur.

X. Non-Endorsement

  1. The RECIPIENT acknowledges that although reasonable efforts have been taken to ensure the accuracy and reliability of the Data Set, UTAH and the STUDY investigators do not and cannot warrant the research results or conclusions that may be obtained by using any data included therein. All contributors to the Data Set disclaim all warranties as to performance or fitness of the Data Set for any particular purpose.

XI. Termination and Violations

  1. UTAH may terminate this Agreement if RECIPIENT is in default of any terms and conditions of this Agreement and such default has not been remedied within 10 days after the date of written notice of such default. UTAH may unilaterally terminate this Agreement for any reason within 90 days written notice to RECIPIENT.
  2. Upon termination of this Agreement for any reason, RECIPIENT shall destroy any copies of Data Set in its possession, including derivative datasets that contain individual-level information, and shall document and report such destruction to UTAH.

XII. Amendments

  1. Amendments to this Agreement must be made in writing and signed by authorized representatives of all parties.

Request Form

Execution of the Agreement:

By entering the required information below and clicking “Agree”, the RECIPIENT certifies their agreement to adhere to the principles, policies and procedures for use of the Data Set as articulated in this Agreement.

Hypothermia After Pediatric Cardiac Arrest – Out of Hospital Trial

No Dataset Available
  • Study Period: September 2009 - June 2014
  • Study Type: Clinical Trial
  • Study Enrollment: 295

Purpose

If you are interested in using the THAPCA Trials Out of Hospital Public Use Dataset, please click here to start the process: https://biolincc.nhlbi.nih.gov/studies/thapca/ The OH PUD is housed at BioLINCC, the biologic and data repository for the National, Heart, Lung, and Blood Institute.

I. Introduction and Definitions

  1. Hypothermia After Pediatric Cardiac Arrest - Out of Hospital Trial (the “STUDY”) Public Use Data Set (the “Data Set”) has been prepared by staff at the Data Coordinating Center, University of Utah School of Medicine (“UTAH”), on behalf of the Pediatric Emergency Care Applied Research Network (PECARN). In exchange for the ability to use the Data Set, the RECIPIENT agrees to comply with this Research Data Use Agreement (“Agreement”). The purpose of this availability is to provide the Data Set to investigators who wish to analyze the data in a secondary study designed to enhance the public health benefit of the original work.
  2. The RECIPIENT acknowledges its responsibility for ensuring adherence to the terms of this Agreement, subject to applicable Federal and State laws and regulations, including the privacy and security provisions of HIPAA and HITECH.
  3. The Data Set meets the definition of a De-identified Data Set as defined in 45 CFR Section 164.514(b).

II. Data Set Description and Support

  1. The Data Set will be provided as SAS datasets or CSV text files suitable for importation in statistical software. Electronic copies of the data worksheets, the final STUDY protocol, and a data dictionary will also be provided. No further support whatsoever will be provided by UTAH, STUDY investigators, PECARN or Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC) to the RECIPIENT.

III. Approved Research Uses

  1. The RECIPIENT agrees that it will use the Data Set solely in connection with a research project which will be completed in compliance with the terms of this Agreement.

IV. Non-Identification of Subjects

  1. The RECIPIENT agrees that it will not attempt to identify or contact the subjects or institutions that are included in the Data Set.

V. Non-Transferability of Data/Security of Data

  1. The RECIPIENT agrees to maintain control over the Data Set and further agrees not to release or distribute the Data Set in any form to any entity or individual for any purpose except as may be required by law or as permitted by this Agreement. If multiple individuals are collaborating and it is necessary to share the Data Set, each individual who will have a copy of the Data Set must execute a separate Agreement with UTAH.
  2. RECIPIENT agrees to use appropriate safeguards to ensure that Data Set is not used or disclosed in a manner inconsistent with this Agreement. RECIPIENT agrees to immediately report to UTAH any use or disclosure of the Data Set not in compliance with this Agreement and to provide all reasonable information requested by UTAH related to such use or disclosure.
  3. With respect to the Data Set, RECIPIENT agrees to comply with the security and privacy standards for Electronic Protected Health Information as defined in 45 CFR parts 160 and 164, Subpart C, as may be amended thereafter; RECIPIENT also agrees to comply with the Health Information Technology for Economic and Clinical Health (HITECH) Act effective February 17, 2009, and its implementing regulations.

VI. Duration of Agreement

  1. This RDUA will be in effect for a period of three (3) years from its effective date for the requested Data Set. The RDUA may be extended upon execution of a new RDUA document. At the end of the three (3) year period or extension, if another new extension is not in place, the RECIPIENT agrees to destroy all copies of the Data Set, including derivative datasets that contain individual-level information.

VII. Acknowledgment of Data Resource

  1. The RECIPIENT agrees to acknowledge the contribution of the STUDY in all oral and written presentations, disclosures, or publications resulting from any analyses conducted on the Data Set.
  2. The source of the Data Set will be acknowledged by including language similar to the following either in the acknowledgement or in the text of the manuscript: “This manuscript was prepared using the Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study (STUDY) Data Set obtained from UTAH, and does not necessarily reflect the opinions or views of the STUDY investigators or the Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC). The PECARN was funded by the HRSA/MCHB/EMSC.” Manuscripts and meeting abstracts may not use the name of the STUDY in the title, nor may the name of the STUDY or PECARN be included in the byline of the publication.

VIII. Publication

  1. The RECIPIENT agrees to provide to UTAH a copy of any manuscript thirty (30) days in advance of submission for publication, in order to ensure compliance with the terms of this Agreement. In addition, UTAH may in its discretion forward the manuscript to STUDY investigators for comment. If STUDY investigators choose to offer additional comments, these are provided only as courtesy. The RECIPIENT is not obligated to incorporate additional comments from STUDY investigators; however, these comments may provide the RECIPIENT with additional insights towards improving the manuscript.

IX. Duplication of Research

  1. The RECIPIENT acknowledges that other researchers are entitled to access to the Data Set on the same terms as RECIPIENT, and duplication of the RECIPIENT’s research may occur.

X. Non-Endorsement

  1. The RECIPIENT acknowledges that although reasonable efforts have been taken to ensure the accuracy and reliability of the Data Set, UTAH and the STUDY investigators do not and cannot warrant the research results or conclusions that may be obtained by using any data included therein. All contributors to the Data Set disclaim all warranties as to performance or fitness of the Data Set for any particular purpose.

XI. Termination and Violations

  1. UTAH may terminate this Agreement if RECIPIENT is in default of any terms and conditions of this Agreement and such default has not been remedied within 10 days after the date of written notice of such default. UTAH may unilaterally terminate this Agreement for any reason within 90 days written notice to RECIPIENT.
  2. Upon termination of this Agreement for any reason, RECIPIENT shall destroy any copies of Data Set in its possession, including derivative datasets that contain individual-level information, and shall document and report such destruction to UTAH.

XII. Amendments

  1. Amendments to this Agreement must be made in writing and signed by authorized representatives of all parties.

Request Form

Execution of the Agreement:

By entering the required information below and clicking “Agree”, the RECIPIENT certifies their agreement to adhere to the principles, policies and procedures for use of the Data Set as articulated in this Agreement.

Hypothermia After Pediatric Cardiac Arrest (Planning Grant)

No Dataset Available

Purpose

In this clinical trial planning grant, 15 PECARN children's hospitals with intensive care units retrospectively reviewed medical records of patients between 1 day and 18 years of age who sustained a cardiac arrest with return of spontaneous circulation in either the outpatient or inpatient setting. Characterization of this population included arrest specific events and etiology, patient characteristics, hospital course, interventions received hospital survival, and neurologic outcome. This information was used to create inclusion and exclusion criteria, and to calculate sample size requirements for the ongoing Therapeutic Hypothermia after Pediatric Cardiac Arrest (THAPCA) randomized controlled trial of hypothermia following pediatric cardiac arrest.

I. Introduction and Definitions

  1. Hypothermia After Pediatric Cardiac Arrest (Planning Grant) (the “STUDY”) Public Use Data Set (the “Data Set”) has been prepared by staff at the Data Coordinating Center, University of Utah School of Medicine (“UTAH”), on behalf of the Pediatric Emergency Care Applied Research Network (PECARN). In exchange for the ability to use the Data Set, the RECIPIENT agrees to comply with this Research Data Use Agreement (“Agreement”). The purpose of this availability is to provide the Data Set to investigators who wish to analyze the data in a secondary study designed to enhance the public health benefit of the original work.
  2. The RECIPIENT acknowledges its responsibility for ensuring adherence to the terms of this Agreement, subject to applicable Federal and State laws and regulations, including the privacy and security provisions of HIPAA and HITECH.
  3. The Data Set meets the definition of a De-identified Data Set as defined in 45 CFR Section 164.514(b).

II. Data Set Description and Support

  1. The Data Set will be provided as SAS datasets or CSV text files suitable for importation in statistical software. Electronic copies of the data worksheets, the final STUDY protocol, and a data dictionary will also be provided. No further support whatsoever will be provided by UTAH, STUDY investigators, PECARN or Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC) to the RECIPIENT.

III. Approved Research Uses

  1. The RECIPIENT agrees that it will use the Data Set solely in connection with a research project which will be completed in compliance with the terms of this Agreement.

IV. Non-Identification of Subjects

  1. The RECIPIENT agrees that it will not attempt to identify or contact the subjects or institutions that are included in the Data Set.

V. Non-Transferability of Data/Security of Data

  1. The RECIPIENT agrees to maintain control over the Data Set and further agrees not to release or distribute the Data Set in any form to any entity or individual for any purpose except as may be required by law or as permitted by this Agreement. If multiple individuals are collaborating and it is necessary to share the Data Set, each individual who will have a copy of the Data Set must execute a separate Agreement with UTAH.
  2. RECIPIENT agrees to use appropriate safeguards to ensure that Data Set is not used or disclosed in a manner inconsistent with this Agreement. RECIPIENT agrees to immediately report to UTAH any use or disclosure of the Data Set not in compliance with this Agreement and to provide all reasonable information requested by UTAH related to such use or disclosure.
  3. With respect to the Data Set, RECIPIENT agrees to comply with the security and privacy standards for Electronic Protected Health Information as defined in 45 CFR parts 160 and 164, Subpart C, as may be amended thereafter; RECIPIENT also agrees to comply with the Health Information Technology for Economic and Clinical Health (HITECH) Act effective February 17, 2009, and its implementing regulations.

VI. Duration of Agreement

  1. This RDUA will be in effect for a period of three (3) years from its effective date for the requested Data Set. The RDUA may be extended upon execution of a new RDUA document. At the end of the three (3) year period or extension, if another new extension is not in place, the RECIPIENT agrees to destroy all copies of the Data Set, including derivative datasets that contain individual-level information.

VII. Acknowledgment of Data Resource

  1. The RECIPIENT agrees to acknowledge the contribution of the STUDY in all oral and written presentations, disclosures, or publications resulting from any analyses conducted on the Data Set.
  2. The source of the Data Set will be acknowledged by including language similar to the following either in the acknowledgement or in the text of the manuscript: “This manuscript was prepared using the Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study (STUDY) Data Set obtained from UTAH, and does not necessarily reflect the opinions or views of the STUDY investigators or the Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC). The PECARN was funded by the HRSA/MCHB/EMSC.” Manuscripts and meeting abstracts may not use the name of the STUDY in the title, nor may the name of the STUDY or PECARN be included in the byline of the publication.

VIII. Publication

  1. The RECIPIENT agrees to provide to UTAH a copy of any manuscript thirty (30) days in advance of submission for publication, in order to ensure compliance with the terms of this Agreement. In addition, UTAH may in its discretion forward the manuscript to STUDY investigators for comment. If STUDY investigators choose to offer additional comments, these are provided only as courtesy. The RECIPIENT is not obligated to incorporate additional comments from STUDY investigators; however, these comments may provide the RECIPIENT with additional insights towards improving the manuscript.

IX. Duplication of Research

  1. The RECIPIENT acknowledges that other researchers are entitled to access to the Data Set on the same terms as RECIPIENT, and duplication of the RECIPIENT’s research may occur.

X. Non-Endorsement

  1. The RECIPIENT acknowledges that although reasonable efforts have been taken to ensure the accuracy and reliability of the Data Set, UTAH and the STUDY investigators do not and cannot warrant the research results or conclusions that may be obtained by using any data included therein. All contributors to the Data Set disclaim all warranties as to performance or fitness of the Data Set for any particular purpose.

XI. Termination and Violations

  1. UTAH may terminate this Agreement if RECIPIENT is in default of any terms and conditions of this Agreement and such default has not been remedied within 10 days after the date of written notice of such default. UTAH may unilaterally terminate this Agreement for any reason within 90 days written notice to RECIPIENT.
  2. Upon termination of this Agreement for any reason, RECIPIENT shall destroy any copies of Data Set in its possession, including derivative datasets that contain individual-level information, and shall document and report such destruction to UTAH.

XII. Amendments

  1. Amendments to this Agreement must be made in writing and signed by authorized representatives of all parties.

Request Form

Execution of the Agreement:

By entering the required information below and clicking “Agree”, the RECIPIENT certifies their agreement to adhere to the principles, policies and procedures for use of the Data Set as articulated in this Agreement.

Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study.

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  • Study Period: June 2004 - September 2006
  • Study Type: Observational
  • Study Enrollment: 42412
  • Consent: Waiver of consent at some sites; verbal consent for telephone follow up at other sites

Purpose

This prospective observational cohort study enrolled children younger than 18 years of age with mild head trauma evaluated in 25 PECARN emergency departments. The goal was: to derive a clinical prediction rule to accurately identify children at near zero risk of clinically important traumatic brain injury after blunt trauma. We enrolled subjects presenting within 24 hours of head trauma with Glasgow Coma Scale scores of 14-15. These validated prediction rules identified children at very low risk of clinically important traumatic brain injury for whom CT scans can routinely be obviated.

I. Introduction and Definitions

  1. Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study. (the “STUDY”) Public Use Data Set (the “Data Set”) has been prepared by staff at the Data Coordinating Center, University of Utah School of Medicine (“UTAH”), on behalf of the Pediatric Emergency Care Applied Research Network (PECARN). In exchange for the ability to use the Data Set, the RECIPIENT agrees to comply with this Research Data Use Agreement (“Agreement”). The purpose of this availability is to provide the Data Set to investigators who wish to analyze the data in a secondary study designed to enhance the public health benefit of the original work.
  2. The RECIPIENT acknowledges its responsibility for ensuring adherence to the terms of this Agreement, subject to applicable Federal and State laws and regulations, including the privacy and security provisions of HIPAA and HITECH.
  3. The Data Set meets the definition of a De-identified Data Set as defined in 45 CFR Section 164.514(b).

II. Data Set Description and Support

  1. The Data Set will be provided as SAS datasets or CSV text files suitable for importation in statistical software. Electronic copies of the data worksheets, the final STUDY protocol, and a data dictionary will also be provided. No further support whatsoever will be provided by UTAH, STUDY investigators, PECARN or Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC) to the RECIPIENT.

III. Approved Research Uses

  1. The RECIPIENT agrees that it will use the Data Set solely in connection with a research project which will be completed in compliance with the terms of this Agreement.

IV. Non-Identification of Subjects

  1. The RECIPIENT agrees that it will not attempt to identify or contact the subjects or institutions that are included in the Data Set.

V. Non-Transferability of Data/Security of Data

  1. The RECIPIENT agrees to maintain control over the Data Set and further agrees not to release or distribute the Data Set in any form to any entity or individual for any purpose except as may be required by law or as permitted by this Agreement. If multiple individuals are collaborating and it is necessary to share the Data Set, each individual who will have a copy of the Data Set must execute a separate Agreement with UTAH.
  2. RECIPIENT agrees to use appropriate safeguards to ensure that Data Set is not used or disclosed in a manner inconsistent with this Agreement. RECIPIENT agrees to immediately report to UTAH any use or disclosure of the Data Set not in compliance with this Agreement and to provide all reasonable information requested by UTAH related to such use or disclosure.
  3. With respect to the Data Set, RECIPIENT agrees to comply with the security and privacy standards for Electronic Protected Health Information as defined in 45 CFR parts 160 and 164, Subpart C, as may be amended thereafter; RECIPIENT also agrees to comply with the Health Information Technology for Economic and Clinical Health (HITECH) Act effective February 17, 2009, and its implementing regulations.

VI. Duration of Agreement

  1. This RDUA will be in effect for a period of three (3) years from its effective date for the requested Data Set. The RDUA may be extended upon execution of a new RDUA document. At the end of the three (3) year period or extension, if another new extension is not in place, the RECIPIENT agrees to destroy all copies of the Data Set, including derivative datasets that contain individual-level information.

VII. Acknowledgment of Data Resource

  1. The RECIPIENT agrees to acknowledge the contribution of the STUDY in all oral and written presentations, disclosures, or publications resulting from any analyses conducted on the Data Set.
  2. The source of the Data Set will be acknowledged by including language similar to the following either in the acknowledgement or in the text of the manuscript: “This manuscript was prepared using the Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study (STUDY) Data Set obtained from UTAH, and does not necessarily reflect the opinions or views of the STUDY investigators or the Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC). The PECARN was funded by the HRSA/MCHB/EMSC.” Manuscripts and meeting abstracts may not use the name of the STUDY in the title, nor may the name of the STUDY or PECARN be included in the byline of the publication.

VIII. Publication

  1. The RECIPIENT agrees to provide to UTAH a copy of any manuscript thirty (30) days in advance of submission for publication, in order to ensure compliance with the terms of this Agreement. In addition, UTAH may in its discretion forward the manuscript to STUDY investigators for comment. If STUDY investigators choose to offer additional comments, these are provided only as courtesy. The RECIPIENT is not obligated to incorporate additional comments from STUDY investigators; however, these comments may provide the RECIPIENT with additional insights towards improving the manuscript.

IX. Duplication of Research

  1. The RECIPIENT acknowledges that other researchers are entitled to access to the Data Set on the same terms as RECIPIENT, and duplication of the RECIPIENT’s research may occur.

X. Non-Endorsement

  1. The RECIPIENT acknowledges that although reasonable efforts have been taken to ensure the accuracy and reliability of the Data Set, UTAH and the STUDY investigators do not and cannot warrant the research results or conclusions that may be obtained by using any data included therein. All contributors to the Data Set disclaim all warranties as to performance or fitness of the Data Set for any particular purpose.

XI. Termination and Violations

  1. UTAH may terminate this Agreement if RECIPIENT is in default of any terms and conditions of this Agreement and such default has not been remedied within 10 days after the date of written notice of such default. UTAH may unilaterally terminate this Agreement for any reason within 90 days written notice to RECIPIENT.
  2. Upon termination of this Agreement for any reason, RECIPIENT shall destroy any copies of Data Set in its possession, including derivative datasets that contain individual-level information, and shall document and report such destruction to UTAH.

XII. Amendments

  1. Amendments to this Agreement must be made in writing and signed by authorized representatives of all parties.

Request Form

Execution of the Agreement:

By entering the required information below and clicking “Agree”, the RECIPIENT certifies their agreement to adhere to the principles, policies and procedures for use of the Data Set as articulated in this Agreement.

Identifying Children at Very Low Risk of Clinically Important Blunt Abdominal Injuries

Download Data Back to Dataset Info
  • Study Period: May 2007 - January 2010
  • Study Type: Observational
  • Study Enrollment: 12044
  • Consent: Waiver of consent at some sites; verbal consent for telephone follow up at other sites

Purpose

This prospective observational cohort study enrolled children younger than 18 years of age with blunt torso trauma who were evaluated in 20 PECARN emergency departments. The overall objective of this study is to develop a clinical decision rule for appropriate use of abdominal computerized tomography (CT) scanning in children with blunt torso trauma (to include the chest, abdomen and pelvis). The goal of the study was a prediction rule to identify children at very low risk for intra-abdominal injuries undergoing acute intervention for who computed tomography (CT) could be obviated. The study was funded by the Centers for Disease Control and Prevention (1 R49 CE001002). A prediction rule consisting of 7 patient history and physical examination findings, without laboratory or ultrasonographic information, identifies children with blunt torso trauma who are at very low risk for intra-abdominal injury undergoing acute intervention. These findings require external validation before implementation.

I. Introduction and Definitions

  1. Identifying Children at Very Low Risk of Clinically Important Blunt Abdominal Injuries (the “STUDY”) Public Use Data Set (the “Data Set”) has been prepared by staff at the Data Coordinating Center, University of Utah School of Medicine (“UTAH”), on behalf of the Pediatric Emergency Care Applied Research Network (PECARN). In exchange for the ability to use the Data Set, the RECIPIENT agrees to comply with this Research Data Use Agreement (“Agreement”). The purpose of this availability is to provide the Data Set to investigators who wish to analyze the data in a secondary study designed to enhance the public health benefit of the original work.
  2. The RECIPIENT acknowledges its responsibility for ensuring adherence to the terms of this Agreement, subject to applicable Federal and State laws and regulations, including the privacy and security provisions of HIPAA and HITECH.
  3. The Data Set meets the definition of a De-identified Data Set as defined in 45 CFR Section 164.514(b).

II. Data Set Description and Support

  1. The Data Set will be provided as SAS datasets or CSV text files suitable for importation in statistical software. Electronic copies of the data worksheets, the final STUDY protocol, and a data dictionary will also be provided. No further support whatsoever will be provided by UTAH, STUDY investigators, PECARN or Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC) to the RECIPIENT.

III. Approved Research Uses

  1. The RECIPIENT agrees that it will use the Data Set solely in connection with a research project which will be completed in compliance with the terms of this Agreement.

IV. Non-Identification of Subjects

  1. The RECIPIENT agrees that it will not attempt to identify or contact the subjects or institutions that are included in the Data Set.

V. Non-Transferability of Data/Security of Data

  1. The RECIPIENT agrees to maintain control over the Data Set and further agrees not to release or distribute the Data Set in any form to any entity or individual for any purpose except as may be required by law or as permitted by this Agreement. If multiple individuals are collaborating and it is necessary to share the Data Set, each individual who will have a copy of the Data Set must execute a separate Agreement with UTAH.
  2. RECIPIENT agrees to use appropriate safeguards to ensure that Data Set is not used or disclosed in a manner inconsistent with this Agreement. RECIPIENT agrees to immediately report to UTAH any use or disclosure of the Data Set not in compliance with this Agreement and to provide all reasonable information requested by UTAH related to such use or disclosure.
  3. With respect to the Data Set, RECIPIENT agrees to comply with the security and privacy standards for Electronic Protected Health Information as defined in 45 CFR parts 160 and 164, Subpart C, as may be amended thereafter; RECIPIENT also agrees to comply with the Health Information Technology for Economic and Clinical Health (HITECH) Act effective February 17, 2009, and its implementing regulations.

VI. Duration of Agreement

  1. This RDUA will be in effect for a period of three (3) years from its effective date for the requested Data Set. The RDUA may be extended upon execution of a new RDUA document. At the end of the three (3) year period or extension, if another new extension is not in place, the RECIPIENT agrees to destroy all copies of the Data Set, including derivative datasets that contain individual-level information.

VII. Acknowledgment of Data Resource

  1. The RECIPIENT agrees to acknowledge the contribution of the STUDY in all oral and written presentations, disclosures, or publications resulting from any analyses conducted on the Data Set.
  2. The source of the Data Set will be acknowledged by including language similar to the following either in the acknowledgement or in the text of the manuscript: “This manuscript was prepared using the Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study (STUDY) Data Set obtained from UTAH, and does not necessarily reflect the opinions or views of the STUDY investigators or the Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC). The PECARN was funded by the HRSA/MCHB/EMSC.” Manuscripts and meeting abstracts may not use the name of the STUDY in the title, nor may the name of the STUDY or PECARN be included in the byline of the publication.

VIII. Publication

  1. The RECIPIENT agrees to provide to UTAH a copy of any manuscript thirty (30) days in advance of submission for publication, in order to ensure compliance with the terms of this Agreement. In addition, UTAH may in its discretion forward the manuscript to STUDY investigators for comment. If STUDY investigators choose to offer additional comments, these are provided only as courtesy. The RECIPIENT is not obligated to incorporate additional comments from STUDY investigators; however, these comments may provide the RECIPIENT with additional insights towards improving the manuscript.

IX. Duplication of Research

  1. The RECIPIENT acknowledges that other researchers are entitled to access to the Data Set on the same terms as RECIPIENT, and duplication of the RECIPIENT’s research may occur.

X. Non-Endorsement

  1. The RECIPIENT acknowledges that although reasonable efforts have been taken to ensure the accuracy and reliability of the Data Set, UTAH and the STUDY investigators do not and cannot warrant the research results or conclusions that may be obtained by using any data included therein. All contributors to the Data Set disclaim all warranties as to performance or fitness of the Data Set for any particular purpose.

XI. Termination and Violations

  1. UTAH may terminate this Agreement if RECIPIENT is in default of any terms and conditions of this Agreement and such default has not been remedied within 10 days after the date of written notice of such default. UTAH may unilaterally terminate this Agreement for any reason within 90 days written notice to RECIPIENT.
  2. Upon termination of this Agreement for any reason, RECIPIENT shall destroy any copies of Data Set in its possession, including derivative datasets that contain individual-level information, and shall document and report such destruction to UTAH.

XII. Amendments

  1. Amendments to this Agreement must be made in writing and signed by authorized representatives of all parties.

Request Form

Execution of the Agreement:

By entering the required information below and clicking “Agree”, the RECIPIENT certifies their agreement to adhere to the principles, policies and procedures for use of the Data Set as articulated in this Agreement.

Impact of Emergency Department Probiotic Treatment of Pediatric Gastroenteritis (Probiotics)

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  • Study Type: Interventional
  • Study Enrollment: 971
  • Consent: Yes

Purpose

This was a prospective, randomized, double-blind trial involving children 3 months to 4 years of age with acute gastroenteritis who presented to one of 10 U.S. pediatric emergency departments. The purpose of this study was to provide definitive evidence for, or against, using probiotic therapy for acute gastroenteritis. Participants were randomized to receive either probiotic therapy (Lactobacillus rhamnosus GG, ATCC 53103 (LGG)) or placebo. Participants were followed-up with by phone daily until symptoms resolved. A follow-up phone call also occurred once treatment had completed, on day 5. Additional follow-up by phone occurred on day 14 for outcome assessment, and at 1, 3, 6, 9 and 12 months for long-term safety outcomes. The hypotheses of this study were as follows:

1. In children with acute gastroenteritis, probiotic administration in the emergency department will be associated with a clinically-important decrease in the proportion of children suffering from moderate-severe disease, defined by a validated Modified Vesikari Score = 9, compared to placebo.
2. In children with acute gastroenteritis, probiotic administration will not be associated with serious adverse events, and will have a similar rate of side effects (e.g. bloating, fever) as compared to placebo-treated children.
Patient enrollment took place between July 2014 and July 2017 with last follow up procedures completed in August 2018. This project was funded by NICHD.

I. Introduction and Definitions

  1. Impact of Emergency Department Probiotic Treatment of Pediatric Gastroenteritis (Probiotics) (the “STUDY”) Public Use Data Set (the “Data Set”) has been prepared by staff at the Data Coordinating Center, University of Utah School of Medicine (“UTAH”), on behalf of the Pediatric Emergency Care Applied Research Network (PECARN). In exchange for the ability to use the Data Set, the RECIPIENT agrees to comply with this Research Data Use Agreement (“Agreement”). The purpose of this availability is to provide the Data Set to investigators who wish to analyze the data in a secondary study designed to enhance the public health benefit of the original work.
  2. The RECIPIENT acknowledges its responsibility for ensuring adherence to the terms of this Agreement, subject to applicable Federal and State laws and regulations, including the privacy and security provisions of HIPAA and HITECH.
  3. The Data Set meets the definition of a De-identified Data Set as defined in 45 CFR Section 164.514(b).

II. Data Set Description and Support

  1. The Data Set will be provided as SAS datasets or CSV text files suitable for importation in statistical software. Electronic copies of the data worksheets, the final STUDY protocol, and a data dictionary will also be provided. No further support whatsoever will be provided by UTAH, STUDY investigators, PECARN or Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC) to the RECIPIENT.

III. Approved Research Uses

  1. The RECIPIENT agrees that it will use the Data Set solely in connection with a research project which will be completed in compliance with the terms of this Agreement.

IV. Non-Identification of Subjects

  1. The RECIPIENT agrees that it will not attempt to identify or contact the subjects or institutions that are included in the Data Set.

V. Non-Transferability of Data/Security of Data

  1. The RECIPIENT agrees to maintain control over the Data Set and further agrees not to release or distribute the Data Set in any form to any entity or individual for any purpose except as may be required by law or as permitted by this Agreement. If multiple individuals are collaborating and it is necessary to share the Data Set, each individual who will have a copy of the Data Set must execute a separate Agreement with UTAH.
  2. RECIPIENT agrees to use appropriate safeguards to ensure that Data Set is not used or disclosed in a manner inconsistent with this Agreement. RECIPIENT agrees to immediately report to UTAH any use or disclosure of the Data Set not in compliance with this Agreement and to provide all reasonable information requested by UTAH related to such use or disclosure.
  3. With respect to the Data Set, RECIPIENT agrees to comply with the security and privacy standards for Electronic Protected Health Information as defined in 45 CFR parts 160 and 164, Subpart C, as may be amended thereafter; RECIPIENT also agrees to comply with the Health Information Technology for Economic and Clinical Health (HITECH) Act effective February 17, 2009, and its implementing regulations.

VI. Duration of Agreement

  1. This RDUA will be in effect for a period of three (3) years from its effective date for the requested Data Set. The RDUA may be extended upon execution of a new RDUA document. At the end of the three (3) year period or extension, if another new extension is not in place, the RECIPIENT agrees to destroy all copies of the Data Set, including derivative datasets that contain individual-level information.

VII. Acknowledgment of Data Resource

  1. The RECIPIENT agrees to acknowledge the contribution of the STUDY in all oral and written presentations, disclosures, or publications resulting from any analyses conducted on the Data Set.
  2. The source of the Data Set will be acknowledged by including language similar to the following either in the acknowledgement or in the text of the manuscript: “This manuscript was prepared using the Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study (STUDY) Data Set obtained from UTAH, and does not necessarily reflect the opinions or views of the STUDY investigators or the Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC). The PECARN was funded by the HRSA/MCHB/EMSC.” Manuscripts and meeting abstracts may not use the name of the STUDY in the title, nor may the name of the STUDY or PECARN be included in the byline of the publication.

VIII. Publication

  1. The RECIPIENT agrees to provide to UTAH a copy of any manuscript thirty (30) days in advance of submission for publication, in order to ensure compliance with the terms of this Agreement. In addition, UTAH may in its discretion forward the manuscript to STUDY investigators for comment. If STUDY investigators choose to offer additional comments, these are provided only as courtesy. The RECIPIENT is not obligated to incorporate additional comments from STUDY investigators; however, these comments may provide the RECIPIENT with additional insights towards improving the manuscript.

IX. Duplication of Research

  1. The RECIPIENT acknowledges that other researchers are entitled to access to the Data Set on the same terms as RECIPIENT, and duplication of the RECIPIENT’s research may occur.

X. Non-Endorsement

  1. The RECIPIENT acknowledges that although reasonable efforts have been taken to ensure the accuracy and reliability of the Data Set, UTAH and the STUDY investigators do not and cannot warrant the research results or conclusions that may be obtained by using any data included therein. All contributors to the Data Set disclaim all warranties as to performance or fitness of the Data Set for any particular purpose.

XI. Termination and Violations

  1. UTAH may terminate this Agreement if RECIPIENT is in default of any terms and conditions of this Agreement and such default has not been remedied within 10 days after the date of written notice of such default. UTAH may unilaterally terminate this Agreement for any reason within 90 days written notice to RECIPIENT.
  2. Upon termination of this Agreement for any reason, RECIPIENT shall destroy any copies of Data Set in its possession, including derivative datasets that contain individual-level information, and shall document and report such destruction to UTAH.

XII. Amendments

  1. Amendments to this Agreement must be made in writing and signed by authorized representatives of all parties.

Request Form

Execution of the Agreement:

By entering the required information below and clicking “Agree”, the RECIPIENT certifies their agreement to adhere to the principles, policies and procedures for use of the Data Set as articulated in this Agreement.

Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis (Magnesium in Crisis [MAGIC])

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  • Study Period: December 2010 - March 2014
  • Study Type: Interventional (IND)
  • Study Enrollment: 208
  • Consent: Yes

Purpose

This was a multi-center, randomized, double-blind, placebo controlled trial of participants aged 4-21 years old with sickle cell anemia (defined by Hb SS or Hb Sß0 thalassemia disease) who presented to the emergency department with a sickle cell vasoocclusive crisis. The purpose of this study was to determine the safety and efficacy of intravenous magnesium in shortening the duration of a pain crisis when added to standard care in children with sickle cell disease (SCD) who are hospitalized for an acute pain crisis. Patients were randomized to receive either the study drug or placebo every eight hours for a total of six doses, or until discharge (whichever occurred first). Patients were followed up by phone one week after discharge to assess rehospitalization rates and returned to the sickle cell clinic for follow up one to three months after discharge. The hypotheses of this study were as follows:

intravenous magnesium is an effective agent for the treatment of patients hospitalized for an acute sickle cell pain episode;
the addition of intravenous magnesium sulfate to standard inpatient therapy is safe for patients hospitalized with an acute sickle cell pain episode;
the beneficial effect of intravenous magnesium is, in part, due to increased endothelial cell nitric oxide production and/or improvement of endothelial dysfunction.
children receiving magnesium therapy will have better health-related quality of life (HRQL) at completion of treatment and better short term outcomes after hospital discharge than those receiving placebo therapy;
the PedsQL Sickle Cell Disease module will be responsive to temporal changes in health status of the child
Patient enrollment took place between December 2010-March 2014 with last follow up procedures completed in May 2014. This project was co-funded by NICHD and NHLBI.

I. Introduction and Definitions

  1. Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis (Magnesium in Crisis [MAGIC]) (the “STUDY”) Public Use Data Set (the “Data Set”) has been prepared by staff at the Data Coordinating Center, University of Utah School of Medicine (“UTAH”), on behalf of the Pediatric Emergency Care Applied Research Network (PECARN). In exchange for the ability to use the Data Set, the RECIPIENT agrees to comply with this Research Data Use Agreement (“Agreement”). The purpose of this availability is to provide the Data Set to investigators who wish to analyze the data in a secondary study designed to enhance the public health benefit of the original work.
  2. The RECIPIENT acknowledges its responsibility for ensuring adherence to the terms of this Agreement, subject to applicable Federal and State laws and regulations, including the privacy and security provisions of HIPAA and HITECH.
  3. The Data Set meets the definition of a De-identified Data Set as defined in 45 CFR Section 164.514(b).

II. Data Set Description and Support

  1. The Data Set will be provided as SAS datasets or CSV text files suitable for importation in statistical software. Electronic copies of the data worksheets, the final STUDY protocol, and a data dictionary will also be provided. No further support whatsoever will be provided by UTAH, STUDY investigators, PECARN or Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC) to the RECIPIENT.

III. Approved Research Uses

  1. The RECIPIENT agrees that it will use the Data Set solely in connection with a research project which will be completed in compliance with the terms of this Agreement.

IV. Non-Identification of Subjects

  1. The RECIPIENT agrees that it will not attempt to identify or contact the subjects or institutions that are included in the Data Set.

V. Non-Transferability of Data/Security of Data

  1. The RECIPIENT agrees to maintain control over the Data Set and further agrees not to release or distribute the Data Set in any form to any entity or individual for any purpose except as may be required by law or as permitted by this Agreement. If multiple individuals are collaborating and it is necessary to share the Data Set, each individual who will have a copy of the Data Set must execute a separate Agreement with UTAH.
  2. RECIPIENT agrees to use appropriate safeguards to ensure that Data Set is not used or disclosed in a manner inconsistent with this Agreement. RECIPIENT agrees to immediately report to UTAH any use or disclosure of the Data Set not in compliance with this Agreement and to provide all reasonable information requested by UTAH related to such use or disclosure.
  3. With respect to the Data Set, RECIPIENT agrees to comply with the security and privacy standards for Electronic Protected Health Information as defined in 45 CFR parts 160 and 164, Subpart C, as may be amended thereafter; RECIPIENT also agrees to comply with the Health Information Technology for Economic and Clinical Health (HITECH) Act effective February 17, 2009, and its implementing regulations.

VI. Duration of Agreement

  1. This RDUA will be in effect for a period of three (3) years from its effective date for the requested Data Set. The RDUA may be extended upon execution of a new RDUA document. At the end of the three (3) year period or extension, if another new extension is not in place, the RECIPIENT agrees to destroy all copies of the Data Set, including derivative datasets that contain individual-level information.

VII. Acknowledgment of Data Resource

  1. The RECIPIENT agrees to acknowledge the contribution of the STUDY in all oral and written presentations, disclosures, or publications resulting from any analyses conducted on the Data Set.
  2. The source of the Data Set will be acknowledged by including language similar to the following either in the acknowledgement or in the text of the manuscript: “This manuscript was prepared using the Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study (STUDY) Data Set obtained from UTAH, and does not necessarily reflect the opinions or views of the STUDY investigators or the Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC). The PECARN was funded by the HRSA/MCHB/EMSC.” Manuscripts and meeting abstracts may not use the name of the STUDY in the title, nor may the name of the STUDY or PECARN be included in the byline of the publication.

VIII. Publication

  1. The RECIPIENT agrees to provide to UTAH a copy of any manuscript thirty (30) days in advance of submission for publication, in order to ensure compliance with the terms of this Agreement. In addition, UTAH may in its discretion forward the manuscript to STUDY investigators for comment. If STUDY investigators choose to offer additional comments, these are provided only as courtesy. The RECIPIENT is not obligated to incorporate additional comments from STUDY investigators; however, these comments may provide the RECIPIENT with additional insights towards improving the manuscript.

IX. Duplication of Research

  1. The RECIPIENT acknowledges that other researchers are entitled to access to the Data Set on the same terms as RECIPIENT, and duplication of the RECIPIENT’s research may occur.

X. Non-Endorsement

  1. The RECIPIENT acknowledges that although reasonable efforts have been taken to ensure the accuracy and reliability of the Data Set, UTAH and the STUDY investigators do not and cannot warrant the research results or conclusions that may be obtained by using any data included therein. All contributors to the Data Set disclaim all warranties as to performance or fitness of the Data Set for any particular purpose.

XI. Termination and Violations

  1. UTAH may terminate this Agreement if RECIPIENT is in default of any terms and conditions of this Agreement and such default has not been remedied within 10 days after the date of written notice of such default. UTAH may unilaterally terminate this Agreement for any reason within 90 days written notice to RECIPIENT.
  2. Upon termination of this Agreement for any reason, RECIPIENT shall destroy any copies of Data Set in its possession, including derivative datasets that contain individual-level information, and shall document and report such destruction to UTAH.

XII. Amendments

  1. Amendments to this Agreement must be made in writing and signed by authorized representatives of all parties.

Request Form

Execution of the Agreement:

By entering the required information below and clicking “Agree”, the RECIPIENT certifies their agreement to adhere to the principles, policies and procedures for use of the Data Set as articulated in this Agreement.

Multi-Center Validation of an Implicit Review Instrument to Measure Quality of Care Provided to Children in the Emergency Department

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  • Study Type: Retrospective Review
  • Study Enrollment: 650
  • Consent: No

Purpose

The overall objective of this proposal is to validate a structured implicit review instrument that measures the quality of care provided to children presenting to EDs, and to identify factors associated with differences in quality of care provided to these children among a diverse cohort of EDs and patients across the United States. The implicit review instrument entails peer review of medical records by experts in the field, and has been shown (in studies involving one teaching hospital and several rural hospitals) to have acceptable reliability, internal consistency and validity. By applying this structured implicit review instrument to the national PECARN collaborative, the project will demonstrate that the instrument is reliable and valid, and can be used to measure quality of care for any cohort of children in any ED setting (given its successful prior application in rural EDs). The project additionally should identify factors related to quality of care that will assist health policy makers to generate specific policy recommendations with regard to training, staffing and practice guidelines. Furthermore, healthcare academicians, researchers, providers, and policy makers in developing recommendations for quality benchmarks, standards and policies aimed at improving the quality of care delivered to children presenting to EDs across the country could use the validated instrument and results of this study in combination with other national quality efforts.

I. Introduction and Definitions

  1. Multi-Center Validation of an Implicit Review Instrument to Measure Quality of Care Provided to Children in the Emergency Department (the “STUDY”) Public Use Data Set (the “Data Set”) has been prepared by staff at the Data Coordinating Center, University of Utah School of Medicine (“UTAH”), on behalf of the Pediatric Emergency Care Applied Research Network (PECARN). In exchange for the ability to use the Data Set, the RECIPIENT agrees to comply with this Research Data Use Agreement (“Agreement”). The purpose of this availability is to provide the Data Set to investigators who wish to analyze the data in a secondary study designed to enhance the public health benefit of the original work.
  2. The RECIPIENT acknowledges its responsibility for ensuring adherence to the terms of this Agreement, subject to applicable Federal and State laws and regulations, including the privacy and security provisions of HIPAA and HITECH.
  3. The Data Set meets the definition of a De-identified Data Set as defined in 45 CFR Section 164.514(b).

II. Data Set Description and Support

  1. The Data Set will be provided as SAS datasets or CSV text files suitable for importation in statistical software. Electronic copies of the data worksheets, the final STUDY protocol, and a data dictionary will also be provided. No further support whatsoever will be provided by UTAH, STUDY investigators, PECARN or Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC) to the RECIPIENT.

III. Approved Research Uses

  1. The RECIPIENT agrees that it will use the Data Set solely in connection with a research project which will be completed in compliance with the terms of this Agreement.

IV. Non-Identification of Subjects

  1. The RECIPIENT agrees that it will not attempt to identify or contact the subjects or institutions that are included in the Data Set.

V. Non-Transferability of Data/Security of Data

  1. The RECIPIENT agrees to maintain control over the Data Set and further agrees not to release or distribute the Data Set in any form to any entity or individual for any purpose except as may be required by law or as permitted by this Agreement. If multiple individuals are collaborating and it is necessary to share the Data Set, each individual who will have a copy of the Data Set must execute a separate Agreement with UTAH.
  2. RECIPIENT agrees to use appropriate safeguards to ensure that Data Set is not used or disclosed in a manner inconsistent with this Agreement. RECIPIENT agrees to immediately report to UTAH any use or disclosure of the Data Set not in compliance with this Agreement and to provide all reasonable information requested by UTAH related to such use or disclosure.
  3. With respect to the Data Set, RECIPIENT agrees to comply with the security and privacy standards for Electronic Protected Health Information as defined in 45 CFR parts 160 and 164, Subpart C, as may be amended thereafter; RECIPIENT also agrees to comply with the Health Information Technology for Economic and Clinical Health (HITECH) Act effective February 17, 2009, and its implementing regulations.

VI. Duration of Agreement

  1. This RDUA will be in effect for a period of three (3) years from its effective date for the requested Data Set. The RDUA may be extended upon execution of a new RDUA document. At the end of the three (3) year period or extension, if another new extension is not in place, the RECIPIENT agrees to destroy all copies of the Data Set, including derivative datasets that contain individual-level information.

VII. Acknowledgment of Data Resource

  1. The RECIPIENT agrees to acknowledge the contribution of the STUDY in all oral and written presentations, disclosures, or publications resulting from any analyses conducted on the Data Set.
  2. The source of the Data Set will be acknowledged by including language similar to the following either in the acknowledgement or in the text of the manuscript: “This manuscript was prepared using the Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study (STUDY) Data Set obtained from UTAH, and does not necessarily reflect the opinions or views of the STUDY investigators or the Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC). The PECARN was funded by the HRSA/MCHB/EMSC.” Manuscripts and meeting abstracts may not use the name of the STUDY in the title, nor may the name of the STUDY or PECARN be included in the byline of the publication.

VIII. Publication

  1. The RECIPIENT agrees to provide to UTAH a copy of any manuscript thirty (30) days in advance of submission for publication, in order to ensure compliance with the terms of this Agreement. In addition, UTAH may in its discretion forward the manuscript to STUDY investigators for comment. If STUDY investigators choose to offer additional comments, these are provided only as courtesy. The RECIPIENT is not obligated to incorporate additional comments from STUDY investigators; however, these comments may provide the RECIPIENT with additional insights towards improving the manuscript.

IX. Duplication of Research

  1. The RECIPIENT acknowledges that other researchers are entitled to access to the Data Set on the same terms as RECIPIENT, and duplication of the RECIPIENT’s research may occur.

X. Non-Endorsement

  1. The RECIPIENT acknowledges that although reasonable efforts have been taken to ensure the accuracy and reliability of the Data Set, UTAH and the STUDY investigators do not and cannot warrant the research results or conclusions that may be obtained by using any data included therein. All contributors to the Data Set disclaim all warranties as to performance or fitness of the Data Set for any particular purpose.

XI. Termination and Violations

  1. UTAH may terminate this Agreement if RECIPIENT is in default of any terms and conditions of this Agreement and such default has not been remedied within 10 days after the date of written notice of such default. UTAH may unilaterally terminate this Agreement for any reason within 90 days written notice to RECIPIENT.
  2. Upon termination of this Agreement for any reason, RECIPIENT shall destroy any copies of Data Set in its possession, including derivative datasets that contain individual-level information, and shall document and report such destruction to UTAH.

XII. Amendments

  1. Amendments to this Agreement must be made in writing and signed by authorized representatives of all parties.

Request Form

Execution of the Agreement:

By entering the required information below and clicking “Agree”, the RECIPIENT certifies their agreement to adhere to the principles, policies and procedures for use of the Data Set as articulated in this Agreement.

PECARN Core Data Project (PCDP) 2002-2014

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  • Study Period: January 2002 - December 2014
  • Study Type: Registry
  • Study Enrollment: 11000000
  • Consent: Waived

Purpose

The PECARN Core Data Project (PCDP) database is a collection of basic epidemiological information about emergency department patient visits from participating hospitals within the Pediatric Emergency Care Applied Research Network (PECARN). Data were submitted electronically by each participating ED annually, and processed and stored by the Data Coordinating Center. New datasets are added to the Public Use Data Set list annually with a lag time of 18 months from each respective year's end.

I. Introduction and Definitions

  1. PECARN Core Data Project (PCDP) 2002-2014 (the “STUDY”) Public Use Data Set (the “Data Set”) has been prepared by staff at the Data Coordinating Center, University of Utah School of Medicine (“UTAH”), on behalf of the Pediatric Emergency Care Applied Research Network (PECARN). In exchange for the ability to use the Data Set, the RECIPIENT agrees to comply with this Research Data Use Agreement (“Agreement”). The purpose of this availability is to provide the Data Set to investigators who wish to analyze the data in a secondary study designed to enhance the public health benefit of the original work.
  2. The RECIPIENT acknowledges its responsibility for ensuring adherence to the terms of this Agreement, subject to applicable Federal and State laws and regulations, including the privacy and security provisions of HIPAA and HITECH.
  3. The Data Set meets the definition of a De-identified Data Set as defined in 45 CFR Section 164.514(b).

II. Data Set Description and Support

  1. The Data Set will be provided as SAS datasets or CSV text files suitable for importation in statistical software. Electronic copies of the data worksheets, the final STUDY protocol, and a data dictionary will also be provided. No further support whatsoever will be provided by UTAH, STUDY investigators, PECARN or Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC) to the RECIPIENT.

III. Approved Research Uses

  1. The RECIPIENT agrees that it will use the Data Set solely in connection with a research project which will be completed in compliance with the terms of this Agreement.

IV. Non-Identification of Subjects

  1. The RECIPIENT agrees that it will not attempt to identify or contact the subjects or institutions that are included in the Data Set.

V. Non-Transferability of Data/Security of Data

  1. The RECIPIENT agrees to maintain control over the Data Set and further agrees not to release or distribute the Data Set in any form to any entity or individual for any purpose except as may be required by law or as permitted by this Agreement. If multiple individuals are collaborating and it is necessary to share the Data Set, each individual who will have a copy of the Data Set must execute a separate Agreement with UTAH.
  2. RECIPIENT agrees to use appropriate safeguards to ensure that Data Set is not used or disclosed in a manner inconsistent with this Agreement. RECIPIENT agrees to immediately report to UTAH any use or disclosure of the Data Set not in compliance with this Agreement and to provide all reasonable information requested by UTAH related to such use or disclosure.
  3. With respect to the Data Set, RECIPIENT agrees to comply with the security and privacy standards for Electronic Protected Health Information as defined in 45 CFR parts 160 and 164, Subpart C, as may be amended thereafter; RECIPIENT also agrees to comply with the Health Information Technology for Economic and Clinical Health (HITECH) Act effective February 17, 2009, and its implementing regulations.

VI. Duration of Agreement

  1. This RDUA will be in effect for a period of three (3) years from its effective date for the requested Data Set. The RDUA may be extended upon execution of a new RDUA document. At the end of the three (3) year period or extension, if another new extension is not in place, the RECIPIENT agrees to destroy all copies of the Data Set, including derivative datasets that contain individual-level information.

VII. Acknowledgment of Data Resource

  1. The RECIPIENT agrees to acknowledge the contribution of the STUDY in all oral and written presentations, disclosures, or publications resulting from any analyses conducted on the Data Set.
  2. The source of the Data Set will be acknowledged by including language similar to the following either in the acknowledgement or in the text of the manuscript: “This manuscript was prepared using the Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study (STUDY) Data Set obtained from UTAH, and does not necessarily reflect the opinions or views of the STUDY investigators or the Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC). The PECARN was funded by the HRSA/MCHB/EMSC.” Manuscripts and meeting abstracts may not use the name of the STUDY in the title, nor may the name of the STUDY or PECARN be included in the byline of the publication.

VIII. Publication

  1. The RECIPIENT agrees to provide to UTAH a copy of any manuscript thirty (30) days in advance of submission for publication, in order to ensure compliance with the terms of this Agreement. In addition, UTAH may in its discretion forward the manuscript to STUDY investigators for comment. If STUDY investigators choose to offer additional comments, these are provided only as courtesy. The RECIPIENT is not obligated to incorporate additional comments from STUDY investigators; however, these comments may provide the RECIPIENT with additional insights towards improving the manuscript.

IX. Duplication of Research

  1. The RECIPIENT acknowledges that other researchers are entitled to access to the Data Set on the same terms as RECIPIENT, and duplication of the RECIPIENT’s research may occur.

X. Non-Endorsement

  1. The RECIPIENT acknowledges that although reasonable efforts have been taken to ensure the accuracy and reliability of the Data Set, UTAH and the STUDY investigators do not and cannot warrant the research results or conclusions that may be obtained by using any data included therein. All contributors to the Data Set disclaim all warranties as to performance or fitness of the Data Set for any particular purpose.

XI. Termination and Violations

  1. UTAH may terminate this Agreement if RECIPIENT is in default of any terms and conditions of this Agreement and such default has not been remedied within 10 days after the date of written notice of such default. UTAH may unilaterally terminate this Agreement for any reason within 90 days written notice to RECIPIENT.
  2. Upon termination of this Agreement for any reason, RECIPIENT shall destroy any copies of Data Set in its possession, including derivative datasets that contain individual-level information, and shall document and report such destruction to UTAH.

XII. Amendments

  1. Amendments to this Agreement must be made in writing and signed by authorized representatives of all parties.

Request Form

Execution of the Agreement:

By entering the required information below and clicking “Agree”, the RECIPIENT certifies their agreement to adhere to the principles, policies and procedures for use of the Data Set as articulated in this Agreement.

PECARN Core Data Project Ten-Day (2003)

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  • Study Period: February 2003 - April 2003
  • Study Enrollment: 12756
  • Consent: Waived

Purpose

Study Period: 10 randomly selected days in Feb 1 - April 30,2003
Enrollment: 12,756 visits; 252 fractures and 861 asthma diagnoses

The PECARN Core Data Project (PCDP) Ten-Day dataset is a subset analysis of the PCDP registry data. Its purpose was to measure quantitative agreement and representativeness between the electronic submission and subsequent medical record abstraction. Ten-Day Submission data were obtained by abstraction of emergency department charts on 10 randomly selected days in the first quarter of 2003, with up to 60 charts per institution. Additional data were collected on subjects with long bone fractures or asthma diagnoses.

I. Introduction and Definitions

  1. PECARN Core Data Project Ten-Day (2003) (the “STUDY”) Public Use Data Set (the “Data Set”) has been prepared by staff at the Data Coordinating Center, University of Utah School of Medicine (“UTAH”), on behalf of the Pediatric Emergency Care Applied Research Network (PECARN). In exchange for the ability to use the Data Set, the RECIPIENT agrees to comply with this Research Data Use Agreement (“Agreement”). The purpose of this availability is to provide the Data Set to investigators who wish to analyze the data in a secondary study designed to enhance the public health benefit of the original work.
  2. The RECIPIENT acknowledges its responsibility for ensuring adherence to the terms of this Agreement, subject to applicable Federal and State laws and regulations, including the privacy and security provisions of HIPAA and HITECH.
  3. The Data Set meets the definition of a De-identified Data Set as defined in 45 CFR Section 164.514(b).

II. Data Set Description and Support

  1. The Data Set will be provided as SAS datasets or CSV text files suitable for importation in statistical software. Electronic copies of the data worksheets, the final STUDY protocol, and a data dictionary will also be provided. No further support whatsoever will be provided by UTAH, STUDY investigators, PECARN or Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC) to the RECIPIENT.

III. Approved Research Uses

  1. The RECIPIENT agrees that it will use the Data Set solely in connection with a research project which will be completed in compliance with the terms of this Agreement.

IV. Non-Identification of Subjects

  1. The RECIPIENT agrees that it will not attempt to identify or contact the subjects or institutions that are included in the Data Set.

V. Non-Transferability of Data/Security of Data

  1. The RECIPIENT agrees to maintain control over the Data Set and further agrees not to release or distribute the Data Set in any form to any entity or individual for any purpose except as may be required by law or as permitted by this Agreement. If multiple individuals are collaborating and it is necessary to share the Data Set, each individual who will have a copy of the Data Set must execute a separate Agreement with UTAH.
  2. RECIPIENT agrees to use appropriate safeguards to ensure that Data Set is not used or disclosed in a manner inconsistent with this Agreement. RECIPIENT agrees to immediately report to UTAH any use or disclosure of the Data Set not in compliance with this Agreement and to provide all reasonable information requested by UTAH related to such use or disclosure.
  3. With respect to the Data Set, RECIPIENT agrees to comply with the security and privacy standards for Electronic Protected Health Information as defined in 45 CFR parts 160 and 164, Subpart C, as may be amended thereafter; RECIPIENT also agrees to comply with the Health Information Technology for Economic and Clinical Health (HITECH) Act effective February 17, 2009, and its implementing regulations.

VI. Duration of Agreement

  1. This RDUA will be in effect for a period of three (3) years from its effective date for the requested Data Set. The RDUA may be extended upon execution of a new RDUA document. At the end of the three (3) year period or extension, if another new extension is not in place, the RECIPIENT agrees to destroy all copies of the Data Set, including derivative datasets that contain individual-level information.

VII. Acknowledgment of Data Resource

  1. The RECIPIENT agrees to acknowledge the contribution of the STUDY in all oral and written presentations, disclosures, or publications resulting from any analyses conducted on the Data Set.
  2. The source of the Data Set will be acknowledged by including language similar to the following either in the acknowledgement or in the text of the manuscript: “This manuscript was prepared using the Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study (STUDY) Data Set obtained from UTAH, and does not necessarily reflect the opinions or views of the STUDY investigators or the Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC). The PECARN was funded by the HRSA/MCHB/EMSC.” Manuscripts and meeting abstracts may not use the name of the STUDY in the title, nor may the name of the STUDY or PECARN be included in the byline of the publication.

VIII. Publication

  1. The RECIPIENT agrees to provide to UTAH a copy of any manuscript thirty (30) days in advance of submission for publication, in order to ensure compliance with the terms of this Agreement. In addition, UTAH may in its discretion forward the manuscript to STUDY investigators for comment. If STUDY investigators choose to offer additional comments, these are provided only as courtesy. The RECIPIENT is not obligated to incorporate additional comments from STUDY investigators; however, these comments may provide the RECIPIENT with additional insights towards improving the manuscript.

IX. Duplication of Research

  1. The RECIPIENT acknowledges that other researchers are entitled to access to the Data Set on the same terms as RECIPIENT, and duplication of the RECIPIENT’s research may occur.

X. Non-Endorsement

  1. The RECIPIENT acknowledges that although reasonable efforts have been taken to ensure the accuracy and reliability of the Data Set, UTAH and the STUDY investigators do not and cannot warrant the research results or conclusions that may be obtained by using any data included therein. All contributors to the Data Set disclaim all warranties as to performance or fitness of the Data Set for any particular purpose.

XI. Termination and Violations

  1. UTAH may terminate this Agreement if RECIPIENT is in default of any terms and conditions of this Agreement and such default has not been remedied within 10 days after the date of written notice of such default. UTAH may unilaterally terminate this Agreement for any reason within 90 days written notice to RECIPIENT.
  2. Upon termination of this Agreement for any reason, RECIPIENT shall destroy any copies of Data Set in its possession, including derivative datasets that contain individual-level information, and shall document and report such destruction to UTAH.

XII. Amendments

  1. Amendments to this Agreement must be made in writing and signed by authorized representatives of all parties.

Request Form

Execution of the Agreement:

By entering the required information below and clicking “Agree”, the RECIPIENT certifies their agreement to adhere to the principles, policies and procedures for use of the Data Set as articulated in this Agreement.

PECARN Research Network Registry Project (Registry) 2012-2021 Public Use Dataset (PUD)

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  • Study Period: January 2012 - December 2021
  • Study Type: Registry
  • Study Enrollment: 5,831,284 visits
  • Consent: Waived

Purpose

The PECARN Registry is a collection of deidentified electronic health record data from participating pediatric and community emergency departments (ED). Data were submitted electronically to the EMSC Data Center (EDC), where it was stored and analyzed. PECARN Registry data have been used to calculate and report stakeholder-prioritized emergency care performance improvement measures for pediatric medical and trauma conditions as part of a quality improvement (QI) project. Registry data have been used to support additional QI efforts, research proposals, both retrospective and prospective research projects, and generated numerous publications. Data included in this public use data set contains demographic, patient flow, and clinical data including triage category, vitals, pain scores, GCS scores, ICD-9 and ICD-10 diagnosis codes, imaging and medication information from 12 sites (nine quaternary children’s hospital EDs and three affiliated secondary community hospital EDs) and span 10 years (2012-2021).

I. Introduction and Definitions

  1. PECARN Research Network Registry Project (Registry) 2012-2021 Public Use Dataset (PUD) (the “STUDY”) Public Use Data Set (the “Data Set”) has been prepared by staff at the Data Coordinating Center, University of Utah School of Medicine (“UTAH”), on behalf of the Pediatric Emergency Care Applied Research Network (PECARN). In exchange for the ability to use the Data Set, the RECIPIENT agrees to comply with this Research Data Use Agreement (“Agreement”). The purpose of this availability is to provide the Data Set to investigators who wish to analyze the data in a secondary study designed to enhance the public health benefit of the original work.
  2. The RECIPIENT acknowledges its responsibility for ensuring adherence to the terms of this Agreement, subject to applicable Federal and State laws and regulations, including the privacy and security provisions of HIPAA and HITECH.
  3. The Data Set meets the definition of a De-identified Data Set as defined in 45 CFR Section 164.514(b).

II. Data Set Description and Support

  1. The Data Set will be provided as SAS datasets or CSV text files suitable for importation in statistical software. Electronic copies of the data worksheets, the final STUDY protocol, and a data dictionary will also be provided. No further support whatsoever will be provided by UTAH, STUDY investigators, PECARN or Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC) to the RECIPIENT.

III. Approved Research Uses

  1. The RECIPIENT agrees that it will use the Data Set solely in connection with a research project which will be completed in compliance with the terms of this Agreement.

IV. Non-Identification of Subjects

  1. The RECIPIENT agrees that it will not attempt to identify or contact the subjects or institutions that are included in the Data Set.

V. Non-Transferability of Data/Security of Data

  1. The RECIPIENT agrees to maintain control over the Data Set and further agrees not to release or distribute the Data Set in any form to any entity or individual for any purpose except as may be required by law or as permitted by this Agreement. If multiple individuals are collaborating and it is necessary to share the Data Set, each individual who will have a copy of the Data Set must execute a separate Agreement with UTAH.
  2. RECIPIENT agrees to use appropriate safeguards to ensure that Data Set is not used or disclosed in a manner inconsistent with this Agreement. RECIPIENT agrees to immediately report to UTAH any use or disclosure of the Data Set not in compliance with this Agreement and to provide all reasonable information requested by UTAH related to such use or disclosure.
  3. With respect to the Data Set, RECIPIENT agrees to comply with the security and privacy standards for Electronic Protected Health Information as defined in 45 CFR parts 160 and 164, Subpart C, as may be amended thereafter; RECIPIENT also agrees to comply with the Health Information Technology for Economic and Clinical Health (HITECH) Act effective February 17, 2009, and its implementing regulations.

VI. Duration of Agreement

  1. This RDUA will be in effect for a period of three (3) years from its effective date for the requested Data Set. The RDUA may be extended upon execution of a new RDUA document. At the end of the three (3) year period or extension, if another new extension is not in place, the RECIPIENT agrees to destroy all copies of the Data Set, including derivative datasets that contain individual-level information.

VII. Acknowledgment of Data Resource

  1. The RECIPIENT agrees to acknowledge the contribution of the STUDY in all oral and written presentations, disclosures, or publications resulting from any analyses conducted on the Data Set.
  2. The source of the Data Set will be acknowledged by including language similar to the following either in the acknowledgement or in the text of the manuscript: “This manuscript was prepared using the Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study (STUDY) Data Set obtained from UTAH, and does not necessarily reflect the opinions or views of the STUDY investigators or the Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC). The PECARN was funded by the HRSA/MCHB/EMSC.” Manuscripts and meeting abstracts may not use the name of the STUDY in the title, nor may the name of the STUDY or PECARN be included in the byline of the publication.

VIII. Publication

  1. The RECIPIENT agrees to provide to UTAH a copy of any manuscript thirty (30) days in advance of submission for publication, in order to ensure compliance with the terms of this Agreement. In addition, UTAH may in its discretion forward the manuscript to STUDY investigators for comment. If STUDY investigators choose to offer additional comments, these are provided only as courtesy. The RECIPIENT is not obligated to incorporate additional comments from STUDY investigators; however, these comments may provide the RECIPIENT with additional insights towards improving the manuscript.

IX. Duplication of Research

  1. The RECIPIENT acknowledges that other researchers are entitled to access to the Data Set on the same terms as RECIPIENT, and duplication of the RECIPIENT’s research may occur.

X. Non-Endorsement

  1. The RECIPIENT acknowledges that although reasonable efforts have been taken to ensure the accuracy and reliability of the Data Set, UTAH and the STUDY investigators do not and cannot warrant the research results or conclusions that may be obtained by using any data included therein. All contributors to the Data Set disclaim all warranties as to performance or fitness of the Data Set for any particular purpose.

XI. Termination and Violations

  1. UTAH may terminate this Agreement if RECIPIENT is in default of any terms and conditions of this Agreement and such default has not been remedied within 10 days after the date of written notice of such default. UTAH may unilaterally terminate this Agreement for any reason within 90 days written notice to RECIPIENT.
  2. Upon termination of this Agreement for any reason, RECIPIENT shall destroy any copies of Data Set in its possession, including derivative datasets that contain individual-level information, and shall document and report such destruction to UTAH.

XII. Amendments

  1. Amendments to this Agreement must be made in writing and signed by authorized representatives of all parties.

Request Form

Execution of the Agreement:

By entering the required information below and clicking “Agree”, the RECIPIENT certifies their agreement to adhere to the principles, policies and procedures for use of the Data Set as articulated in this Agreement.

Predicting Cervical Spine Injury (CSI) in Children: A Multi-Centered Case-Control Analysis

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  • Study Period: January 2000 - December 2004
  • Study Type: Retrospective Chart Abstraction
  • Study Enrollment: 3314

Purpose

540 Cases, 2774 Controls

The purpose of this study was to identify a set of variables that separate injured children with negligible risk of CSI from those at non-negligible risk for CSI, and to describe CSI in children. We conducted a retrospective case-control study of children with CSI by abstracting information from medical records about clinical findings, mechanism-of-injury factors, previous medical history, interventions performed, imaging obtained, and outcomes. Three controls groups were identified: (1) children seen at the same hospital within a year of the matched case, (2) children additionally matched by age and mechanism of injury, and (3) children transported to the hospital by EMS additionally matched to EMS transported cases by age.

Data collection was performed at 17 PECARN hospitals, which collectively screened 2,395 cases and 6,764 controls for eligibility. The study identified 540 cases, 1,060 unmatched (random) controls, 1,012 mechanism-of-injury and age matched (MOI) controls, and 702 age-matched EMS (EMS) controls for analyses.

I. Introduction and Definitions

  1. Predicting Cervical Spine Injury (CSI) in Children: A Multi-Centered Case-Control Analysis (the “STUDY”) Public Use Data Set (the “Data Set”) has been prepared by staff at the Data Coordinating Center, University of Utah School of Medicine (“UTAH”), on behalf of the Pediatric Emergency Care Applied Research Network (PECARN). In exchange for the ability to use the Data Set, the RECIPIENT agrees to comply with this Research Data Use Agreement (“Agreement”). The purpose of this availability is to provide the Data Set to investigators who wish to analyze the data in a secondary study designed to enhance the public health benefit of the original work.
  2. The RECIPIENT acknowledges its responsibility for ensuring adherence to the terms of this Agreement, subject to applicable Federal and State laws and regulations, including the privacy and security provisions of HIPAA and HITECH.
  3. The Data Set meets the definition of a De-identified Data Set as defined in 45 CFR Section 164.514(b).

II. Data Set Description and Support

  1. The Data Set will be provided as SAS datasets or CSV text files suitable for importation in statistical software. Electronic copies of the data worksheets, the final STUDY protocol, and a data dictionary will also be provided. No further support whatsoever will be provided by UTAH, STUDY investigators, PECARN or Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC) to the RECIPIENT.

III. Approved Research Uses

  1. The RECIPIENT agrees that it will use the Data Set solely in connection with a research project which will be completed in compliance with the terms of this Agreement.

IV. Non-Identification of Subjects

  1. The RECIPIENT agrees that it will not attempt to identify or contact the subjects or institutions that are included in the Data Set.

V. Non-Transferability of Data/Security of Data

  1. The RECIPIENT agrees to maintain control over the Data Set and further agrees not to release or distribute the Data Set in any form to any entity or individual for any purpose except as may be required by law or as permitted by this Agreement. If multiple individuals are collaborating and it is necessary to share the Data Set, each individual who will have a copy of the Data Set must execute a separate Agreement with UTAH.
  2. RECIPIENT agrees to use appropriate safeguards to ensure that Data Set is not used or disclosed in a manner inconsistent with this Agreement. RECIPIENT agrees to immediately report to UTAH any use or disclosure of the Data Set not in compliance with this Agreement and to provide all reasonable information requested by UTAH related to such use or disclosure.
  3. With respect to the Data Set, RECIPIENT agrees to comply with the security and privacy standards for Electronic Protected Health Information as defined in 45 CFR parts 160 and 164, Subpart C, as may be amended thereafter; RECIPIENT also agrees to comply with the Health Information Technology for Economic and Clinical Health (HITECH) Act effective February 17, 2009, and its implementing regulations.

VI. Duration of Agreement

  1. This RDUA will be in effect for a period of three (3) years from its effective date for the requested Data Set. The RDUA may be extended upon execution of a new RDUA document. At the end of the three (3) year period or extension, if another new extension is not in place, the RECIPIENT agrees to destroy all copies of the Data Set, including derivative datasets that contain individual-level information.

VII. Acknowledgment of Data Resource

  1. The RECIPIENT agrees to acknowledge the contribution of the STUDY in all oral and written presentations, disclosures, or publications resulting from any analyses conducted on the Data Set.
  2. The source of the Data Set will be acknowledged by including language similar to the following either in the acknowledgement or in the text of the manuscript: “This manuscript was prepared using the Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study (STUDY) Data Set obtained from UTAH, and does not necessarily reflect the opinions or views of the STUDY investigators or the Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC). The PECARN was funded by the HRSA/MCHB/EMSC.” Manuscripts and meeting abstracts may not use the name of the STUDY in the title, nor may the name of the STUDY or PECARN be included in the byline of the publication.

VIII. Publication

  1. The RECIPIENT agrees to provide to UTAH a copy of any manuscript thirty (30) days in advance of submission for publication, in order to ensure compliance with the terms of this Agreement. In addition, UTAH may in its discretion forward the manuscript to STUDY investigators for comment. If STUDY investigators choose to offer additional comments, these are provided only as courtesy. The RECIPIENT is not obligated to incorporate additional comments from STUDY investigators; however, these comments may provide the RECIPIENT with additional insights towards improving the manuscript.

IX. Duplication of Research

  1. The RECIPIENT acknowledges that other researchers are entitled to access to the Data Set on the same terms as RECIPIENT, and duplication of the RECIPIENT’s research may occur.

X. Non-Endorsement

  1. The RECIPIENT acknowledges that although reasonable efforts have been taken to ensure the accuracy and reliability of the Data Set, UTAH and the STUDY investigators do not and cannot warrant the research results or conclusions that may be obtained by using any data included therein. All contributors to the Data Set disclaim all warranties as to performance or fitness of the Data Set for any particular purpose.

XI. Termination and Violations

  1. UTAH may terminate this Agreement if RECIPIENT is in default of any terms and conditions of this Agreement and such default has not been remedied within 10 days after the date of written notice of such default. UTAH may unilaterally terminate this Agreement for any reason within 90 days written notice to RECIPIENT.
  2. Upon termination of this Agreement for any reason, RECIPIENT shall destroy any copies of Data Set in its possession, including derivative datasets that contain individual-level information, and shall document and report such destruction to UTAH.

XII. Amendments

  1. Amendments to this Agreement must be made in writing and signed by authorized representatives of all parties.

Request Form

Execution of the Agreement:

By entering the required information below and clicking “Agree”, the RECIPIENT certifies their agreement to adhere to the principles, policies and procedures for use of the Data Set as articulated in this Agreement.

RNA Biosignatures: A Paradigm Change for the Management of Young Febrile Infants

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  • Study Period: November 2015 - December 2019
  • Study Type: Observational
  • Study Design: This is a prospective, multi-center, cross-sectional study of febrile infants ≤ 60 days of age who are being evaluated for bacterial infections in Pediatric Emergency Care Applied Research Network (PECARN) emergency departments (ED). In order to have sufficient events (bacterial infections), up to 2,800 infants will be accrued over a four to five-year period.
  • Study Enrollment: 2612
  • Consent: Yes

Purpose

The study investigators have identified novel and distinct RNA expression patterns (RNA biosignatures) in febrile infants ≤ 60 days of age. This proof of concept work has demonstrated well-defined RNA biosignatures in infants with bacterial and non-bacterial infections. Febrile infants with bacterial infections have distinct RNA gene expression patterns characterized by over-expression of inflammatory genes, while interferon genes are consistently over-expressed in febrile infants with- out bacterial infections. This previous work has identified 66 classifier genes that discriminate febrile infants with bacterial infections with 87% accuracy, suggesting a potentially more accurate reference than microbiologic cultures.

The long-term objective of this research protocol is to investigate whole genome RNA expression profiles to define RNA biosignatures that allow precise diagnosis of isolated bacterial infections, isolated viral infections and bacterial-viral co-infections in febrile infants ≤ 60 days of age. Addressing the optimal evaluation and management of the febrile infant will assure that this vulnerable population of children have the chance to achieve their full potential for healthy and productive lives, free from disease or disability.

I. Introduction and Definitions

  1. RNA Biosignatures: A Paradigm Change for the Management of Young Febrile Infants (the “STUDY”) Public Use Data Set (the “Data Set”) has been prepared by staff at the Data Coordinating Center, University of Utah School of Medicine (“UTAH”), on behalf of the Pediatric Emergency Care Applied Research Network (PECARN). In exchange for the ability to use the Data Set, the RECIPIENT agrees to comply with this Research Data Use Agreement (“Agreement”). The purpose of this availability is to provide the Data Set to investigators who wish to analyze the data in a secondary study designed to enhance the public health benefit of the original work.
  2. The RECIPIENT acknowledges its responsibility for ensuring adherence to the terms of this Agreement, subject to applicable Federal and State laws and regulations, including the privacy and security provisions of HIPAA and HITECH.
  3. The Data Set meets the definition of a De-identified Data Set as defined in 45 CFR Section 164.514(b).

II. Data Set Description and Support

  1. The Data Set will be provided as SAS datasets or CSV text files suitable for importation in statistical software. Electronic copies of the data worksheets, the final STUDY protocol, and a data dictionary will also be provided. No further support whatsoever will be provided by UTAH, STUDY investigators, PECARN or Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC) to the RECIPIENT.

III. Approved Research Uses

  1. The RECIPIENT agrees that it will use the Data Set solely in connection with a research project which will be completed in compliance with the terms of this Agreement.

IV. Non-Identification of Subjects

  1. The RECIPIENT agrees that it will not attempt to identify or contact the subjects or institutions that are included in the Data Set.

V. Non-Transferability of Data/Security of Data

  1. The RECIPIENT agrees to maintain control over the Data Set and further agrees not to release or distribute the Data Set in any form to any entity or individual for any purpose except as may be required by law or as permitted by this Agreement. If multiple individuals are collaborating and it is necessary to share the Data Set, each individual who will have a copy of the Data Set must execute a separate Agreement with UTAH.
  2. RECIPIENT agrees to use appropriate safeguards to ensure that Data Set is not used or disclosed in a manner inconsistent with this Agreement. RECIPIENT agrees to immediately report to UTAH any use or disclosure of the Data Set not in compliance with this Agreement and to provide all reasonable information requested by UTAH related to such use or disclosure.
  3. With respect to the Data Set, RECIPIENT agrees to comply with the security and privacy standards for Electronic Protected Health Information as defined in 45 CFR parts 160 and 164, Subpart C, as may be amended thereafter; RECIPIENT also agrees to comply with the Health Information Technology for Economic and Clinical Health (HITECH) Act effective February 17, 2009, and its implementing regulations.

VI. Duration of Agreement

  1. This RDUA will be in effect for a period of three (3) years from its effective date for the requested Data Set. The RDUA may be extended upon execution of a new RDUA document. At the end of the three (3) year period or extension, if another new extension is not in place, the RECIPIENT agrees to destroy all copies of the Data Set, including derivative datasets that contain individual-level information.

VII. Acknowledgment of Data Resource

  1. The RECIPIENT agrees to acknowledge the contribution of the STUDY in all oral and written presentations, disclosures, or publications resulting from any analyses conducted on the Data Set.
  2. The source of the Data Set will be acknowledged by including language similar to the following either in the acknowledgement or in the text of the manuscript: “This manuscript was prepared using the Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study (STUDY) Data Set obtained from UTAH, and does not necessarily reflect the opinions or views of the STUDY investigators or the Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC). The PECARN was funded by the HRSA/MCHB/EMSC.” Manuscripts and meeting abstracts may not use the name of the STUDY in the title, nor may the name of the STUDY or PECARN be included in the byline of the publication.

VIII. Publication

  1. The RECIPIENT agrees to provide to UTAH a copy of any manuscript thirty (30) days in advance of submission for publication, in order to ensure compliance with the terms of this Agreement. In addition, UTAH may in its discretion forward the manuscript to STUDY investigators for comment. If STUDY investigators choose to offer additional comments, these are provided only as courtesy. The RECIPIENT is not obligated to incorporate additional comments from STUDY investigators; however, these comments may provide the RECIPIENT with additional insights towards improving the manuscript.

IX. Duplication of Research

  1. The RECIPIENT acknowledges that other researchers are entitled to access to the Data Set on the same terms as RECIPIENT, and duplication of the RECIPIENT’s research may occur.

X. Non-Endorsement

  1. The RECIPIENT acknowledges that although reasonable efforts have been taken to ensure the accuracy and reliability of the Data Set, UTAH and the STUDY investigators do not and cannot warrant the research results or conclusions that may be obtained by using any data included therein. All contributors to the Data Set disclaim all warranties as to performance or fitness of the Data Set for any particular purpose.

XI. Termination and Violations

  1. UTAH may terminate this Agreement if RECIPIENT is in default of any terms and conditions of this Agreement and such default has not been remedied within 10 days after the date of written notice of such default. UTAH may unilaterally terminate this Agreement for any reason within 90 days written notice to RECIPIENT.
  2. Upon termination of this Agreement for any reason, RECIPIENT shall destroy any copies of Data Set in its possession, including derivative datasets that contain individual-level information, and shall document and report such destruction to UTAH.

XII. Amendments

  1. Amendments to this Agreement must be made in writing and signed by authorized representatives of all parties.

Request Form

Execution of the Agreement:

By entering the required information below and clicking “Agree”, the RECIPIENT certifies their agreement to adhere to the principles, policies and procedures for use of the Data Set as articulated in this Agreement.

Teen Alcohol Screening in the Pediatric Emergency Care Applied Research Network (ASSESS) 

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  • Study Period: September 2012 - March 2018
  • Study Type: Observational
  • Consent: yes

Purpose

This was a multi-center study to test the concurrent, convergent and predictive validity of the NIAAA two-question screen using established, validated measurement instruments in youths 12-17 years old. The purpose of this study was to evaluate the ability of the NIAAA two-question screen to predict current and future alcohol and other drug (AOD) risks, as well as, other behavior problems. Patients were approached and consented in the emergency department to complete the two-question screen and an alcohol and other drug and behavior assessment battery. A subsample of participants (200) were re-administered the NIAAA two-question screen one week after their initial ED visit to assess the test-retest reliability of the NIAAA two-question screen. The second subsample (about 2225 participants), were reassessed yearly, every 3 years after their emergency department visit with the criterion assessment battery to assess the predictive validity of the two-question screen.

I. Introduction and Definitions

  1. Teen Alcohol Screening in the Pediatric Emergency Care Applied Research Network (ASSESS)  (the “STUDY”) Public Use Data Set (the “Data Set”) has been prepared by staff at the Data Coordinating Center, University of Utah School of Medicine (“UTAH”), on behalf of the Pediatric Emergency Care Applied Research Network (PECARN). In exchange for the ability to use the Data Set, the RECIPIENT agrees to comply with this Research Data Use Agreement (“Agreement”). The purpose of this availability is to provide the Data Set to investigators who wish to analyze the data in a secondary study designed to enhance the public health benefit of the original work.
  2. The RECIPIENT acknowledges its responsibility for ensuring adherence to the terms of this Agreement, subject to applicable Federal and State laws and regulations, including the privacy and security provisions of HIPAA and HITECH.
  3. The Data Set meets the definition of a De-identified Data Set as defined in 45 CFR Section 164.514(b).

II. Data Set Description and Support

  1. The Data Set will be provided as SAS datasets or CSV text files suitable for importation in statistical software. Electronic copies of the data worksheets, the final STUDY protocol, and a data dictionary will also be provided. No further support whatsoever will be provided by UTAH, STUDY investigators, PECARN or Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC) to the RECIPIENT.

III. Approved Research Uses

  1. The RECIPIENT agrees that it will use the Data Set solely in connection with a research project which will be completed in compliance with the terms of this Agreement.

IV. Non-Identification of Subjects

  1. The RECIPIENT agrees that it will not attempt to identify or contact the subjects or institutions that are included in the Data Set.

V. Non-Transferability of Data/Security of Data

  1. The RECIPIENT agrees to maintain control over the Data Set and further agrees not to release or distribute the Data Set in any form to any entity or individual for any purpose except as may be required by law or as permitted by this Agreement. If multiple individuals are collaborating and it is necessary to share the Data Set, each individual who will have a copy of the Data Set must execute a separate Agreement with UTAH.
  2. RECIPIENT agrees to use appropriate safeguards to ensure that Data Set is not used or disclosed in a manner inconsistent with this Agreement. RECIPIENT agrees to immediately report to UTAH any use or disclosure of the Data Set not in compliance with this Agreement and to provide all reasonable information requested by UTAH related to such use or disclosure.
  3. With respect to the Data Set, RECIPIENT agrees to comply with the security and privacy standards for Electronic Protected Health Information as defined in 45 CFR parts 160 and 164, Subpart C, as may be amended thereafter; RECIPIENT also agrees to comply with the Health Information Technology for Economic and Clinical Health (HITECH) Act effective February 17, 2009, and its implementing regulations.

VI. Duration of Agreement

  1. This RDUA will be in effect for a period of three (3) years from its effective date for the requested Data Set. The RDUA may be extended upon execution of a new RDUA document. At the end of the three (3) year period or extension, if another new extension is not in place, the RECIPIENT agrees to destroy all copies of the Data Set, including derivative datasets that contain individual-level information.

VII. Acknowledgment of Data Resource

  1. The RECIPIENT agrees to acknowledge the contribution of the STUDY in all oral and written presentations, disclosures, or publications resulting from any analyses conducted on the Data Set.
  2. The source of the Data Set will be acknowledged by including language similar to the following either in the acknowledgement or in the text of the manuscript: “This manuscript was prepared using the Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study (STUDY) Data Set obtained from UTAH, and does not necessarily reflect the opinions or views of the STUDY investigators or the Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC). The PECARN was funded by the HRSA/MCHB/EMSC.” Manuscripts and meeting abstracts may not use the name of the STUDY in the title, nor may the name of the STUDY or PECARN be included in the byline of the publication.

VIII. Publication

  1. The RECIPIENT agrees to provide to UTAH a copy of any manuscript thirty (30) days in advance of submission for publication, in order to ensure compliance with the terms of this Agreement. In addition, UTAH may in its discretion forward the manuscript to STUDY investigators for comment. If STUDY investigators choose to offer additional comments, these are provided only as courtesy. The RECIPIENT is not obligated to incorporate additional comments from STUDY investigators; however, these comments may provide the RECIPIENT with additional insights towards improving the manuscript.

IX. Duplication of Research

  1. The RECIPIENT acknowledges that other researchers are entitled to access to the Data Set on the same terms as RECIPIENT, and duplication of the RECIPIENT’s research may occur.

X. Non-Endorsement

  1. The RECIPIENT acknowledges that although reasonable efforts have been taken to ensure the accuracy and reliability of the Data Set, UTAH and the STUDY investigators do not and cannot warrant the research results or conclusions that may be obtained by using any data included therein. All contributors to the Data Set disclaim all warranties as to performance or fitness of the Data Set for any particular purpose.

XI. Termination and Violations

  1. UTAH may terminate this Agreement if RECIPIENT is in default of any terms and conditions of this Agreement and such default has not been remedied within 10 days after the date of written notice of such default. UTAH may unilaterally terminate this Agreement for any reason within 90 days written notice to RECIPIENT.
  2. Upon termination of this Agreement for any reason, RECIPIENT shall destroy any copies of Data Set in its possession, including derivative datasets that contain individual-level information, and shall document and report such destruction to UTAH.

XII. Amendments

  1. Amendments to this Agreement must be made in writing and signed by authorized representatives of all parties.

Request Form

Execution of the Agreement:

By entering the required information below and clicking “Agree”, the RECIPIENT certifies their agreement to adhere to the principles, policies and procedures for use of the Data Set as articulated in this Agreement.

The Effectiveness of Oral Dexamethasone for Acute Bronchiolitis: A Multicenter Randomized Controlled Trial

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  • Study Period: January 2004 - April 2006
  • Study Type: Interventional
  • Study Enrollment: 598
  • Consent: Yes

Purpose

This study compared a single dose of oral dexamethasone to placebo in a multicenter, randomized, double blind trial of infants aged 2 to 12 months with first-time bronchiolitis (defined as wheezing within 7 days of onset). This is given as additional therapy beyond any other routine therapy used at that center. No current standard therapy is withheld, and no additional tests or other treatments are part of the study. The primary hypothesis was that dexamethasone would be more effective than placebo in preventing hospital admission. The secondary hypotheses were that dexamethasone would decrease respiratory scores and possibly the duration of the disease when compared to placebo, and that dexamethasone would be as safe and as well tolerated as placebo.

I. Introduction and Definitions

  1. The Effectiveness of Oral Dexamethasone for Acute Bronchiolitis: A Multicenter Randomized Controlled Trial (the “STUDY”) Public Use Data Set (the “Data Set”) has been prepared by staff at the Data Coordinating Center, University of Utah School of Medicine (“UTAH”), on behalf of the Pediatric Emergency Care Applied Research Network (PECARN). In exchange for the ability to use the Data Set, the RECIPIENT agrees to comply with this Research Data Use Agreement (“Agreement”). The purpose of this availability is to provide the Data Set to investigators who wish to analyze the data in a secondary study designed to enhance the public health benefit of the original work.
  2. The RECIPIENT acknowledges its responsibility for ensuring adherence to the terms of this Agreement, subject to applicable Federal and State laws and regulations, including the privacy and security provisions of HIPAA and HITECH.
  3. The Data Set meets the definition of a De-identified Data Set as defined in 45 CFR Section 164.514(b).

II. Data Set Description and Support

  1. The Data Set will be provided as SAS datasets or CSV text files suitable for importation in statistical software. Electronic copies of the data worksheets, the final STUDY protocol, and a data dictionary will also be provided. No further support whatsoever will be provided by UTAH, STUDY investigators, PECARN or Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC) to the RECIPIENT.

III. Approved Research Uses

  1. The RECIPIENT agrees that it will use the Data Set solely in connection with a research project which will be completed in compliance with the terms of this Agreement.

IV. Non-Identification of Subjects

  1. The RECIPIENT agrees that it will not attempt to identify or contact the subjects or institutions that are included in the Data Set.

V. Non-Transferability of Data/Security of Data

  1. The RECIPIENT agrees to maintain control over the Data Set and further agrees not to release or distribute the Data Set in any form to any entity or individual for any purpose except as may be required by law or as permitted by this Agreement. If multiple individuals are collaborating and it is necessary to share the Data Set, each individual who will have a copy of the Data Set must execute a separate Agreement with UTAH.
  2. RECIPIENT agrees to use appropriate safeguards to ensure that Data Set is not used or disclosed in a manner inconsistent with this Agreement. RECIPIENT agrees to immediately report to UTAH any use or disclosure of the Data Set not in compliance with this Agreement and to provide all reasonable information requested by UTAH related to such use or disclosure.
  3. With respect to the Data Set, RECIPIENT agrees to comply with the security and privacy standards for Electronic Protected Health Information as defined in 45 CFR parts 160 and 164, Subpart C, as may be amended thereafter; RECIPIENT also agrees to comply with the Health Information Technology for Economic and Clinical Health (HITECH) Act effective February 17, 2009, and its implementing regulations.

VI. Duration of Agreement

  1. This RDUA will be in effect for a period of three (3) years from its effective date for the requested Data Set. The RDUA may be extended upon execution of a new RDUA document. At the end of the three (3) year period or extension, if another new extension is not in place, the RECIPIENT agrees to destroy all copies of the Data Set, including derivative datasets that contain individual-level information.

VII. Acknowledgment of Data Resource

  1. The RECIPIENT agrees to acknowledge the contribution of the STUDY in all oral and written presentations, disclosures, or publications resulting from any analyses conducted on the Data Set.
  2. The source of the Data Set will be acknowledged by including language similar to the following either in the acknowledgement or in the text of the manuscript: “This manuscript was prepared using the Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study (STUDY) Data Set obtained from UTAH, and does not necessarily reflect the opinions or views of the STUDY investigators or the Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC). The PECARN was funded by the HRSA/MCHB/EMSC.” Manuscripts and meeting abstracts may not use the name of the STUDY in the title, nor may the name of the STUDY or PECARN be included in the byline of the publication.

VIII. Publication

  1. The RECIPIENT agrees to provide to UTAH a copy of any manuscript thirty (30) days in advance of submission for publication, in order to ensure compliance with the terms of this Agreement. In addition, UTAH may in its discretion forward the manuscript to STUDY investigators for comment. If STUDY investigators choose to offer additional comments, these are provided only as courtesy. The RECIPIENT is not obligated to incorporate additional comments from STUDY investigators; however, these comments may provide the RECIPIENT with additional insights towards improving the manuscript.

IX. Duplication of Research

  1. The RECIPIENT acknowledges that other researchers are entitled to access to the Data Set on the same terms as RECIPIENT, and duplication of the RECIPIENT’s research may occur.

X. Non-Endorsement

  1. The RECIPIENT acknowledges that although reasonable efforts have been taken to ensure the accuracy and reliability of the Data Set, UTAH and the STUDY investigators do not and cannot warrant the research results or conclusions that may be obtained by using any data included therein. All contributors to the Data Set disclaim all warranties as to performance or fitness of the Data Set for any particular purpose.

XI. Termination and Violations

  1. UTAH may terminate this Agreement if RECIPIENT is in default of any terms and conditions of this Agreement and such default has not been remedied within 10 days after the date of written notice of such default. UTAH may unilaterally terminate this Agreement for any reason within 90 days written notice to RECIPIENT.
  2. Upon termination of this Agreement for any reason, RECIPIENT shall destroy any copies of Data Set in its possession, including derivative datasets that contain individual-level information, and shall document and report such destruction to UTAH.

XII. Amendments

  1. Amendments to this Agreement must be made in writing and signed by authorized representatives of all parties.

Request Form

Execution of the Agreement:

By entering the required information below and clicking “Agree”, the RECIPIENT certifies their agreement to adhere to the principles, policies and procedures for use of the Data Set as articulated in this Agreement.

This website is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) as part of the Emergency Medical Services for Children Data Center award totaling $3,200,000 with 0% financed with non-governmental sources. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by HRSA, HHS, or the U.S. Government. For more information, please visit HRSA.gov.