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Open Access

Launch of the National Trauma Research Repository coincides with new data sharing requirements

Michelle A Price, Pam J Bixby, Monica J Phillips, Gregory J Beilman, Eileen M Bulger, Michael R Davis, Matthew J McAuliffe, Todd E Rasmussen, Jose Salinas, Sharon L Smith, Mary Ann Spott, Leonard J Weireter, Donald H Jenkins
DOI: 10.1136/tsaco-2018-000193 Published 27 June 2018
Michelle A Price
1 National Trauma Institute, San Antonio, Texas, USA
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Pam J Bixby
1 National Trauma Institute, San Antonio, Texas, USA
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Monica J Phillips
1 National Trauma Institute, San Antonio, Texas, USA
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Gregory J Beilman
2 Department of Surgery, University of Minnesota, Minneapolis, Minnesota, USA
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Eileen M Bulger
3 Department of Surgery, University of Washington, Seattle, Washington, USA
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Michael R Davis
4 US Combat Casualty Care Research Program, US Army Medical Research and Materiel Command, Ft Detrick, Maryland, USA
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Matthew J McAuliffe
5 Center for Information Technology, National Institutes of Health, Bethesda, Maryland, USA
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Todd E Rasmussen
6 F Edward Hébert School of Medicine, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA
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Jose Salinas
7 Clinical Decision Support and Automation Research, US Army Institute of Surgical Research, JBSA Fort Sam Houston, San Antonio, Texas, USA
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Sharon L Smith
1 National Trauma Institute, San Antonio, Texas, USA
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Mary Ann Spott
8 Joint Trauma System, JBSA Fort Sam Houston, San Antonio, Texas, USA
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Leonard J Weireter
9 Department of Surgery, Eastern Virginia Medical School, Norfolk, Virginia, USA
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Donald H Jenkins
10 Department of Surgery, University of Texas Health – San Antonio, San Antonio, Texas, USA
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Article Figures & Data

Tables

  • Table 1

    Examples of data sharing statements that fulfill the ICMJE requirements

    Example 1Example 2Example 3Example 4
    Will individual participant data be available (including data dictionaries)?Yes.Yes.Yes.No.
    What data in particular will be shared?All of the individual participant data collected during the trial, after deidentification.Individual participant data that underlie the results reported in this article after deidentification (text, tables, figures, and appendices).Individual participant data that underlie the results reported in this article after deidentification (text, tables, figures, and appendices).Not available.
    What other documents will be available?Study protocol, statistical analysis plan, informed consent form, clinical study report, analytic code.Study protocol, statistical analysis plan, analytic code.Study protocol.Not available.
    When will data be available (start and end dates)?Immediately after publication—no end date.Beginning 3 months and ending 5 years after article publication.Beginning 9 months and ending 36 months after article publication.Not applicable.
    With whom will the data be shared?Anyone who wishes to access the data.Researchers who provide a methodologically sound proposal.Investigators whose proposed use of the data has been approved by an independent review committee (learned intermediary) identified for this purpose.Not applicable.
    What types of analyses are authorized to be conducted?Any purpose.To achieve aims in the approved proposal.For individual participant data meta-analysis.Not applicable.
    By what mechanism will data be made available?Data are available indefinitely at (include link).Proposals should be directed to xxx@yyy. To gain access, data requesters will need to sign a data access agreement. Data are available for 5 years at (include link).Proposals may be submitted up to 36 months after article publication. After 36 months the data will be available in our university’s data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data is at (include link).
    • ICMJE, International Committee of Medical Journal Editors.

    • a Reprinted with permission from the Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals at http://www.icmje.org/icmje-recommendations.pdf.13

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Launch of the National Trauma Research Repository coincides with new data sharing requirements
Michelle A Price, Pam J Bixby, Monica J Phillips, Gregory J Beilman, Eileen M Bulger, Michael R Davis, Matthew J McAuliffe, Todd E Rasmussen, Jose Salinas, Sharon L Smith, Mary Ann Spott, Leonard J Weireter, Donald H Jenkins
Trauma Surg Acute Care Open Jun 2018, 3 (1) e000193; DOI: 10.1136/tsaco-2018-000193

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Launch of the National Trauma Research Repository coincides with new data sharing requirements
Michelle A Price, Pam J Bixby, Monica J Phillips, Gregory J Beilman, Eileen M Bulger, Michael R Davis, Matthew J McAuliffe, Todd E Rasmussen, Jose Salinas, Sharon L Smith, Mary Ann Spott, Leonard J Weireter, Donald H Jenkins
Trauma Surg Acute Care Open Jun 2018, 3 (1) e000193; DOI: 10.1136/tsaco-2018-000193
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Launch of the National Trauma Research Repository coincides with new data sharing requirements
Michelle A Price, Pam J Bixby, Monica J Phillips, Gregory J Beilman, Eileen M Bulger, Michael R Davis, Matthew J McAuliffe, Todd E Rasmussen, Jose Salinas, Sharon L Smith, Mary Ann Spott, Leonard J Weireter, Donald H Jenkins
Trauma Surgery & Acute Care Open Jun 2018, 3 (1) e000193; DOI: 10.1136/tsaco-2018-000193
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