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Guidance on ICMJE Data Sharing Statements for Investigator-Initiated Research

Studies initiated after January 2019 require an IPD Sharing Statement in the designated section (i.e., “IPD Sharing Statement”) of the ClinicalTrials.gov registration record. The applicable sharing plan should be indicated. It is important to note that the ICMJE does not recognize “Undecided” as a valid response, although it is still available as an option. If you are uncertain about your sharing plans, you should select “No.”

Required Data Sharing Statement Elements

  • Whether individual deidentified data will be shared
  • What data will be shared
  • Availability of related documents (e.g., study protocol, statistical analysis plan)
  • When the data will be available and for how long
  • Criteria for obtaining the data

UNC Data Sharing Statement

The following statement is provided by Office of University Counsel:Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

When data sharing is permitted, a Data Use Agreement (DUA) specifying the uses of such data to be shared must be in place before any data is shared. Requests can be submitted to the Industry Contracting for processing. The Principal Investigator must confirm that the DUA has been fully executed and IRB, IEC, or REB approval has been granted before sharing data. For further information on DUAs, please refer to the Data Use Agreement Guidance.