ICMJE Data Sharing Statement Guidance
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
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.