Tip of the Week Archive

Very Bad IPD Sharing Statement:

• Plan to Share IPD: “Undecided”

  ICMJE data sharing recommendations state that “Undecided” is not an acceptable response for publication. If a plan is not yet in place, select “No” and change it later if you decide to share IPD.

   

  Bad IPD Sharing Statement:

• Plan to Share IPD: “Yes”
• Plan Description: “No individual participant data will be shared. Results will be published by the investigators in academic journals. Sharing of generated study data will be carried out in several different ways. We plan to make our results available to researchers and potential collaborators interested in sickle cell anemia.”

   

  The Plan to Share IPD element is “Yes”, but the plan description starts with “No IPD will be shared.” Aggregate data sharing (i.e. publication) should also not be included in the plan description.  Finally, the plan does not provide a time frame for when or how long the data will be made available, or how to request access.

   

  Okay IPD Sharing Statement:

• Plan to Share IPD: “Yes”
• Plan Description: “Data obtained through this study may be provided to qualified researchers with academic interest in sickle cell anemia. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.

   

  To make this a Good Sharing Statement, the record owner could add the following details:

• Time Frame: “Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.”
• Access Criteria: ““Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact clinicalresearchsupportcenter@ucdenver.edu.”

These tips were adapted from slides by Leah Silbert, Sr. Research Compliance Analyst at Cedars-Sinai Hospital, provided to the ClinicalTrials.gov Task Force on 3/21/2019.