Clinical Data Request Process: IRB Checklist

Please use the checklist below as a guide for verifying that an Institutional Review Board (IRB) protocol approval is sufficient for limited and identified research data extraction requests.


Grant Key Personnel Access to the Study Section

  • Is the Principal Investigator listed on the request form listed as a PI for the study in the protocol application?
  • Are the study team members to whom the data set will be delivered listed as study personnel for the study in the protocol application?

Sites Section

  • Verify that all sites from which the client is seeking data are selected.

Confidentiality & Privacy Section

  • Are the identified data elements being requested selected in this section?
  • Are any special conditions outlined in this section that impact our ability to provide the requested data set to the requested study team members?

Recruitment Section

  • Is this section completed for any requested contact information data elements?

Scientific Considerations Section

  • Are the study aims outlined in the protocol application consistent with the aims of the data extraction request?

Approval Letter

  • Does the study have an active approval?
  • Ensure that the protocol approval will not expire prior to the delivery of the requested data set.

Sample Size & Eligibility Section

  • Is the specified sample size consistent with the cohort size contained in the data extraction deliverables?
  • Are the specified inclusion and exclusion criteria consistent with the requested inclusion and exclusion criteria of the data extraction?

Subjects Section

  • Ensure that any protected populations for which data is being requested are specified in this section.