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.
Checklist
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.