Considerations When Transfering Clinical Investigation Oversight to Another irb

(2) Ensuring the availability and retention of pertinent records. 

 

Before the receiving IRB accepts oversight of the transferred clinical investigation, it should 

obtain copies of pertinent records to allow it to meet its review and ongoing oversight 

responsibilities for the study once transferred.

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 Pertinent records include documents such as the 

research protocol and significant amendments; approved consent form; investigator’s brochure; 

minutes of IRB meetings at which the research was reviewed; reports of unanticipated problems 

involving risk to human subjects and others; reports of IRB-conducted audits, if any; and 

correspondence with the investigator, sponsor, and/or FDA.