What are They and When do They Need to be Submitted to the IRB?

Provided By:

WCG IRB

September 1, 2021

Changes in Research (CIRs) come in various forms: protocol amendments, administrative letters, notes to file, safety reports, study committee reports, recruitment plans and unanticipated problems. In this whitepaper we discuss how to assess whether an event meets the guidelines for being promptly reportable to the IRB.

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