CIRs: What are they and when do they need to be submitted to the IRB?

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.



Field will not be visible to web visitor

Copyright 2022 Industry Dive | Privacy Policy | Terms of Use