What documentation identifies the IRB/IEC review and approval and notes the version number and date of documents?

• A. Dated, Documented Approval/Favorable Opinion of IRB/IEC
• B. IRB/IEC Composition
• C. Regulatory Authorities Authorization/Approval/Notification of Protocol
• D. Curriculum Vitae and/or Other Relevant Documents Evidencing Qualifications of Investigators and Sub-Investigators

Answer: (A)

Ethics approval is evidenced by a dated, formal approval or favorable opinion from the IRB/IEC that specifies exactly which documents were approved and notes their version numbers and dates. This document provides the official record that the ethics review occurred, who approved it, and which version of the protocol and consent forms (and other key documents) were approved for use. It ensures you can verify that participants were enrolled under the currently approved documents and that all submissions reflect the approved versions.

The other options don’t fit because the composition of the IRB/IEC only describes whoReviewer members are, not the approval decision or document versions. Regulatory authorities’ authorization relates to outside oversight and may confirm compliance but doesn’t replace the IRB’s own approval notice with document version details. Curriculum vitae and similar docs show investigator qualifications, not ethical review status.