During the trial, to whom should the investigator provide documents subject to review?

• A. IRB/IEC.
• B. Sponsor.
• C. Regulatory authority only.
• D. Trial participants.

Answer: (A)

In GCP, the IRB/IEC is the body responsible for ethical review and ongoing oversight of the trial to protect participants’ rights and welfare. Because of that role, investigators must provide documents that are subject to review to the IRB/IEC so they can assess safety, consent processes, and compliance with the protocol. This includes things like the protocol, informed consent forms, consent/assent documents, any amendments, continuing review reports, and safety or adverse event summaries as requested.

While sponsors may need access to certain trial documents for monitoring and regulatory submissions, and regulatory authorities may inspect records, the primary recipient for documents that require formal review is the IRB/IEC. Trial participants receive information through approved consent materials and ongoing communications, not the full set of study documents.