Which documents should the IRB/IEC obtain from the investigator?

• A. The following: trial protocols/amendments, written informed consent forms and consent form updates, subject recruitment procedures, written information to be provided to subjects, Investigator's Brochure, available safety information, information about payments and compensation to subjects, the investigator's current curriculum vitae and/or other documentation evidencing qualifications, and any other documents necessary to fulfill its responsibilities.
• B. Only trial protocols.
• C. Only informed consent forms.
• D. Only safety information.

Answer: (A)

IRB/IEC oversight requires a complete dossier from the investigator to properly evaluate risk, protect subjects, and ensure regulatory compliance. Therefore, the IRB/IEC should obtain a comprehensive set of documents that covers every aspect of the study.

This includes the trial protocol and any amendments, which lay out the study design, objectives, and procedures; the informed consent forms and any updates, to confirm that participants are being asked to consent based on accurate information; recruitment procedures and the information provided to subjects, to show how subjects are identified and what they will be told; the Investigator’s Brochure and other safety information, to inform risk assessment and monitoring; details about payments and compensation to subjects, to address potential undue influence; the investigator’s current curriculum vitae or other evidence of qualifications, to ensure the investigator is capable of conducting the study; and any other documents needed to fulfill the IRB/IEC’s responsibilities.

Having this full set allows the IRB/IEC to assess that the study design minimizes risk, that consent is truly informed, that subject safety is monitored, and that the investigator is appropriately qualified. Providing only one subset—such as just the protocol, or just the consent forms, or just the safety information—would leave gaps in oversight and could compromise subject protection.