In GCP, the plan for compensating trial-related injuries must be documented in two places: at the Investigator/Institution and with the Sponsor. This dual documentation ensures the participant is informed about compensation before enrolling, and that both the site and the sponsor have verifiable records of the commitment. The informed consent form should state that compensation is available, and the sponsor should keep evidence of the coverage or insurance. Having documentation in both locations provides clear accountability and a ready path for claims; relying on a single location could create gaps in how compensation is accessed or verified.

Regulatory authorization must be obtained before starting a trial. The sponsor submits the required written applications for review, acceptance, and permission to begin the study, and these submissions must be dated and identifiable so authorities can track and approve the trial. Verbal notices aren’t sufficient, final results aren’t available until after completion, and while consent forms are essential documents, they aren’t the formal submission used to grant permission to initiate the trial.

The key idea is ensuring that unused Investigational Product (IP) is handled in a controlled, auditable way that meets regulatory requirements. In a sponsor’s IP disposition system, every unused item must be accounted for and disposed of or redirected in a manner that is legally compliant and traceable. This means there’s a documented plan for what to do with the IP (return to sponsor, destruction, or another approved disposition), and the method chosen must conform to applicable laws and guidelines. The system records essential details—dates, quantities, lot numbers, reasons for disposal, the chosen disposition method, and who authorized and witnessed the action—and keeps clear records for audits or inspections. This ensures there’s no unaccounted IP and that patient safety, data integrity, and regulatory compliance are maintained. Disposing without documentation or requiring consent as the sole condition would leave the IP untraceable and noncompliant, and doing nothing with IP isn’t appropriate once it’s unused.

IRB/IEC oversight relies on the investigator keeping the board informed with every document that could affect participant protection or how the study is conducted. Throughout a trial, new information frequently emerges—protocol amendments, updated consent forms, serious adverse events, annual progress reports, and any other data that could change risk/benefit or how participants understand what they’re agreeing to. The IRB/IEC reviews these items to decide whether ongoing approval is appropriate and whether informed consent remains valid. Therefore, the investigator should provide all documents subject to review, not just a subset. Offering only the initial protocol or only one type of document would leave the board without the full context needed to protect subjects and ensure regulatory compliance.