According to regulation, what must an investigator keep records of?

One of the primary responsibilities of an investigator in a clinical trial is to maintain comprehensive and accurate records as mandated by regulatory requirements. This includes keeping track of the disposition of the study drug and signed informed consent forms (ICFs).

The disposition of the study drug is crucial as it ensures that the investigational product is accounted for, documenting how much was received, used, returned, or destroyed. This aspect is vital for ensuring compliance with the protocol and regulatory standards, as it helps confirm that the study drug was managed properly and that participants were treated according to the study design.

Additionally, signed informed consent forms are essential as they serve to protect the rights and welfare of study participants. These documents indicate that participants have been adequately informed about the trial, including potential risks and benefits, and have voluntarily agreed to participate. Proper documentation of consent is not only a regulatory requirement but also a fundamental ethical obligation in clinical research.

Maintaining both of these records is critical to uphold the integrity of the study, facilitate audits and inspections, and ensure accountability throughout the research process. This comprehensive approach to record-keeping aligns with best practices in clinical research, underscoring the importance of meticulous documentation to safeguard participant rights and ensure the validity of study outcomes.