What must be documented according to Good Clinical Practice (GCP)?

According to Good Clinical Practice (GCP), it is essential to document detailed records of all trial-related activities, including data management. This encompasses a wide range of activities, such as the study protocol, informed consent forms, case report forms, monitoring reports, and any correspondence related to the trial. Comprehensive documentation ensures that the research can be replicated, that the integrity of the data is maintained, and that regulatory requirements are met.

Thorough records are crucial for the validity of the clinical trial, as they provide evidence that the study was conducted according to the established protocols and that ethical standards, including participant safety and data protection, were upheld. This level of documentation also supports the transparency and accountability of the research process, allowing for thorough auditing and review if necessary.

While other aspects, like discussions among researchers, might be important for internal communication, they do not need to be documented in the same manner as trial-related activities. Regular updates on recruitment strategies are indeed important but are only part of the comprehensive documentation required for a clinical trial. Focusing solely on the final results and conclusions would not provide the necessary insights into how those results were achieved, nor would it reflect adherence to GCP standards throughout the study.