According to GCP, how long should clinical trial records be retained?

According to Good Clinical Practice (GCP) guidelines, clinical trial records should be retained for at least two years after the marketing application approval or the conclusion of the trial. This retention period is essential because it ensures that there is sufficient time for the review of safety and efficacy data by regulatory authorities, as well as potential inspections or audits relating to the trial.

The two-year retention period provides a balance between the need for data availability for regulatory scrutiny and the practical considerations of storage and resource management. If a marketing application has not been submitted, the two-year period still begins once the trial concludes, as this is when the data can be finally compiled for review.

This timeframe aligns with the need to maintain comprehensive records for accountability and transparency in clinical research, contributing to the protection of participants and the integrity of data. Therefore, this option is consistent with GCP requirements, emphasizing the importance of preserving trial integrity long enough for thorough evaluation by relevant regulatory authorities and stakeholders involved in the medication development process.