What should be done with trial-related essential documents after the trial when there are still potential marketing applications?

• A. Retain until at least 2 years after last marketing approval or no pending applications
• B. Destroy immediately
• C. Transfer to participants
• D. Archive with no retention requirement

Answer: (A)

Essential documents from a trial must be kept for a defined period to support regulatory scrutiny and ensure the trial’s conduct can be reviewed if questions about safety, data, or compliance arise. The standard guidance is to retain these documents for at least 2 years after the last marketing approval in an ICH region, or until there are no pending marketing applications, whichever is later. This means you don’t discard the trial records while marketing status is being decided, as they may be needed for regulatory actions or inspections. Destroying them immediately, transferring them to participants, or archiving with no retention would all fail to meet this regulatory obligation and could jeopardize future approvals or investigations.