What is the requirement for retention and archiving of trial records?

• A. Records kept indefinitely with no restrictions
• B. Records retained for a defined period and kept secure and accessible for inspection
• C. Records destroyed immediately after publication
• D. Retention is not required

Answer: (B)

Retention and archiving of trial records are governed by GCP to ensure the trial’s conduct, results, and safety data can be verified later. Essential documents must be kept for a defined period after the trial is completed (and after any regulatory action or last approval, as required by applicable law) and stored in a way that protects their integrity and confidentiality. They must remain secure and readily accessible to authorized personnel for inspection and audit by regulators or monitors. This defined retention period, plus secure and accessible storage, supports transparency, accountability, and the ability to review the trial if needed. Records being kept indefinitely, destroyed immediately after publication, or not retained at all do not meet these requirements.