What records must investigators and institutions retain?

• A. Essential records for the required retention period.
• B. Clinical trial protocol documents.
• C. Adverse event reports only.
• D. Financial accounting records.

Answer: (A)

Essential records must be kept for the required retention period. In Good Clinical Practice, investigators and institutions retain the set of essential documents that allow evaluation of the trial’s conduct and the quality of the data. This goes beyond any single document type and includes items such as the protocol and amendments, IRB/IEC approvals, informed consent forms, case report forms and data, participant recruitment logs, sponsor correspondence, monitoring and audit reports, and relevant lab results or final study reports. These records stay in place for the retention period mandated by the protocol and regulatory authorities, or longer if required to support safety and data integrity. Financial records may be kept for audits, but they do not replace the need to retain essential trial documents for the regulatory review of the study.