What must be maintained regarding records in clinical trials?

• A. Record integrity and traceability must be maintained, and personal information should be protected.
• B. Records can be altered freely.
• C. Traceability is optional.
• D. Privacy can be ignored if data is anonymized.

Answer: (A)

In clinical trials, records must be kept with both data integrity and protection of participant privacy in mind. This means keeping data that are attributable, legible, contemporaneous, original, and accurate, with any changes clearly auditable so you can trace what happened and when. At the same time, personal information of participants must be protected and handled confidentially, using appropriate safeguards even when data are de-identified. Freely altering records would break integrity, making traceability optional would erase accountability, and ignoring privacy—even if data are anonymized—violates protections for participants and GCP expectations.