What is the investigator's responsibility regarding trial data integrity?

• A. To ensure the integrity of data under their responsibility, regardless of the media used.
• B. To ensure data integrity only for paper records
• C. The sponsor is responsible for all data integrity
• D. Data integrity applies only to safety data

Answer: (A)

In GCP, investigators are responsible for the integrity of all trial data under their control, regardless of the media used. Data must be accurate, complete, and verifiable, and must be handled and stored in a way that supports reliable trial results. This obligation covers both paper and electronic records, and extends to all data collected or generated by the investigator, not just safety information. The sponsor has overarching responsibilities for data management, but the investigator cannot delegate responsibility for data they oversee or generate.