Who is responsible for ensuring data protection and access controls for trial data?

• A. The sponsor is responsible for data protection.
• B. The investigator/institution is responsible for ensuring data protection and access controls.
• C. Participants are responsible for data protection.
• D. Regulatory authorities are responsible.

Answer: (B)

Protecting trial data and controlling access is about keeping participant information confidential and ensuring data integrity. The investigator and the institution are responsible for implementing data protection and access controls at the trial site. This means restricting who can view or modify identifiable data to authorized staff, securing electronic systems with appropriate access rights, maintaining audit trails of data changes, and ensuring protections align with consent and privacy laws. The sponsor oversees overall data management and protection for the study, but the day-to-day enforcement of these protections at the site is the investigator/institution’s responsibility. Participants don’t manage data protection, and regulatory authorities establish requirements but don’t handle site-level access controls.