Which statement reflects a data security requirement for electronic data handling?

Which statement reflects a data security requirement for electronic data handling?

• A. Allow open access to all data.
• B. Password sharing among staff is allowed.
• C. Disable data backups.
• D. Maintain a security system that prevents unauthorized access to the data.

Answer: (D)

Data security for electronic data handling focuses on limiting access to those who are authorized and preventing any unauthorized use or disclosure. A robust security system that prevents unauthorized access implements key controls like strong authentication, unique user IDs, access restrictions, encryption where appropriate, audit trails, and regular monitoring. These measures protect participant privacy, maintain data integrity, and ensure data are available when needed, in line with ICH GCP expectations for safeguarding trial information. Open access to all data breaks confidentiality and privacy protections. Sharing passwords among staff undermines authentication and accountability. Disabling data backups risks data loss and undermines data integrity and continuity. Therefore, the statement about maintaining a security system that prevents unauthorized access best reflects the required data security approach.

Data security for electronic data handling focuses on limiting access to those who are authorized and preventing any unauthorized use or disclosure. A robust security system that prevents unauthorized access implements key controls like strong authentication, unique user IDs, access restrictions, encryption where appropriate, audit trails, and regular monitoring. These measures protect participant privacy, maintain data integrity, and ensure data are available when needed, in line with ICH GCP expectations for safeguarding trial information.

Open access to all data breaks confidentiality and privacy protections. Sharing passwords among staff undermines authentication and accountability. Disabling data backups risks data loss and undermines data integrity and continuity. Therefore, the statement about maintaining a security system that prevents unauthorized access best reflects the required data security approach.