Which features are essential for an Electronic Data Capture (EDC) system's security?

Which features are essential for an Electronic Data Capture (EDC) system's security?

• A. Access controls, audit trails, data validation, encryption, backups, and validated workflows.
• B. Shared passwords between users.
• C. No backups and no encryption.
• D. Unrestricted access for all users.

Answer: (A)

Protecting data in an EDC system means carefully controlling who can access it, recording every action, ensuring data quality, protecting data in storage and transit, keeping reliable backups, and enforcing standardized workflows. Access controls limit privileges to authorized users, so only the right people can view or modify data. Audit trails provide a traceable history of who did what and when, which is essential for accountability and regulatory compliance. Data validation helps catch and prevent errors at entry, preserving data accuracy. Encryption protects sensitive information from unauthorized disclosure. Backups ensure data can be restored after loss or corruption, maintaining availability. Validated workflows enforce consistent procedures, reducing the risk of deviations that could compromise data integrity or trial results. Together these features safeguard confidentiality, integrity, availability, and traceability—key requirements for secure EDC operations. Sharing passwords weakens access controls and obliterates auditability; no backups and no encryption expose data to loss and breaches; unrestricted access gives everyone the ability to view and change data, undermining security and confidentiality.

Protecting data in an EDC system means carefully controlling who can access it, recording every action, ensuring data quality, protecting data in storage and transit, keeping reliable backups, and enforcing standardized workflows. Access controls limit privileges to authorized users, so only the right people can view or modify data. Audit trails provide a traceable history of who did what and when, which is essential for accountability and regulatory compliance. Data validation helps catch and prevent errors at entry, preserving data accuracy. Encryption protects sensitive information from unauthorized disclosure. Backups ensure data can be restored after loss or corruption, maintaining availability. Validated workflows enforce consistent procedures, reducing the risk of deviations that could compromise data integrity or trial results. Together these features safeguard confidentiality, integrity, availability, and traceability—key requirements for secure EDC operations. Sharing passwords weakens access controls and obliterates auditability; no backups and no encryption expose data to loss and breaches; unrestricted access gives everyone the ability to view and change data, undermining security and confidentiality.