A quality assurance audit of the EDC system SOP revealed a deficiency.

The frequency of data backup is a critical element of an Electronic Data Capture (EDC) system's Standard Operating Procedure (SOP). Ensuring regular and systematic data backup is essential for protecting trial data against loss or corruption. Failure to specify backup frequency indicates a gap in data security management.

GCP guidelines stress that data protection, including regular backups, is essential to maintaining data integrity in clinical trials.

"EDC system SOPs must include clear guidelines on data backup frequency to safeguard the integrity and availability of study data."

Objectives:

Ensure data security through regular backups.

Maintain data integrity in clinical research.