What is a Case Report Form (CRF)?

Data can be collected either on paper or electronically via an eCRF (electronic Case Report Form). Electronic systems provide structured data entry forms, plausibility checks, and audit trails.

Requirements for (e)CRFs:

• Legibility: All entries must be clearly legible and complete, and must be made in permanent ink.
• Corrections: Incorrect entries must be corrected in such a way that the original value remains legible (single strikethrough, date, initials of the person making the corrections).
• Completeness: All intended fields must be completed; missing values must be explained (e.g., “not collected”, “not applicable”).
• Storage: (e)CRFs must be protected against loss, damage, and unauthorised access and retained in accordance with applicable regulatory retention periods.
• Validation: (e)CRF systems must be reviewed in accordance with a validation plan prior to use (e.g., functional and security testing, with documentation of validation results).
• Data integrity: Systems must be operated to ensure data is protected against unauthorised access, loss, alteration, or destruction (access controls, backups, encryption).
• Traceability: All changes must be version-controlled and fully traceable via an audit trail, including time, user, and reason.
• Data protection: Anonymisation or pseudonymisation of data and role-based access control are mandatory.
• Compliance: Processes align with ISO 20916 (clinical performance studies with human specimens).