Which statement is a required characteristic of changes or corrections to CRFs?

Which statement is a required characteristic of changes or corrections to CRFs?

• A. They must be dated and initials
• B. They may obscure the original entry
• C. They need no explanation
• D. They can be made only on paper records

Answer: (A)

Corrections to CRFs must be traceable to maintain data integrity. The essential requirement is that any change includes who made the correction and when it was made—dated and initials. This creates an auditable record showing that a data point was reviewed and corrected by an authorized person, preserving accountability for every entry. It also helps ensure the original entry remains readable and the change is transparently documented. In practice, this means you shouldn’t obscure the original data, and you should accurately note the corrected value with the date and your initials.

Corrections to CRFs must be traceable to maintain data integrity. The essential requirement is that any change includes who made the correction and when it was made—dated and initials. This creates an auditable record showing that a data point was reviewed and corrected by an authorized person, preserving accountability for every entry. It also helps ensure the original entry remains readable and the change is transparently documented. In practice, this means you shouldn’t obscure the original data, and you should accurately note the corrected value with the date and your initials.