Which statement best describes the handling of changes or corrections to the CRF?

• A. Changes may be made without dating or initials.
• B. Changes must be dated and initialed, and should not obscure the original entry.
• C. Changes may be made by the sponsor without investigator endorsement.
• D. No explanation is required for changes.

Answer: (B)

Any modification to the CRF must be traceable and preserve the original data. That means the change or correction has to be dated and initialed by the person making it, and the original entry must remain legible and not be obscured. This creates an audit trail that shows what was entered, who corrected it, and when, which is essential for data integrity and regulatory compliance in clinical trials. The standard practice is to not erase or hide the original entry; instead, you mark the error (often with a single line through it) and record the corrected information with the date and initials, keeping the original visible. Corrections are typically made by the investigator or authorized study personnel who entered the data, and not unilaterally by the sponsor without investigator endorsement. If a change is made, a brief justification is usually documented so reviewers understand why the correction was necessary.