Which statement best describes data quality requirements for CRFs and required reports?

Which statement best describes data quality requirements for CRFs and required reports?

• A. Data should be accurate and complete, but legibility is not required.
• B. Data must be reported only at the end of the trial.
• C. Data must be accurate, complete, legible, and timely for CRFs and required reports.
• D. Data may be missing if time is limited.

Answer: (C)

In ICH-GCP practice, data captured on case report forms (CRFs) and in required reports must be accurate, complete, legible, and timely. Accuracy ensures the records reflect what actually happened in the study; completeness means there are no missing data that could bias results or undermine analyses; legibility guarantees that anyone reviewing the data can read and interpret it reliably; timeliness ensures data is entered and reported promptly, supporting ongoing monitoring, safety assessment, and regulatory review. Together, these qualities uphold data integrity and traceability from source documents to the study records. The other ideas fall short because legibility cannot be ignored, data quality requires ongoing reporting rather than only at the end, and missing data is not acceptable without predefined handling—none of which align with the standard expectations for CRFs and required reports.

In ICH-GCP practice, data captured on case report forms (CRFs) and in required reports must be accurate, complete, legible, and timely. Accuracy ensures the records reflect what actually happened in the study; completeness means there are no missing data that could bias results or undermine analyses; legibility guarantees that anyone reviewing the data can read and interpret it reliably; timeliness ensures data is entered and reported promptly, supporting ongoing monitoring, safety assessment, and regulatory review. Together, these qualities uphold data integrity and traceability from source documents to the study records.

The other ideas fall short because legibility cannot be ignored, data quality requires ongoing reporting rather than only at the end, and missing data is not acceptable without predefined handling—none of which align with the standard expectations for CRFs and required reports.