What is required when data on the CRF is derived from source documents?

What is required when data on the CRF is derived from source documents?

• A. Discrepancies must be explained but do not need to align with source documents.
• B. Data on the CRF should be consistent with the source documents, or discrepancies should be explained.
• C. The CRF data may be fabricated if source documents are unavailable.
• D. Source documents are optional.

Answer: (B)

Data on the CRF must be consistent with the information in the source documents, or any discrepancies must be explained. Source documents are the original records that provide the evidence for the data collected; the CRF is the study’s record of that data. When there’s a difference between what the source shows and what’s on the CRF, a data clarification process should be used to resolve it—either by correcting the CRF to reflect the source or by documenting a clear, justified explanation supported by the source. This approach ensures data integrity and full traceability for audits. Fabricating data or leaving unresolved discrepancies would undermine participant protection and study validity.

Data on the CRF must be consistent with the information in the source documents, or any discrepancies must be explained. Source documents are the original records that provide the evidence for the data collected; the CRF is the study’s record of that data. When there’s a difference between what the source shows and what’s on the CRF, a data clarification process should be used to resolve it—either by correcting the CRF to reflect the source or by documenting a clear, justified explanation supported by the source. This approach ensures data integrity and full traceability for audits. Fabricating data or leaving unresolved discrepancies would undermine participant protection and study validity.