Which statement about source data verification is correct?

Which statement about source data verification is correct?

• A. Only data from central databases must be audited
• B. Data stored in CRFs do not require source documents
• C. All data recorded on the CRFs should be traceable to source documents
• D. Source documents are optional for data verification

Answer: (C)

Source data verification ensures that every data point entered on the case report form has a real, original source document that can be traced back to it. This traceability is essential for data integrity in GCP because it confirms that the information recorded actually reflects what occurred with the participant, such as lab results, clinical notes, and other source records. Therefore, all data on the CRFs should be linked to corresponding source documents so you can verify accuracy, completeness, and authenticity. The other statements don’t fit because audits aren’t limited to central databases; data on CRFs must be verifiable against source documents, and source documents are not optional for data verification.

Source data verification ensures that every data point entered on the case report form has a real, original source document that can be traced back to it. This traceability is essential for data integrity in GCP because it confirms that the information recorded actually reflects what occurred with the participant, such as lab results, clinical notes, and other source records. Therefore, all data on the CRFs should be linked to corresponding source documents so you can verify accuracy, completeness, and authenticity.

The other statements don’t fit because audits aren’t limited to central databases; data on CRFs must be verifiable against source documents, and source documents are not optional for data verification.