Which data are considered source data in a GCP trial and should be recorded directly on the Case Report Form (CRF)?

Which data are considered source data in a GCP trial and should be recorded directly on the Case Report Form (CRF)?

• A. Data recorded directly on the Case Report Form and used as source data
• B. Data stored in a separate file and not part of the CRF
• C. Data printed from the database without source documentation
• D. Data generated solely for internal reports and not verifiable

Answer: (A)

Source data are the original records or documents that contain the information used to evaluate the trial and to reconstruct the study events. When a data value is captured directly on the Case Report Form during a visit or procedure, that CRF entry becomes the original record for that data point and serves as source data for the trial. This provides traceability and verifiability because the CRF entry can be linked back to the patient and to the underlying source documents (such as the patient’s medical chart, lab report, or imaging result) if needed. Data stored separately or printed from the database without accompanying source documentation are not source data because they are not the original record used to generate the trial data, making verification difficult. Data created solely for internal reports and not verifiable also fail to meet the requirement for source data since there is no independent, original record to confirm their accuracy.

Source data are the original records or documents that contain the information used to evaluate the trial and to reconstruct the study events. When a data value is captured directly on the Case Report Form during a visit or procedure, that CRF entry becomes the original record for that data point and serves as source data for the trial. This provides traceability and verifiability because the CRF entry can be linked back to the patient and to the underlying source documents (such as the patient’s medical chart, lab report, or imaging result) if needed.

Data stored separately or printed from the database without accompanying source documentation are not source data because they are not the original record used to generate the trial data, making verification difficult. Data created solely for internal reports and not verifiable also fail to meet the requirement for source data since there is no independent, original record to confirm their accuracy.