Which document includes original records related to the trial, to medical treatment, and history of the subject and substantiates the trial data?

Which document includes original records related to the trial, to medical treatment, and history of the subject and substantiates the trial data?

• A. Informed Consent Forms
• B. Monitoring Visit Reports
• C. CVs
• D. Source Documents

Answer: (D)

Source documents are the original records that capture the participant’s medical history, the treatments given, and the data collected during the trial. They serve as the evidence that supports what’s recorded on the case report form, since the CRF entries are derived from these primary sources. The data must be traceable back to the source documents, and any corrections on the source records should be dated and signed to maintain an auditable trail. Examples include hospital charts, lab reports, clinician notes, prescriptions, and imaging results. In contrast, informed consent forms document consent to participate, monitoring visit reports describe oversight activities, and CVs show staff qualifications. Because source documents contain the actual, original data for the study, they are the ones that substantiate the trial data.

Source documents are the original records that capture the participant’s medical history, the treatments given, and the data collected during the trial. They serve as the evidence that supports what’s recorded on the case report form, since the CRF entries are derived from these primary sources. The data must be traceable back to the source documents, and any corrections on the source records should be dated and signed to maintain an auditable trail. Examples include hospital charts, lab reports, clinician notes, prescriptions, and imaging results. In contrast, informed consent forms document consent to participate, monitoring visit reports describe oversight activities, and CVs show staff qualifications. Because source documents contain the actual, original data for the study, they are the ones that substantiate the trial data.