Which action documents that the investigator or authorized staff confirms the observations recorded in the Case Report Form (CRF)?

Which action documents that the investigator or authorized staff confirms the observations recorded in the Case Report Form (CRF)?

• A. Interim or Annual Reports
• B. Investigational Products Accountability at the Site
• C. Signed, Dated and Completed Case Report Forms (CRF)
• D. Subject Identification Code List

Answer: (C)

Verification of data accuracy is shown when the investigator signs, dates, and completes the Case Report Form, confirming that the recorded observations accurately reflect what was observed and are attributable to the investigator. This action provides traceability to source data and establishes accountability for the information in the CRF. Interim or Annual Reports are communications to sponsors or oversight bodies, not documentation of CRF data verification. Investigational Products Accountability at the Site concerns drug supply and handling, not the CRF observations. The Subject Identification Code List relates to maintaining subject confidentiality and linking data, not confirming the CRF entries. Signing, dating, and completing the CRF best documents the investigator’s confirmation of the recorded observations.

Verification of data accuracy is shown when the investigator signs, dates, and completes the Case Report Form, confirming that the recorded observations accurately reflect what was observed and are attributable to the investigator. This action provides traceability to source data and establishes accountability for the information in the CRF. Interim or Annual Reports are communications to sponsors or oversight bodies, not documentation of CRF data verification. Investigational Products Accountability at the Site concerns drug supply and handling, not the CRF observations. The Subject Identification Code List relates to maintaining subject confidentiality and linking data, not confirming the CRF entries. Signing, dating, and completing the CRF best documents the investigator’s confirmation of the recorded observations.