CRF Review and Source Data Verification

CRF (Case Report Form) review and source data verification are important components of clinical trial quality management. CRF review is the process of reviewing the study data recorded on the CRFs to ensure that it is complete, accurate, and consistent with the source documentation, such as the subject medical records and laboratory data. Source data verification is the process of verifying the accuracy of the study data recorded on the CRFs by comparing it to the original source documentation.

The objective of this is to ensure the quality and integrity of the study data, to prevent data errors and inaccuracies, and to detect and resolve any discrepancies between the study data recorded on the CRFs and the source documentation.

The following are some of the steps involved:

1. Preparation: The CRF reviewer and source data verifier should be trained on the study protocol, the CRF design, and the applicable GCP and regulatory requirements. They should also review the study data entry guidelines and the data query resolution process.
2. CRF Review: The CRF reviewer reviews the study data recorded on the CRFs to ensure that it is complete, accurate, and consistent with the source documentation. The reviewer may also perform data checks, such as range checks and consistency checks, to detect data outliers and inconsistencies.
3. Source Data Verification: The source data verifier verifies the accuracy of the study data recorded on the CRFs by comparing it to the original source documentation, such as the subject medical records and laboratory data.
4. Discrepancy resolution: If any discrepancies are identified during the CRF review or source data verification process, the verifier raises a data query to the site to resolve the discrepancy. The site should provide a written response to the query, and the discrepancy should be documented and resolved in a timely manner.
5. Documentation: The CRF reviewer and source data verifier should document the results of the CRF review and source data verification, including any discrepancies identified and the resolution process, in a monitoring report.

CRF review and source data verification are ongoing processes that occur throughout the study, and they are critical to ensure the quality and integrity of the study data and to protect the rights, safety, and welfare of the study subjects. The frequency and intensity of CRF review and source data verification can vary depending on the complexity and risk profile of the study, but they are generally performed on a regular basis, such as every 3-6 months.

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