According to ICH GCP EC 1.11, a case report form is a printed, optical, or electronic document designed to record all of the protocol required information to be reported on each trial subject. CRFs are designed by the sponsor or sponsor-investigator and maintained at the investigative site. Information documented on the CRF (or eCRF) must be supported by source documentation. At a minimum the CRF should record:
- Inclusion/exclusion criteria and assessment as to whether the subject met them
- Protocol-specific clinical laboratory testing (including EKGs, X-rays, eye exams, scans, etc.) documented by laboratory records
- All AEs, SAEs, concomitant therapies, and/or inter-current illnesses
- Assessment of severity of AEs, relationship to test article, and expectedness of the AE
- Report of all dropouts and the reasons
One of the most essential tasks performed by the Clinical Research Coordinator (CRC) is completing and/or ensuring the completion of the subject’s CRF. Most sponsors will provide instructions or a guide for CRF completion. Handwriting must be legible and should be completed in black ink. All data points must be addressed and for fields that cannot be completed, “not available,” “not done” or “unknown” should be marked in accordance with the sponsor’s instructions. The CRC will ensure that all required data are collected and entered on the CRF as soon as possible after, if not during, the visit. All CRFs should be checked for completeness and legibility. The CRFs should be reviewed and signed by the investigator prior to submission. Only those physicians identified on the 1572 may sign CRFs. When making a correction on a CRF, a single line should be drawn through the incorrect entry and the correct data should be entered above or next to the incorrect entry. The correction should be dated and initialed. White-out or eraser should never be used to correct an error. Blanks identified prior to the investigator’s review and sign-off on the CRF can simply be completed. Those identified after sign-off must be dated and initialed.