- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
(1995; 36 pages) [French] [Spanish]
6.5 Case-report forms
The monitor is responsible for ensuring that all case-report forms (CRFs) are correctly filled out in accordance with original observations. Any errors or omissions should be clarified with the investigator, corrected, and explained on the CRF. Procedures should be established for the investigator’s certification of the accuracy of CRFs by a signature, initials or similar method. All procedures for ensuring accuracy of CRFs must be maintained throughout the course of the clinical trial.