Certified Clinical Research Coordinator (CCRC) Practice Exam

Generally, who is permitted to make corrections to case report forms?

1. Only the subjects

2. Anyone involved in the trial

3. The CRC or the investigator

4. IRB personnel only

The correct answer is: The CRC or the investigator

The role of making corrections to case report forms (CRFs) is critical to maintaining the integrity of the data collected during a clinical trial. The correct option, which identifies that the CRC (Certified Clinical Research Coordinator) or the investigator is typically permitted to make these corrections, reflects the established protocols in clinical research. The CRC and the investigator are responsible for the accuracy and completeness of the data collected. They have the necessary training and authority to make any amendments required to maintain data integrity, ensure compliance with regulatory standards, and uphold the scientific validity of the trial results. Any changes must be documented appropriately, often with a reason for the correction and the date, to ensure a transparent audit trail. In contrast, allowing anyone involved in the trial or IRB personnel to make changes could compromise data integrity and accountability, as they may not have the same depth of understanding regarding the trial protocol or the proper methods of documentation. Subjects being allowed to make corrections is also not appropriate because they are typically not trained to interpret study protocols or understand the implications of data entry. It is paramount that only qualified personnel, namely the CRC or the investigator, handles data corrections on CRFs to ensure the clinical trial data remains reliable and valid throughout the study.