Certified Clinical Research Coordinator (CCRC) Practice Exam

An investigator conducting a study of a medical device under an IDE is required to complete which document?

1. A case report form

2. An investigator's agreement

3. A patient information sheet

4. A regulatory submission form

The correct answer is: An investigator's agreement

The investigator's agreement is a crucial document required when conducting a study of a medical device under an Investigational Device Exemption (IDE). This agreement outlines the responsibilities and obligations of the investigator in relation to the study, ensuring compliance with federal regulations and the protocol of the study. It serves as a binding contract between the institution and the investigator, confirming that the investigator will conduct the study according to the protocol, will maintain accurate records, and will adhere to regulatory requirements. While the other documents mentioned serve important roles in clinical research, they do not fulfill the specific requirement associated with an IDE. A case report form is used to collect data from study participants, a patient information sheet provides necessary details to participants about the study, and a regulatory submission form relates to the broader regulatory processes but not specifically to the investigator's commitments. Thus, the investigator's agreement is the correct and necessary document for this context.