Regulatory Affairs Certification (RAC) Practice Exam

How often is an investigator's Curriculum Vitae (CV) required to be updated during an IND study?

1. Monthly

2. Every six months

3. Annually

4. It does not need to be updated

The correct answer is: It does not need to be updated

In the context of an Investigational New Drug (IND) study, an investigator's Curriculum Vitae (CV) is generally required to be updated only when there are relevant changes or at the time of certain specific submissions. The regulation does not stipulate a mandatory frequency for updating the CV throughout the duration of the IND study. Therefore, if no changes occur in an investigator's qualifications or experience that would impact their ability to conduct the study, the CV does not need to be updated regularly. While it is good practice to keep CVs current, regulatory guidance recognizes that repeating the same disclosures at specified intervals, such as monthly or biannually, might not be necessary unless the investigator's status has changed significantly. Thus, the correct perspective aligns with the idea that continuous updates are not required as long as the investigator remains qualified without major changes, allowing flexibility in maintaining accurate documentation as needed.