CITI Training Practice Exam

What regulation must a principal investigator comply with to use an electronic data capture system for a clinical trial?

1. HIPAA

2. 21 CFR Part 11

3. FDA Guidelines

4. ICH GCP

The correct answer is: 21 CFR Part 11

A HIPAA is the Health Insurance Portability and Accountability Act, which ensures the privacy and security of patient health information. While it is important for a principal investigator to comply with HIPAA in any clinical trial, it does not specifically address the use of electronic data capture systems. C: FDA Guidelines cover various aspects of clinical trials, including proper conduct, documentation, and approval processes, but they do not specifically address the use of electronic data capture systems. D: ICH GCP (International Council for Harmonisation Good Clinical Practice) is a set of ethical and scientific quality standards for designing, conducting, and reporting clinical trials. While it is important for a principal investigator to comply with ICH GCP in any clinical trial, it does not specifically address the use of electronic data capture systems. Therefore, the correct answer is B: 21 CFR Part 11, which specifically