SOCRA CCRP Practice Exam

Which guidelines define QA and QC in trials?

1. FDA Guidelines

2. ICH GCP Guidelines 1.46 and 1.47

3. EU Clinical Trial Directive

4. WHO Standards

The correct answer is: ICH GCP Guidelines 1.46 and 1.47

The ICH GCP Guidelines 1.46 and 1.47 define QA (Quality Assurance) and QC (Quality Control) in trials. These are international standards that are widely accepted by regulatory agencies and industry professionals. Option A, FDA Guidelines, may cover some aspects of QA and QC, but they are not comprehensive and may differ from other regulatory agency guidelines. Option C, EU Clinical Trial Directive, mainly addresses the conduct of clinical trials in the European Union and does not specifically define QA and QC. Option D, WHO Standards, focuses on the general quality standards for manufacturing and clinical practices, but it does not have specific guidelines for QA and QC in trials. Therefore, Option B is the most accurate choice.