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SQA Registered Quality Assurance Professional (RQAP) Practice Exam

SQA — The Society of Quality Assurance (SQA) awards the Registered Quality Assurance Professional (RQAP) credential in GLP and GCP disciplines; the computer-based exam covers FDA regulations, OECD Principles, and ICH guidelines with approximately 100 questions and a 75% passing threshold.

29
Questions
120m
Time Limit
75.00%
To Pass
Question 1 of 29👑 VIP

A Quality Assurance auditor at a contract research organization is reviewing a toxicology study. During a phase inspection, she discovers that the Study Director signed the protocol amendment three days after dosing under the amended conditions had already begun. The Study Director argues that the science was sound and no animals were harmed. Under FDA GLP regulations (21 CFR Part 58), what is the correct assessment of this situation?

Questions 2–29 and full explanations are VIP-exclusive.