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ACRP CCRA Exam 2026 Questions and Answers

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ACRP CCRA Exam 2026 Questions and Answers

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ACRP CCRA Exam 2026 Questions and
Answers

Declaration of Helsinki (1964) - Correct answer-the World Medical Association

established recommendations guiding medical doctors in biomedical research

involving human participants.

ICH E2A - Correct answer-Clinical Safety Data Management - a document which

describes the sponsor's responsibilities pertaining to safety and reporting AEs

(Adverse Events)

ICH E6 - Correct answer-Guideline for good clinical practice - falls under the

"efficacy" category. It pertains specifically to the conduct of clinical research to

support marketing applications for drugs

ICH E8 - Correct answer-Guidance on General Considerations for Clinical Trials -

describes drug development process and ICH guidelines of safety and efficacy of

investigational products

ICH E9 - Correct answer-Guidelines for Statistical Principles for Clinical Trials

ICH E11 - Correct answer-Guidelines for Clinical Trials in Pediatric Population

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