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
©COPYRIGHT 2025, ALL RIGHTS RESERVED 1
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
©COPYRIGHT 2025, ALL RIGHTS RESERVED 1