- | Page
ACRP CCRC EXAM PREP WITH
COMPLETE SOLUTIONS
Question: What Is An Adverse Drug Reaction (ADR)?
Correct Answer: All Noxious And Unintended
Responses To A Medicinal Product Related To Any Dose
Question: What Is An Adverse Event (AE)?
Correct Answer: Any Untoward Medical Occurrence In
A Patient Or Clinical Investigation Subject Administered A Pharmaceutical Product And Which Does Not Necessarily Have A Causal Relationship With This Treatment--Any Unfavorable And Unintended Sign, Symptom, Or Disease Temporally Associated With The Use Of A Medicinal Product, Whether Or Not Related To The Medicinal Product
Question: What Are Applicable Regulatory
Requirements?
- | Page
Correct Answer: Any Law(S) And Regulation(S)
Addressing The Conduct Of Clinical Trials Of Investigational Products
Question: What Is Institutional Review Board Approval?
Correct Answer: The Affirmative Decision Of The IRB
That The Clinical Trial Has Been Reviewed And May Be Conducted At The Institution Site Within The Constraints Set Forth By The IRB, The Institution, Good Clinical Practice (GCP), And The Applicable Regulatory Requirements
Question: What Is An Audit In The Context Of Clinical
Trials?
Correct Answer: A Systematic And Independent
Examination Of Trial Related Activities And Documents To Determine Whether The Evaluated Trial Related Activities Were Conducted, And The Data Were Recorded, Analyzed And Accurately Reported According To The Protocol, Sponsor's Standard Operating Procedures, (SOPs), Good Clinical Practice (GCP), And The Applicable Regulatory Requirement(S)
- | Page
Question: What Is An Audit Certificate?
Correct Answer: A Declaration Of Confirmation By The
Auditor That An Audit Has Taken Place
Question: What Is An Audit Report?
Correct Answer: A Written Evaluation By The
Sponsor's Auditor Of The Results Of The Audit
Question: What Is An Audit Trail?
Correct Answer: Documentation That Allows
Reconstruction Of The Course Of Events
Question: What Is Blinding/Masking In A Clinical Trial?
Correct Answer: A Procedure In Which One Or More
Parties To The Trial Are Kept Unaware Of The Treatment Assignment(S).
Question: What Is A Case Report Form (CRF)?
- | Page
Correct Answer: A Printed, Optical, Or Electronic
Document Designed To Record All Of The Protocol Required Information To Be Reported To The Sponsor On Each Trial Subject.
Question: What Is A Clinical Trial/Study?
Correct Answer: Any Investigation In Human Subjects
Intended To Discover Or Verify The Clinical, Pharmacological And/Or Other Pharmacodynamic Effects Of An Investigational Product(S), And/Or To Identify Any Adverse Reactions To An Investigational Product(S), And/Or To Study Absorption, Distribution, Metabolism, And Excretion Of An Investigational Product(S) With The Object Of Ascertaining Its Safety And/Or Efficacy
Question: What Is A Clinical Trial/Study Report?
Correct Answer: A Written Description Of A
Trial/Study Of Any Therapeutic, Prophylactic, Or Diagnostic Agent Conducted In Human Subjects, In Which The Clinical And Statistical Description,