CCRC 2023 Exam Questions with Correct Answers

CCRC 2023 Exam Questions with Correct Answers Adverse Drug Reaction - ANSWER All noxious and unintended responses to a medicinal product related to any dose should be considered an ADR. Blinding - ANSWER A procedure in which one or more parties to the trial are kept unaware of the treatment assignments. Single Blind - ANSWER Refers to the subject being unaware of the treatment assignment Double Blind - ANSWER Refers to the subject, investigator, monitor, and sometimes analyst being unaware of the treatment. Case Report Form (CRF) - 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. Comparator - ANSWER An investigational or marketed product, or a placebo, used as reference in a clinical trial. Contract Research Organization - ANSWER A person or organization contracted by the sponsor to preform one or more of a sponsor's trial-related duties and functions. Good Clinical Practice (GCP) - ANSWER A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of the trial subjects are protected. Institutional Review Board - ANSWER An independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety, and well-being of human subjects involved in the trial. Investigational Product - ANSWER A pharmaceutical form of an active ingredient or placebo being tested or used as reference in a clinical trial