CHAMBERLAIN ACRP CCRC EXAM PREP 2024 QUESTIONS WITH COMPLETE ANSWERS GRADED A+

Adverse Drug Reaction (ADR) - CORRECT ANSWER In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. 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. Applicable Regulatory Requirement(s) - CORRECT ANSWER Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products. Approval (in relation to Institutional Review Boards) - 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. Audit - 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). Audit Certificate - CORRECT ANSWER A declaration of confirmation by the auditor that an audit has taken place. Audit Report - CORRECT ANSWER A written evaluation by the sponsor's auditor of the results of the audit. Audit Trail - CORRECT ANSWER Documentation that allows reconstruction of the course of events. Blinding/Masking - CORRECT ANSWER A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding - CORRECT ANSWER usually refers to the subject(s) being unaware Double- blinding - CORRECT ANSWER usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s). Case Report Form (CRF) - 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. 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.