ACRP CCRC EXAM PREP, CCRC Exam Prep, ACRP CCRC, CCRC Study Guide

Adverse Drug Reaction (ADR) - 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) - 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) - Answer- Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products. Approval (in relation to Institutional Review Boards) - 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 - 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 - Answer- A declaration of confirmation by the auditor that an audit has taken place. Audit Report - Answer- A written evaluation by the sponsor's auditor of the results of the audit. Audit Trail - Answer- Documentation that allows reconstruction of the course of events. Blinding/Masking - Answer- A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding - Answer- usually refers to the subject(s) being unaware Double- blinding - Answer- usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s).