ACRP CCRC EXAM PREP CORRECTLY SOLVED 2024 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 resp onses 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 do es 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 acc urately 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 aud it 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), monit or, and, in some cases, data analyst(s) being unaware of the treatment assignment(s). 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. Clinical Trial/Study - 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. Clinical Trial/Study Report - Answer ✔️✔️-A writte n description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report Comparator (Product) - Answer ✔️✔️-An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial. Compliance (in relation to trials) - Answer ✔️✔️-Adherence to all the trial -related requirements, Good Clinical Practice (GCP) requirements, and the applicable regulatory requirements. Confidentiality - Answer ✔️✔️-Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a subject's identity. Contract - Answer ✔️✔️-A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. Coordinating Committee - Answer ✔️✔️-A committee that a sponsor may organize to coordinate the conduct of a multicentre trial. Coordinating Investigator - Answer ✔️✔️-An investigator assigned the responsibility for the coordination of investigators at different centres participating in a multicentre trial. Contract Research Organization (CRO) - Answer ✔️✔️-A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial -related duties and functions. Direct Access - Answer ✔️✔️-Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Documentation - Answer ✔️✔️-All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and scans, x -rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken. Essential Documents - Answer ✔️✔️-Documents which individually a nd collectively permit evaluation of the conduct of a study and the quality of the data produced Good Clinical Practice (GCP) - Answer ✔️✔️-A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinica l trials that provides assurance
