ACRP CCRC EXAM PREP| 135 Questions| With Complete Solutions 2023 Passed!!

ACRP CCRC EXAM PREP| 135 Questions| With Complete Solutions 2023 Passed!! 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. 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, presentations, and analyses are fully integrated into a single report Comparator (Product) Correct 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) Correct Answer: Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements, and the applicable regulatory requirements. Confidentiality Correct Answer: Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a subject's identity. Contract Correct 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 Correct Answer: A committee that a sponsor may organize to coordinate the conduct of a multicentre trial. Coordinating Investigator Correct Answer: An investigator assigned the responsibility for the coordination of investigators at different centres participating in a multicentre trial. Contract Research Organization (CRO) Correct 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 Correct Answer: Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Documentation Correct 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 Correct Answer: Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced Good Clinical Practice (GCP) Correct 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 trial subjects are protected. Independent Data-Monitoring Committee (IDMC) Correct Answer: An independent datamonitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial. Impartial Witness Correct Answer: A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject's legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject. Independent Ethics Committee (IEC) Correct Answer: An independent body, constituted of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving/providing favourable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. Informed Consent Correct Answer: A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Inspection Correct Answer: The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's and/or contract research organization's (CRO's) facilities, or at other establishments deemed appropriate by the regulatory authority(ies). Institution (medical) Correct Answer: Any public or private entity or agency or medical or dental facility where clinical trials are conducted. Institutional Review Board (IRB) Correct 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 a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.