LATEST ICH GCP for CCRC Exam Prep 100% SOLUTION

Adverse Drug Reaction (ADR) - ANSWER All noxious and unintended responses to a medicinal product related to any dose E6(R1) 1 - ANSWER Glossary of terms 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--any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product Applicable Regulatory Requirements - ANSWER Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products Institutional Review Board Approval - 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). 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 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) - ANSWER An investigational or marketed product, or placebo, used as a reference in a clinical trial. Compliance 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 multicenter trial. Coordinating Ivestigator - ANSWER An investigator assigned the responsibility for the coordination of investigators at different centers participating in a multicenter 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 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 and 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 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) (Data and Safety Monitoring Board, Monitoring Committee, Data Monitoring Committee) - ANSWER An independent data- monitoring 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 - 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) - 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 favorable 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 - 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--documented by means of a written, signed and dated informed consent form