Good Clinical Practice ICH (Questions + Answers) Verified 100% Correct!!.

Adverse drug reaction (ADR) of marketed medicinal products: - Answer-A response to a drug that is noxious and unintended and that occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function 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 sit Audit - Answer-A systematic and independent examination of trial related activities and documents 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. Blinding/Masking - Answer-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 pharmacodynamic effects, record adverse reactions, safety or efficacy of an investigational product(s)..... 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 (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. The protocol may serve as the basis of a contract. 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. 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. 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. Doubleblinding - Answer-Usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s).Essential Documents - Answer-Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced