Good clinical practice Questions And Answers Rated A+

Adverse Drug Reaction (ADR) - all noxious (harmful) and unintended responses to a medicinal product Adverse Drug Reaction (ADR) Regarding marketed medicinal products - normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function Adverse Event (AE) - any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product Audit - 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). Blinding/Masking - A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s) Case Report Form (CRF) - 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 - 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 Comparator (Product) - An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial.Compliance (in relation to trials) - Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements, and the applicable regulatory requirements. Confidentiality - Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a subject's identity. Contract Research Organization (CRO) - 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 - A committee that a sponsor may organize to coordinate the conduct of a multicentre trial. Coordinating Investigator - An investigator assigned the responsibility for the coordination of investigators at different centres participating in a multicentre trial