Good Clinical Practice Ich Study Guide Graded A+

Clinical Trial/Study {Ans: 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).....}Case Report Form (CRF) {Ans: 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.}Approval (in relation to Institutional Review Boards) {Ans: The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution sit}Monitoring Report {Ans: A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsorís SOPs}Sponsor {Ans: An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial}Informed Consent {Ans: A subject voluntarily confirms his or her willingness to participate in a trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form. Copy to subject must be SIGNED and DATED (FDA not signed copy)}Documentation {Ans: All