Good Clinical Practice ICH question n answers graded A+

Good Clinical Practice ICH What is Good Clinical Practice (GCP)? - correct answer An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects What does Good Clinical Practice assure? - correct answer Assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. What is the objective Good Clinical Practice Guideline? - correct answer To provide a unified standard for the European Union (EU), Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. Good Clinical Practice Guideline was developed by? - correct answer European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries, and the World Health Organization (WHO). When should Good Clinical Practice Guideline be followed? - correct answer When generating clinical trial data that are intended to be submitted to regulatory authorities. May also be applied to other clinical investigations that may have an impact on the safety and well-being of human subjects. What is Adverse drug reaction (ADR)? - correct answer All noxious and unintended responses to a medicinal product related to any dose. A causal relationship between a medicinal product and an adverse event. Adverse drug reaction (ADR) of marketed medicinal products: - correct 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): - 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 sit Audit - correct answer A systematic and independent examination of trial related activities and documents 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. Blinding/Masking - correct answer 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 Doubleblinding - 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 pharmacodynamic effects, record adverse reactions, safety or efficacy of an investigational product(s)..... 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.