ICH GCP for CCRC Exam Prep And Answers

ICH GCP for CCRC Exam Prep 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 respo