ICH GCP for CCRC Exam Prep Questions and Correct Answers

ICH GCP for CCRC Exam Prep Questions and Correct Answers 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.