ACRP-CP Exam Review (Based on Declaration of Helsinki and ICH E2A, E6_R2, E8, E9, E11)2023 – 2024 Already Passed With complete solution

Adverse Drug Reaction (ADR) - CORRECT ANSWER All noxious and unintended responses to a medicinal product related to any dose (causal relationship is at least a reasonable possibility). Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function Adverse Event (AE) - CORRECT ANSWER Any untoward medi-cal occurrence in a patient or clinical investigation subject adminis-tered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. (ICH GCP E6 1.2) Audit - CORRECT ANSWER A systematic and independent exam-ination 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 Prac-tice (GCP), and the applicable regulatory requirement(s). Audit Trail - CORRECT ANSWER Documentation that allows re-construction of the course of events. Blinding/Masking - CORRECT ANSWER A procedure in which one or more parties to the trial are kept unaware of the treatment as-signment. Single-blinding usually refers to the subject(s) being una-ware, and double- blinding usually refers to the subject(s), investiga-tor(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s). (ICH GCP E6 1.10)