Good Clinical Practice Quizzes- Set 1 Question And Answers 100% Correct 2023/2024

Individuals who participate in a clinical trial, either as recipients of the investigational product(s) or as controls a. trial subjects b. principal investigators c. coordinating investigators d. sub-investigators e. vulnerable subjects {Ans: a. trial subjects}Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, subjects' diaries or evaluation checklists, etc. kept at the pharmacy, at the laboratories and at medical or technical departments involved in the clinical trial). a. Source Documents b. Clinical Study Reports c. Certified Copies d. Clinical Trial Records {Ans: a. Source Documents}A systemic 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 SOPs, GCP, and the applicable regulatory requirements. {Ans: Audit}A document that describes the strategy, methods, responsibilities, and requirements for monitoring the trial. a. Audit Report b. Monitoring Report c. Clinical Development Plan d. Monitoring Plan {Ans: d. Monitoring Plan}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. {Ans: Case Report Form}Any untoward medical occurrence in