GCP QUIZ & Answers 100% correct 2024

what are the three causes that led to the formation of ICH? a. lack of eligible patient to recruit, location of sites, access to treatment b. incomplete medical records, inadequate supplies, equipment not in good working order c. Insufficient laboratory data, sites not conducive to clinical trials, research being conducted is not applicable to the area in which the patient population resides. d. Delays in the introduction of new medicines, differing regulatory requirements from one country to another, rising costs of drug development. correct answersDelays in the introduction of new medicines, differing regulatory requirements from one country to another, rising costs of drug development. What are the International Council for Harmonisation (ICH) Guidelines? a. Written policies for researchers on how to maintain data on un-marketed investigational products. b. Guidelines provided by the Office for Human Research Protection for subjects enrolling in Phase I studies. c. Unified standards to facilitate the mutual acceptance of clinical data by the regulatory authorities in the European Union, Japan and the United States. d. International standards for manufacturing, transporting, and storing medicinal products. correct answersUnified standards to facilitate the mutual acceptance of clinical data by the regulatory authorities in the European Union, Japan and the United States. Which of the following is a principle of ICH GCP? a. Clinical trials should not be conducted if there are any foreseeable risks or inconveniences to trial subjects. b. The medical care given to subjects should always be the responsibility of a qualified monitor assigned by the sponsor. c. Clinical trial information should be recorded, handled, and stored in a way that allows accurate reporting, interpretation, and verification. d. Individuals involved in conducting clinical trials should be qualified by their ability to adhere to ICH GCP. correct answersClinical trial information should be recorded, handled, and stored in a way that allows accurate reporting, interpretation, and verification.