CR014 exam 2024 with 100% correct answers

declaration of helsinki (1964) correct answers-ethical principles (31) for research with human subjects -international standard -subjects take precedence -combing research and clinical care -adapted from Nuremberg Code by the World Medical Association ICH - international conference on harmonisation correct answersinternational authority on clinical research theory and principles ICH guidelines correct answers4 major categories QUALITY - chemical/pharm. Assurance (stability testing, impurity testing etc) SAFETY - in vitro/vivo pre-clinical studies (carcinogen/genotoxicity testing) EFFICACY - clinical studies in humans (dose response, GCP) MULTIDISCIPLINARY - crossing topics that dont fit in one (MedDRA, ESTRI etc) ESTRI correct answersElectronic Standards for Transmission of Regulatory Information GCP correct answersICH E6: good clinical practice standard for design, conduct, performance, monitoring, auditing, recording, analyses, reporting of clinical trials.