SOCRA certification: Class Quizzes Week 1-5 With Complete Solutions

The ICH is concerned with harmonization of technical requirements for registration of pharmaceutical products from what three regions? - ANSWER-European Union, Japan and United States What organizations are represented in the ICH Steering Committee? - ANSWER-Australia, Canada, the Nordic countries and the World Health Organization (WHO), European Union, Japan, and the United States What ethical standards are the ICH Documents based on? - ANSWER-Declaration of Helsinki What is the status of ICH in U.S.? - ANSWER-It is a guideline A primary purpose of the ICH is to: A. Develop mandatory worldwide regulations for drug development B. Require publication of negative trial results. C. Minimize the need for redundant research. D. Require FDA registration of worldwide clinical trials. - ANSWER-C. Minimize the need for redundant research The ICH GCP Guidelines: A. Replace FDA regulations for internationally conducted studies of drugs that will be marketed in the U.S. B. Require certification of clinical research sites and investigators. C. Guarantee that a submission in any ICH region will be approved for marketing. D. Set standards for the design, conduct, monitoring and reporting of clinical research. - ANSWER-D. Set standards for the design, conduct, monitoring and reporting of clinical research.