Socra Exam Prep Questions With Solved Solutions

Laws - ANSWER-passed by national legislative bodies; establish authority of national regulatory body Regulations - ANSWER-Passed by regulatory authorities; controls how medical products are investigated and approved; have effect of law guidance - ANSWER-"current thinking" of regulatory bodies; non-binding ICH - ANSWER-Developed to keep people doing things the same way across the world; international effort to harmonize the technical requirements for product registration SOPs - ANSWER-developed by an organization (sponsor, site, CRO, IRB) Compliance with regulations - ANSWER-goal of SOPs organization - ANSWER-SOPs are binding only for this European Union, Japan, and the US - ANSWER-The ICH makes recommendations for adoption by regulatory authorities in: GCP - ANSWER-guidelines developed by the ICH for global implementation on April 30, 1996; developed in consideration of the current practices of the EU, Japan, US as well as Australia, Canada, the Nordic countries, and the WHO GCP Compliance - ANSWER-an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve human subjects; provides public assurance that the rights, safety and well-being of trial subjects are protected and that the clinical trial data are credibl