Socra Exam Prep Test Questions With Answers All Correct

Socra Exam Prep Test Questions With Answers All Correct 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 credible