Socra Exam Prep questions and answers

Laws - passed by national legislative bodies; establish authority of national regulatory body Regulations - Passed by regulatory authorities; controls how medical products are investigated and approved; have effect of law guidance - "current thinking" of regulatory bodies; non-binding ICH - Developed to keep people doing things the same way across the world; international effort to harmonize the technical requirements for product registration SOPs - developed by an organization (sponsor, site, CRO, IRB) Compliance with regulations - goal of SOPs organization - SOPs are binding only for this European Union, Japan, and the US - The ICH makes recommendations for adoption by regulatory authorities in: GCP - 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 - 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 quality (chemistry manufacturing and control data; CMC) - ICH Q efficacy - ICH E safety - ICH S Multidisciplinary - ICH M QESM - 4 series' of the ICH ICH E6 - guidance for industry; GCP; consolidated guidance ICH E2A - Clinical Safety Data Management: Definitions and Standards for Expedited Reporting CFR and FDA - provide guidance for compliance in the US CFR Title 21 - focuses on conducting clinical research 21 CFR 11 - electronic records and signatures 21 CFR 50 - informed consent 21 CFR 54 - financial disclosure 21 CFR 56 - IRBs 21 CFR 312 - Investigational New Drug (IND) application 21 CFR 314 - New Drug Application (NDA) 21 CFR 812 - Investigational Device Exemption (IDE) 21 CFR 814 - Premarket approval for Medical Devices 45 CFR 46 - focuses on federal research 21 CFR 50.27 - documentation of informed consent Phase I - bioavailability, pharmacokinetics, safety Phase II - small group of subjects with condition of interest Phase III - more experiments, bigger safety profile