Socra Exam Prep Questions and Answers (2023) (Verified Answers).

Laws - CORRECT ANS passed by national legislative bodies; establish authority of national regulatory body Regulations - CORRECT ANS Passed by regulatory authorities; controls how medical products are investigated and approved; have effect of law guidance - CORRECT ANS "current thinking" of regulatory bodies; non-binding ICH - CORRECT ANS Developed to keep people doing things the same way across the world; international effort to harmonize the technical requirements for product registration SOPs - CORRECT ANS developed by an organization (sponsor, site, CRO, IRB) Compliance with regulations - CORRECT ANS goal of SOPs organization - CORRECT ANS SOPs are binding only for this European Union, Japan, and the US - CORRECT ANS The ICH makes recommendations for adoption by regulatory authorities in: GCP - CORRECT ANS 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 - CORRECT ANS 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) - CORRECT ANS ICH Q efficacy - CORRECT ANS ICH E safety - CORRECT ANS ICH S Multidisciplinary - CORRECT ANS ICH M QESM - CORRECT ANS 4 series' of the ICH ICH E6 - CORRECT ANS guidance for industry; GCP; consolidated guidance ICH E2A - CORRECT ANS Clinical Safety Data Management: Definitions and Standards for Expedited Reporting CFR and FDA - CORRECT ANS provide guidance for compliance in the US CFR Title 21 - CORRECT ANS focuses on conducting clinical research 21 CFR 11 - CORRECT ANS electronic records and signatures 21 CFR 50 - CORRECT ANS informed consent 21 CFR 54 - CORRECT ANS financial disclosure 21 CFR 56 - CORRECT ANS IRBs 21 CFR 312 - CORRECT ANS Investigational New Drug (IND) application 21 CFR 314 - CORRECT ANS New Drug Application (NDA) 21 CFR 812 - CORRECT ANS Investigational Device Exemption (IDE) 21 CFR 814 - CORRECT ANS Premarket approval for Medical Devices 45 CFR 46 - CORRECT ANS focuses on federal research 21 CFR 50.27 - CORRECT ANS documentation of informed consent Phase I - CORRECT ANS bioavailability, pharmacokinetics, safety Phase II - CORRECT ANS small group of subjects with condition of interest Phase III - CORRECT ANS more experiments, bigger safety profile Drug Development - CORRECT ANS identify potential new compounds; test appropriate laboratory and animal models to assess potential activity in humans; screening may involve thousands of molecules dosage development - CORRECT ANS manufacture pure, stable drug substance (active ingredient); test various formulations to optimize the drug product; stability testing in packaging planned to be used for clinical trials and marketed product Excipients - CORRECT ANS inactive substances used as a carrier for the active ingredients of a medication non/pre-clinical activities - CORRECT ANS drug discovery and development of dosage Safety Pharmacology - CORRECT ANS studies that investigate the potential undesirable pharmacodynamics effects of a substance on physiological functions in relation to exposure in therapeutic range and above Animal studies - CORRECT ANS establish general safety in multiple species; summarize toxicities observed; determine safety margins between the planned human dose range and toxic effects on animals; optimize the dose range, formulation and frequency of administration Single dose toxicity - CORRECT ANS studies in multiple species to select doses for repeated dose studies; look for AEs/SAEs repeated dose toxicity - CORRECT ANS studies to assess toxicity after multiple administrations-results used to determine doses used for chronic administration; look for AEs/SAEs summaries of all acute toxicity studies - CORRECT ANS requirement 1/4 of regulatory application to dose in humans 28-day studies in one rodent and one non-rodent species, usually rats and dogs - CORRECT ANS requirement 2/4 of regulatory application to dose in humans regulatory authorities can require more information - CORRECT ANS requirement