CCRP SOCRA Exam Graded A+

April 30 1996 - ANSWER ICH GCP Development Date Quality - ANSWER ICH Q Efficacy - ANSWER ICH E Safety - ANSWER ICH S Multidisciplinary - ANSWER ICH M guidance for industry, consolidated guideance - ANSWER ICH E 6 Clinical Safety Data Management Definitions and Standards - ANSWER ICH E2A Safety pharmacology studies for human pharmaceuticals - ANSWER ICH S7A Electronic records, electronic signatures - ANSWER 21 CFR Part 11 Informed Consent - ANSWER 21 CFR Part 50 Financial Disclosures - ANSWER 21 CFR Part 54 Institutional Review Board - ANSWER 21 CFR Part 56 IND Application - ANSWER 21 CFR 312 New Drug Application - ANSWER 21 CFR 314 Investigational Device Exemption - ANSWER 21 CFR 812 21 CFR Part 814 - ANSWER pre market approval of medical devices 45 CFR Part 46 - ANSWER Federal Research Studies that investigate the potential undesirable PD effects of a substance on physiological functions in relation to exposure in the therapeutic range or above - ANSWER Safety Pharmacology Studies (Pre-Clinical) 1) To Identify undesirable PD properties of a substance that may have relevance to its human safety. 2) To evaluate adverse PD and/or pathophysio effects of a substance observed in toxicology studies 3)to investigate the mechanism of the adverse PD effects observed and/or suspected - ANSWER Drug Development Safety Pharmacology Study Objectives (3) 1) Cardiovascular 2)Respiratory 3)CNS - ANSWER Three vital organ considered highest priority 1) PK and toxicokinetic 2) Single dose toxicity 3) Repeated dose toxicity 4) Local tolerance 5) Genotoxicity 6) Carcinogenicity 7) Reproduction toxicity 8) Supplemental studies if needed - ANSWER Types of Non-Clinical Studies (Animal Trials) Study that investigates the mode of action and/or effects of a drug substance in relation to its desired therapeutic target - ANSWER Primary Pharmacodynamic Studies Studies that investigate the mode of action and/or effects of a drug substance not related to its desire therapeutic target - ANSWER Secondary Pharmacodynamic Studies Blood Pressure Heart Rate ECG/EKG Repolarization/conductance abnormalities - ANSWER Core Battery for Cardiovascular System Respiratory Rate Functional Assessments (tidal volume, hgb Oxygen saturation) - ANSWER Core Battery for Respiratory System Motor activity behavioral changes coordination sensory/motor reflex response temperature - ANSWER Core Battery for Central Nervous System Investigational New Drug Application FDA - ANSWER Before clinical trials can be initiated, an application containing the appropriate information must be submitted to regulatory authorities, in the USA this is called XXXX and submitted to the XXX (21 CFR Part 312) Unapproved drug to be shipped lawfully for the purpose of conducting investigations of the drug - ANSWER An IND permits what? (21 CFR Part 312) Assuring the safety and rights of subjects - ANSWER FDA's primary objective in all phases of development is... Phase II and III - ANSWER These phase of trials, the FDA helps assure the quality of the scientific evaluation is adequate to permit evaluation of the drugs safety and efficacy (21 CFR Part 312) The FDA - ANSWER Who determines if Phase II/III studies are likely to yield data capable of meeting regulatory standards for marketing approval? 1) Novelty of drug 2)Extent the drug has been studied previously 3) Known of suspected risks 4) Phase of development - ANSWER IND information depends on the amount of information available, these 4 things are: (21 CFR Part 312) General Investigational Plan Protocols for specific human studies - ANSWER Initial IND should focus on (21 CFR Part 312) Build logically on previous submissions Be supported by additional information such as animal studies and other human studies - ANSWER Amendments to IND with new or revised protocols (21 CFR Part 312) Cover Sheet (FDA Form 1571) Table of Contents Introductory statement investigator's brochure protocol (s) Chemistry and manufacturing information pharm and tox information previous human experience with investigational drug - ANSWER A Sponsor Initiated IND must contain (21 CFR Part 312) 30 Days, unless FDA notifies sponsor of clinical hold Upon earlier notification, investigations may begin - ANSWER How long does it take for an IND to go into effect? (21 CFR Part 312) 1)