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) To facilitate the availability of promising new drugs available to desperately ill patients as early in the drug development process as possible, before general marketing begins 2)To obtain additional data on the drug's safety and effectiveness - ANSWER The purpose of Treatment Use of Investigational Drug (21 CFR Part 312) 1) The drug is intended to treat a serious or immediately life threatening disease 2) No comparable or satisfactory alternative drug/therapy is available to treat the stage of disease in the intended patient population - ANSWER A treatment protocol or IND may be filed if: ((21 CFR Part 312) Phase II/ III trials or After all the clinical trials have been completed and the sponsor of the controlled clinical trial is actively pursuing marketing approval of the drug with due dilligence - ANSWER A treatment protocol or IND are usually found in what phase of trials? 30-Day Waiting Period - ANSWER How long is the waiting period before the study can initiate after the treatment IND is submitted? Need for investigational drug arises in an emergency situation Insufficient time to allow for submission of an IND or a treatment IND Request for specified use by telephone or other rapid means of communication - ANSWER Emergency use of an investigational product (21 CFR Part 312) 5 Working Days - ANSWER How quickly must a site notify the IRB of an emergency use of investigational drug? (21 CFR Part 312) 1) Notifying the FDA 2) Stopping all studies and notifying the investigators 3)All drug returned to the sponsor or destroyed as directed by sponsor 4)If withdrawn due to safety reasons, the sponsor must notify the investigators and the IRBs of those reasons - ANSWER Sponsors have the right with withdraw an IND at anytime, without prejudice by completing the following: (21 CFR Part 312) An order issued by the FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation - ANSWER What is a "Clinical Hold" Subjects may not be given the investigational drug - ANSWER What does a FDA "Clinical Hold" mean for a proposed study? no new subjects may be given the IP and subjects already taking the drug should be discontinued unless continuation is specifically permitted by the FDA - ANSWER What does a FDA "Clinical Hold" mean for an ongoing study? 1) Subjects exposed to unreasonable risk, illness or injury 2)Clinical investigators are not qualified 3)Investigator's brochure is misleading, inaccurate or materially incomplete 4)The IND does not contain sufficient information to assess risk to subjects - ANSWER Grounds for FDA Clinical Hold in Phase 1 Trials 1) All grounds related to holds in Phase 1 trials AND 2) The protocol is clearly deficient in design to meet the stated objects - ANSWER Grounds for FDA Clinical Hold in Phase II/III Trials 1) Initial Safety, dose escalation studies to determine MTD 2) PK and PD property, might be cross over design 3) Absorption, distribution, metabolism and excretion studies 4) Efficacy assessment, if possible - ANSWER Types of Phase I Trials 1) Initial demonstration of efficacy in subjects with the condition under investigation 2) obtain short term safety - ANSWER Goals of Phase II Trials 1) Confirmation of short term efficacy and safety 2) Establish long term efficacy and safety 3) Assess overall therapeutic value - ANSWER Goals of Phase III trials Phase III - ANSWER What phase of study usually has the largest number of subjects per study? Phase I - ANSWER What phase of study is usually single-center? Phase II/III - ANSWER What phases of stuides are usually multicenter? 1) Address FDA requirements for additional information not in NDA 2) Continue to assess overall therapeutic value 3)Surveillance for less common adverse events - ANSWER Goals of Phase IV Trials 1976 - ANSWER What year was the Medical Device Amendment? Medical Device Reporting - ANSWER 21 CFR Part 803 Investigational Device Exemption - ANSWER 21 CFR Part 812 Premarket Approval of Medical Devices - ANSWER 21 CFR Part 814 Quality System Regulations - ANSWER 21 CFR Part 820 Medical Device Classification Procedures - ANSWER 21 CFR Part 860 1) Achieve their primary intended purpose through chemical action within the body 2) Are dependent upon being metabolized for the primary achievement of the primary intended purpose - ANSWER Device definitions excludes what 2 type of products 1976, With Medical Device Amendments - ANSWER When was 510K Clearance Established? Clearance - ANSWER What is a 510k?