SOCRA CCRP Exam Question with complete solution 2023

SOCRA CCRP Exam Question with complete solution 2023April 30 1996 ICH GCP Development Date Quality ICH Q Efficacy ICH E Safety ICH S Multidisciplinary ICH M guidance for industry, consolidated guideance ICH E 6 Clinical Safety Data Management Definitions and Standards ICH E2A Safety pharmacology studies for human pharmaceuticals ICH S7A Electronic records, electronic signatures 21 CFR Part 11 Informed Consent 21 CFR Part 50 Financial Disclosures 21 CFR Part 54 Institutional Review Board 21 CFR Part 56 IND Application 21 CFR 312 New Drug Application 21 CFR 314 Investigational Device Exemption 21 CFR 812 21 CFR Part 814 pre market approval of medical devices 45 CFR Part 46 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 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 Drug Development Safety Pharmacology Study Objectives (3) 1) Cardiovascular 2)Respiratory 3)CNS 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 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 Primary Pharmacodynamic Studies Studies that investigate the mode of action and/or effects of a drug substance not related to its desire therapeutic target Secondary Pharmacodynamic Studies Blood Pressure Heart Rate ECG/EKG Repolarization/conductance abnormalities Core Battery for Cardiovascular System Respiratory Rate Functional Assessments (tidal volume, hgb Oxygen saturation) Core Battery for Respiratory System Motor activity behavioral changes coordination sensory/motor reflex response temperature Core Battery for Central Nervous System Investigational New Drug Application FDA 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 An IND permits what? (21 CFR Part 312) Assuring the safety and rights of subjects FDA's primary objective in all phases of development is... Phase II and III 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 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 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 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 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 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 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 The purpose of Treatment Use of Investigational Drug (21 CFR Part 312)