SOCRA CCRP Exam 2023
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)
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