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SOCRA CCRP EXAM ACTUAL EXAM 200 QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES |AGRADE
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SOCRA CCRP EXAM ACTUAL EXAM 200 QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES |AGRADE
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SOCRA CCRP EXAM 2024-2025 ACTUAL EXAM200 QUESTIONS AND CORRECT DETAILED
ANSWERS WITH RATIONALES |AGRADE
Terms in this set (199)
ICH GCP Development April 30 1996
Date
ICH Q Quality
ICH E Efficacy
ICH S Safety
ICH M Multidisciplinary
ICH E 6 guidance for industry, consolidated guideance
Clinical Safety Data Management Definitions and
ICH E2A
Standards
Safety pharmacology studies for human
ICH S7A
pharmaceuticals
21 CFR Part 11 Electronic records, electronic signatures
21 CFR Part 50 Informed Consent
21 CFR Part 54 Financial Disclosures
21 CFR Part 56 Institutional Review Board
21 CFR 312 IND Application
21 CFR 314 New Drug Application
21 CFR 812 Investigational Device Exemption
pre market approval of 21 CFR Part 814
medical devices
, Federal Research 45 CFR Part 46
Studies that investigate the potential undesirable PD
Safety Pharmacology
effects of a substance on physiological functions in
Studies (Pre-Clinical)
relation to exposure in the therapeutic range or above
1) To Identify undesirable PD properties of a
substance that may have relevance to its human
Drug Development Safety safety.
Pharmacology Study 2) To evaluate adverse PD and/or pathophysio effects
Objectives (3) of a substance observed in toxicology studies
3)to investigate the mechanism of the adverse PD
effects observed and/or suspected
Three vital organ 1) Cardiovascular
considered highest 2)Respiratory
priority 3)CNS
1) PK and toxicokinetic
2) Single dose toxicity
3) Repeated dose toxicity
Types of Non-Clinical 4) Local tolerance
Studies (Animal Trials) 5) Genotoxicity
6) Carcinogenicity
7) Reproduction toxicity
8) Supplemental studies if needed
Study that investigates the mode of action and/or
Primary
effects of a drug substance in relation to its desired
Pharmacodynamic Studies
therapeutic target
Studies that investigate the mode of action and/or
Secondary
effects of a drug substance not related to its desire
Pharmacodynamic Studies
therapeutic target
Blood Pressure
Core Battery for Heart Rate
Cardiovascular System ECG/EKG
Repolarization/conductance abnormalities
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