SOCRA CCRP EXAM(ACTUAL EXAM) WITH
CORRECT 60+ QUESTIONS AND ANSWERS
LATEST 2024 – 2025 GOOD SCORE IS
GUARANTEED GRADE A+
Investigational agreement - ANSWERS-What is used in device studies
instead of a 1572?
5 Working Days, IRB and sponsor - ANSWERS-What time frame and to
whom do sites have to report deviations from investigational plan in
order to protect life or well being of patients on device trials?
10 Working Days, Sponsor and reviewing IRB - ANSWERS-What
timeframe and to whom do investigators have to report UADEs?
April 30 1996 - ANSWERS-ICH GCP Development Date
,Quality - ANSWERS-ICH Q
Efficacy - ANSWERS-ICH E
Safety - ANSWERS-ICH S
Multidisciplinary - ANSWERS-ICH M
guidance for industry, consolidated guideance - ANSWERS-ICH E 6
Clinical Safety Data Management Definitions and Standards -
ANSWERS-ICH E2A
Safety pharmacology studies for human pharmaceuticals - ANSWERS-
ICH S7A
Electronic records, electronic signatures - ANSWERS-21 CFR Part 11
Informed Consent - ANSWERS-21 CFR Part 50
,Financial Disclosures - ANSWERS-21 CFR Part 54
Institutional Review Board - ANSWERS-21 CFR Part 56
21 CFR Part 814 - ANSWERS-pre market approval of medical devices
45 CFR Part 46 - ANSWERS-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 - ANSWERS-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 - ANSWERS-Drug Development Safety Pharmacology
Study Objectives (3)
1) Cardiovascular
2)Respiratory
3)CNS - ANSWERS-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 - ANSWERS-Types of Non-Clinical
Studies (Animal Trials)
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