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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)
Dose Escalation (tolerance)
Crossover (Bioequivalence)
Parallel Group (efficacy and safety)
5 Common Study Designs
Dose Range (Multiple doses, usually placebo
controlled)
Uncontrolled (Long term expansion studies)
21 CFR 312 IND Application
21 CFR 312.60-70 Investigator Responsibilities
21 CFR 314 New Drug Application
21 CFR 812 Investigational Device Exemption
21 CFR Part 11 Electronic records, electronic signatures
21 CFR Part 50 Informed Consent
21 CFR Part 50 only The subject only
requires who to sign the
ICF?
21 CFR Part 54 Financial Disclosures
21 CFR Part 56 Institutional Review Board
Maintain adequate and accurate records
21 CFR Part 312.62
Investigator responsibilitiy
21 CFR Part 312.68 Make study records available for inspection
21 CFR Part 803 Medical Device Reporting
, 21 CFR Part 812 Investigational Device Exemption
21 CFR Part 814 Premarket Approval of Medical Devices
21 CFR Part 820 Quality System Regulations
21 CFR Part 860 Medical Device Classification Procedures
45 CFR Part 46 HHS Regulations for Protection of Human Subjects
Amendments to IND with Build logically on previous submissions
new or revised protocols Be supported by additional information such as
(21 CFR Part 312) animal studies and other human studies
Before clinical trials can Investigational New Drug Application
be initiated, an application FDA
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)
1) Are usually those that support or sustain human life
2) are of substantial importance in preventing the
Class III Devices
impairment of human health
Descriptions
3)Present a potential, unreasonable risk of illness or
injury
Not less than once a year
Continuing review must be
Appropriate for the risk involved
conducted how often?
Review must be done prior to current expiration
Blood Pressure
Core Battery for Heart Rate
Cardiovascular System ECG/EKG
Repolarization/conductance abnormalities
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