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SoCRA (Actual Exam Graded A+)
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Electronic Records, Electronic Signatures - ANSWER CFR Title 21: Part 11 Informed Consent - ANSWER CFR Title 21: Part 50 Financial Disclosure - ANSWER CFR Title 21: Part 54 Instiutional Review Board - ANSWER CFR Title 21: Part 56 Investigational new Drug Application - ANSWER CFR Title 2...

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  • September 30, 2022
  • 4
  • 2022/2023
  • Exam (elaborations)
  • Questions & answers

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  • SoCRA
  • SoCRA

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SoCRA
Electronic Records, Electronic Signatures - ANSWER CFR Title 21: Part 11
Informed Consent - ANSWER CFR Title 21: Part 50
Financial Disclosure - ANSWER CFR Title 21: Part 54
Instiutional Review Board - ANSWER CFR Title 21: Part 56
Investigational new Drug Application - ANSWER CFR Title 21: 312
New Drug Application - ANSWER CFR Title 21: 314
Investigational Device Exemption - ANSWER CFR Title 21: 812
Pre- Market Approval of Medical Devices - ANSWER CFR Title 21: 814
Protection of Human Subjects - ANSWER CFR Title 45 Part 46
Notice of Inspection - ANSWER Form 482
Inspectional observations - ANSWER Form 483
Statement from the Investigator - ANSWER Form 1572
Certification of Financial Interests - ANSWER Form 3454
Disclosure of Financial Interests - ANSWER Form 3455
Voluntary Adverse Events - ANSWER Form 3500
Mandatory Adverse Events - ANSWER Form 3500A
Cover sheet for IND - ANSWER Form 1571
Protection of Human Subjects, "the Common Rule" - ANSWER CFR Title 45 Part 46
Pregnant Women and Fetuses - ANSWER CFR Title 45 Part 46 - Part B
Prisoners - ANSWER CFR Title 45 Part 46 - Part C
Children - ANSWER CFR Title 45 Part 46 - Part D

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