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