CCRP SoCRA Exam with all Correct & 100% Verified Answers |
Latest Version |Already Graded A+
1. 21 CFR Part 11 Electronic Records; Electronic Signatures
2. 21 CFR Part 11 Subpart B Electronic Records
3. 21 CFR Part 11 Subpart C Electronic Signatures
4. 21 CFR Part 50 Protection of Human Subjects
5. 21 CFR Part 50 Subpart B Informed Consent of Human Subjects
6. 21 CFR Part 50 Subpart D Additional Safeguards for Children in Clinical Investigations
7. 21 CFR Part 56 Institutional Review Board
8. 21 CFR Part 56 Subpart B Organization and Personnel
9. 21 CFR Part 56 Subpart C IRB Functions and Operations
10. 21 CFR Part 56 Subpart D IRB Records and Reports
11. 21 CFR Part 56 Subpart E Administrative Actions for Noncompliance
12. 21 CFR Part 312 Investigational New Drug Application
13. 21 CFR Part 312 Subpart B Investigational New Drug Application (IND)
14. 21 CFR Part 312 Subpart C Administrative Actions
15. 21 CFR Part 312 Subpart D Responsibilities of Sponsors and Investigators
16. 21 CFR Part 312 Subpart E Drugs Intended to Treat Life-Threatening and Severely-
Debilitating
Illnesses
17. 21 CFR Part 312 Subpart F Miscellaneous
18. 21 CFR Part 312 Subpart I Expanded Access to Investigational Drugs for Treatment Use
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, CCRP SoCRA Exam with all Correct & 100% Verified Answers |
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19. 21 CFR Part 812 Investigational Device Exemptions
20. 21 CFR Part 812 Subpart B Application and Administrative Action
21. 21 CFR Part 812 Subpart C Responsibilities of Sponsors
22. 21 CFR Part 812 Subpart D IRB Review and Approval
23. 21 CFR Part 812 Subpart E Responsibilities of Investigators
24. 21 CFR Part 812 Subpart G Records and Reports
25. 45 CFR Part 46 Protection of Human Subjects
26. 45 CFR Part 46 Subpart A Basic HHS Policy for Protection of Human Subjects
27. 45 CFR Part 46 Subpart B Additional Protections for Pregnant Women, Human Fetuses,
and
Neonates Involved in Research
28. 45 CFR Part 46 Subpart C Additional Protections Pertaining to Biomedical and
Behavioral Re-
search Involving Prisoners as Subjects
29. 45 CFR Part 46 Subpart D Additional Protections for Children Involved as Subjects in
Research
30. 45 CFR Part 46 Subpart E Registration of Institutional Review Boards
31. Conditions for
Expedited Review 1. No more than minimal risk
2. Minor changes in previously approved
research 21 CFR Part 56.110
32. General Responsibilities
of Sponsor (IND)
1. Selecting qualified investigators
21 CFR Part 312.50
2. Proving investigator with information to conduct a trial
properly
3. Ensure proper monitoring of the trial
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16
, CCRP SoCRA Exam with all Correct & 100% Verified Answers |
Latest Version |Already Graded A+
4. Ensuring investigation is conducted
in accordance with protocol
3/
16
Latest Version |Already Graded A+
1. 21 CFR Part 11 Electronic Records; Electronic Signatures
2. 21 CFR Part 11 Subpart B Electronic Records
3. 21 CFR Part 11 Subpart C Electronic Signatures
4. 21 CFR Part 50 Protection of Human Subjects
5. 21 CFR Part 50 Subpart B Informed Consent of Human Subjects
6. 21 CFR Part 50 Subpart D Additional Safeguards for Children in Clinical Investigations
7. 21 CFR Part 56 Institutional Review Board
8. 21 CFR Part 56 Subpart B Organization and Personnel
9. 21 CFR Part 56 Subpart C IRB Functions and Operations
10. 21 CFR Part 56 Subpart D IRB Records and Reports
11. 21 CFR Part 56 Subpart E Administrative Actions for Noncompliance
12. 21 CFR Part 312 Investigational New Drug Application
13. 21 CFR Part 312 Subpart B Investigational New Drug Application (IND)
14. 21 CFR Part 312 Subpart C Administrative Actions
15. 21 CFR Part 312 Subpart D Responsibilities of Sponsors and Investigators
16. 21 CFR Part 312 Subpart E Drugs Intended to Treat Life-Threatening and Severely-
Debilitating
Illnesses
17. 21 CFR Part 312 Subpart F Miscellaneous
18. 21 CFR Part 312 Subpart I Expanded Access to Investigational Drugs for Treatment Use
1/
16
, CCRP SoCRA Exam with all Correct & 100% Verified Answers |
Latest Version |Already Graded A+
19. 21 CFR Part 812 Investigational Device Exemptions
20. 21 CFR Part 812 Subpart B Application and Administrative Action
21. 21 CFR Part 812 Subpart C Responsibilities of Sponsors
22. 21 CFR Part 812 Subpart D IRB Review and Approval
23. 21 CFR Part 812 Subpart E Responsibilities of Investigators
24. 21 CFR Part 812 Subpart G Records and Reports
25. 45 CFR Part 46 Protection of Human Subjects
26. 45 CFR Part 46 Subpart A Basic HHS Policy for Protection of Human Subjects
27. 45 CFR Part 46 Subpart B Additional Protections for Pregnant Women, Human Fetuses,
and
Neonates Involved in Research
28. 45 CFR Part 46 Subpart C Additional Protections Pertaining to Biomedical and
Behavioral Re-
search Involving Prisoners as Subjects
29. 45 CFR Part 46 Subpart D Additional Protections for Children Involved as Subjects in
Research
30. 45 CFR Part 46 Subpart E Registration of Institutional Review Boards
31. Conditions for
Expedited Review 1. No more than minimal risk
2. Minor changes in previously approved
research 21 CFR Part 56.110
32. General Responsibilities
of Sponsor (IND)
1. Selecting qualified investigators
21 CFR Part 312.50
2. Proving investigator with information to conduct a trial
properly
3. Ensure proper monitoring of the trial
2/
16
, CCRP SoCRA Exam with all Correct & 100% Verified Answers |
Latest Version |Already Graded A+
4. Ensuring investigation is conducted
in accordance with protocol
3/
16
