CCRP SoCRA Exam

21 CFR Part 11 - Answer- Electronic Records; Electronic Signatures 21 CFR Part 11 Subpart B - Answer- Electronic Records 21 CFR Part 11 Subpart C - Answer- Electronic Signatures 21 CFR Part 50 - Answer- Protection of Human Subjects 21 CFR Part 50 Subpart B - Answer- Informed Consent of Human Subjects 21 CFR Part 50 Subpart D - Answer- Additional Safeguards for Children in Clinical Investigations 21 CFR Part 56 - Answer- Institutional Review Board 21 CFR Part 56 Subpart B - Answer- Organization and Personnel 21 CFR Part 56 Subpart C - Answer- IRB Functions and Operations 21 CFR Part 56 Subpart D - Answer- IRB Records and Reports 21 CFR Part 56 Subpart E - Answer- Administrative Actions for Noncompliance 21 CFR Part 312 - Answer- Investigational New Drug Application 21 CFR Part 312 Subpart B - Answer- Investigational New Drug Application (IND) 21 CFR Part 312 Subpart C - Answer- Administrative Actions 21 CFR Part 312 Subpart D - Answer- Responsibilities of Sponsors and Investigators 21 CFR Part 312 Subpart E - Answer- Drugs Intended to Treat Life-Threatening and Severely-Debilitating Illnesses 21 CFR Part 312 Subpart F - Answer- Miscellaneous 21 CFR Part 312 Subpart I - Answer- Expanded Access to Investigational Drugs for Treatment Use 21 CFR Part 812 - Answer- Investigational Device Exemptions 21 CFR Part 812 Subpart B - Answer- Application and Administrative Action