CCRP SoCRA Exam Questions with 100% Correct Solutions Graded to PASS

21 CFR Part 11 Electronic Records; Electronic Signatures 21 CFR Part 11 Subpart B Electronic Records 21 CFR Part 11 Subpart C Electronic Signatures 21 CFR Part 50 Protection of Human Subjects 21 CFR Part 50 Subpart B Informed Consent of Human Subjects 21 CFR Part 50 Subpart D Additional Safeguards for Children in Clinical Investigations 21 CFR Part 56 Institutional Review Board 21 CFR Part 56 Subpart B Organization and Personnel 21 CFR Part 56 Subpart C IRB Functions and Operations 21 CFR Part 56 Subpart D IRB Records and Reports 21 CFR Part 56 Subpart E Administrative Actions for Noncompliance 21 CFR Part 312 Investigational New Drug Application 21 CFR Part 312 Subpart B Investigational New Drug Application (IND) 21 CFR Part 312 Subpart C Administrative Actions 21 CFR Part 312 Subpart D Responsibilities of Sponsors and Investigators 21 CFR Part 312 Subpart E Drugs Intended to Treat Life-Threatening and Severely-Debilitating Illnesses 21 CFR Part 312 Subpart F Miscellaneous 21 CFR Part 312 Subpart I Expanded Access to Investigational Drugs for Treatment Use 21 CFR Part 812 Investigational Device Exemptions 21 CFR Part 812 Subpart B Application and Administrative Action 21 CFR Part 812 Subpart C Responsibilities of Sponsors 21 CFR Part 812 Subpart D IRB Review and Approval 21 CFR Part 812 Subpart E Responsibilities of Investigators 21 CFR Part 812 Subpart G Records and Reports 45 CFR Part 46 Protection of Human Subjects 45 CFR Part 46 Subpart A Basic HHS Policy for Protection of Human Subjects 45 CFR Part 46 Subpart B Additional Protections for Pregnant Women, Human Fetuses, and Neonates Involved in Research 45 CFR Part 46 Subpart C Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects 45 CFR Part 46 Subpart D Additional Protections for Children Involved as Subjects in Research 45 CFR Part 46 Subpart E Registration of Institutional Review Boards Conditions for Expedited Review 1. No more than minimal risk 2. Minor changes in previously approved research 21 CFR Part 56.110 General Responsibilities of Sponsor (IND) 21 CFR Part 312.50 1. Selecting qualified investigators 2. Proving investigator with information to conduct a trial properly 3. Ensure proper monitoring of the trial 4. Ensuring investigation is conducted in accordance with protocol in the IND 5. Maintaining an effective IND 6. Ensuring FDA and all investigators are promptly informed of significant new adverse effects or risks of the drug