CCRP 2023 Exam Questions with Correct Answers

CCRP 2023 Exam Questions with Correct Answers 21 CFR 11 - Answer-Electronic Records; Electronic Signatures B - Electronic Records C - Electronic Signatures 21 CFR 50 - Answer-Protection of Human Subjects/Informed Consent B - Informed Consent 50.23 - Exception from General 50.24 - Exception from Informed Consent Requirements for Emergency Research 50.25 - Elements of Informed Consent 50.27 - Documentation of Informed Consent D - Additional Safeguards for Children 21 CFR 50 Subpart B - Answer-50.25 Elements of Informed Consent 21 CFR 50 Subpart D - Answer-Additional Safeguards for Children 21 CFR 54 - Answer-Financial Disclosure by Clinical Investigators 21 CFR 56 - Answer-Institutional Review Boards B - Organization and Personnel 56.106 - Registration 56.107 - Membership C - Functions & Operations 56.108 - Functions & Operations D - Records/Reports 56.115 - IRB Records 21 CFR 56 Subpart B - Answer-Organization & Personnel 56.106 - Registration 56.107 - Membership 21 CFR 56 Subpart C - Answer-Functions & Operations 56.108 - Functions/Operations 21 CFR 312 - Answer-Investigational New Drug Application B - Investigational New Drug Application D - Responsibilities of Sponsors & Investigators E - Drugs Intended to Treat Life-Threatening and Severely Debilitating Illnesses I - Expanded Access to Investigational Drugs for Treatment Use 21 CFR 812 - Answer-Investigational Device Exemptions 45 CFR 46 - Answer-Public Welfare (Common Rule) A - Basic HHS Policy for Protection of Human Research Subjects 46.116 - General Requirements for Informed Consent 46.117 - Documentation of Informed Consent