Ccrp test questions - Study guides, Class notes & Summaries

CCRP SoCRA Exam Latest Update Rated A 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 Subpa...

Year/ description of the Nuremberg Code - 1947- German physicians conducted unethical experiments on concentration camp prisoners without their consent. What implications came of the Nuremberg Code? - Ten elements of human research including voluntary informed consent is absolutely essential. Year and description of the Declaration of Helsinki - 1964- Based on the principles of the Nuremberg code. This declaration laid out principles for PHYSICIANS to follow. First significant eff...

CCRP Test Questions with Correct Answers SAE - Answer-Serious Adverse Event: - results in death - is life threatening (patient was at risk of death at time of the event) - results in persistent or significant disability - congenital anomaly/birth defect Short Form - Answer-A document that states that the elements of informed consent have been presented orally to and understood by the participant or the participant's LAR. 4 components of short form - Answer-1. A short form consent ...

Socra CCRP test questions and answers

Contract Research Organization - A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. When a short form is used for informed consent the witness must sign the short form or the summary? - False-they must sign both What is FDA form 3454 - Certification Financial Interests and Arrangements of Clinical Investigators What are the three main basic ethical principles of the B...

CCRP SOCRA Exam - Practice Exam #1 (Practice Test #1 (Ethics, 21 CFR Parts 50, 56, 312, 812; 45 CFR Part 46) Past questions directly from SOCRA) Passed Qs & As