Ccrp test - 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...

AACVPR CCRP Exam Test Bank with Verified Answers | Latest 2023/2024 Polyphenols ️ antioxidants flavonoids are most abundant polyphenols in our diet Phytosterols ️ Naturally occurring sterols found in plants. Phytosterols lower LDL cholesterol levels by competing with cholesterol for absorption in the intestinal tract. Sterols added to milk, margarine, orange juice, olive oil, cheese, bread fruits and vegetable ️ improve lipids, inflammation, and endothelial function nuts ️ high ...

CCRP Timelines Review Test Q & A. 5 Working Days Report to FDA - correct answer Notice of change to the IDE 5 Working Days Report to FDA, Investigators and IRBs - correct answer Termination of study after determination due to a UADE that presents an unreasonable risk 5 working days to Sponsor - correct answer Investigator to notify sponsor regarding IRB withdrawal of approval 5 Working Days to FDA, Other participating IRBs and PIs - correct answer Sponsor to notify all other IRBs and P...

SoCRA CCRP Test Exam Review Questions with all Answers verified for accuracy Updated 2024/2025 Viable - correct answer as it pertains to the neonate, means being able after delivery to survive. Human Subject - correct answer A living individual about whom an investigator conducting research obtains 1)Data through intervention or interaction with the individual 2) Identifiable private information. (45 CFR, sec. 46.102) Certification - correct answer The official notification by the insti...

Contract Research Organization - ANSWER 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? - ANSWER False-they must sign both What is FDA form 3454 - ANSWER Certification Financial Interests and Arrangements of Clinical Investigators

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 ...