21cfr50 subpart b - Study guides, Class notes & Summaries

CCRP SOCRA Exam - Practice Exam #1 Questions and Answers 2023 The responsibility for ensuring that the investigator understands a clinical trial lies with which individual/or organization? A) FDA B) IRB C) Sponsor D) Coordinator C) Sponsor What is the minimum number of IRB Members? A) 3 B) 5 C) 6 D) 10 B) 5 A significant risk device is defined as an investigational device that is: A) Intended as an implant and presents a potential for serious risk to the health, s...

CCRP SOCRA Exam test preparation Questions and Must have marking scheme Updated version 2024/2025 This form is used for the voluntary reporting of adverse events and product problems: A) 1571 B) 1572 C) 3500 D) 3500A - correct answer C) 3500 Reminder: 3500 is for voluntary; 3500A is for mandatory Each IRB that reviews studies involving children as subjects is covered by: A) 21CFR Part 56, Sub part A B) 21CFR Part 56, Sub part B C) 21CFR Part 50, Sub part C D) 21CFR Part 56, ...

SOCRA CCRP Exam Practice Test Questions With Complete Solutions 21 CFR part 11 regulates? - ANSWER Electronic Signatures What is the name of FDA Form 483? - ANSWER Inspectional Observation What does 21CFR56 regulate? - ANSWER Institutional Review Boards An application for Investigational Device Exemption is part of 21 CFR part ____________? - ANSWER 812 Define Electronic Signature - ANSWER A computer data compilation of any symbol or series of symbols executed, ...

SOCRA Practice 1 questions and answers latest 2023 True or False The terms "treatment protocol" and "treatment IND" are interchangeable and mean the same thing. False. A treatment protocol is sponsored by a sponsor, while a treatment IND (Investigational New Drug) is sponsored by a licensed medical practitioner who becomes a sponsored investigator. 21 CRF 312.35 True or False Investigators are responsible for periodically requesting updates regarding new information gleaned by a ...

SOCRA- 2023 100% accurate answers Belmont Report was created as part of? The national Research Act of 1974. Who was the Belmont Report formulated by? The National Commission for the protection of human subjects in biomedical and behavioral research. What year was the publication of the FDA regulations made? 1980 *1981 for the HHS and revised FDA Regulations. What year was GCP and HIPAA created? 1996 What is the National Research Act? A set of regulations for the...