Irb member - Study guides, Class notes & Summaries

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, safety, or welfare of a subject B) Purported or represented to be for a u...

Which of the following constitutes both a breach of confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)? - ANSWER-A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified. The IRB Admin...

Minimal Risk - Correct Answer The probability of harm or discomfort...not greater...than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations. The Belmont Principles - Correct Answer Respect for persons, beneficence, and justice IRB - Correct Answer An administrative body composed of scientists and nonscientists established to protect the rights and welfare of human research subjects recruited to participate in research acti...

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, safety, or welfare of a subject B) Purported or represented to be for a use in ...

According to the Belmont Report, respect for persons usually demands that subjects... : enter into research voluntarily & with adequate information According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of: : Justice A poorly designed protocol is considered unethical because... : research subjects may be put at risk or inconvenienced for insufficient reason When should an IRB suspend or terminate a...

CCRP SOCRA Exam - Practice Exam 1 with Complete Solutions NB: Answers to questions appear at the bottom of the choices and are highlighted in yellow 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...

IRB and IACUC Questions and Answers with Verified Solutions 21 CFR 50 and 56 regulate A.) Animal research B.) Exempted research C.) non-consent research D.) Research regulated by the FDA D.) Research regulated by the FDA 45 CFR 46 is also known as A.) the Golden Rule B.) the common rule C.) the consent form D.) none of the above B.) the common rule A human research protocol must go through full committee review if it involves "vulnerable" populations. Which of the followin...

MEGA SOCRA CCRP EXAM CONTENT REVIEW PRACTICE TEST. 5 - correct answer The minimum number of IRB members Subjects cannot be enrolled until IRB/IEC approval has been obtained - correct answer In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval? The Sponsor - correct answer The responsibility for ensuring that the investigator understands a clinical trial lies with: A subject has been enrolled on a ...

CCRC Exam Questions and Answers Latest Updated 2024 (GRADED A+) Adverse Drug Reaction (ADR) Correct Answer: All noxious and unintended responses to a medicinal product related to any dose E6(R1) 1 Correct Answer: Glossary of terms Adverse Event (AE) Correct Answer: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment--any unfavorable and unintended si...

SoCRA Certification Exam 2023 with complete answers Biometrics A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable. (21 CFR, Sec. 11.3) Closed System An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec. 11.3) Digi...