Clinical trial protocol - Study guides, Class notes & Summaries

ACRP Exam (Latest 2024/ 2025 Update) Questions and Verified Answers| 100% Correct| Grade A Q: To be a qualifying clinical trial, which three requirements must be met? a. the trial has therapeutic intent, has an investigational new drug number, and enrolls patients with diagnosed disease b. the trial has therapeutic intent, enrolls patients with diagnosed disease and evaluates an item/service that falls within a medicare benefit category c. the trial has therapeutic intent, has an investi...

Certification for IRB Professionals (CIP) Exam Complete Q&A 2023. According to the Belmont Report, respect for persons usually demands that subjects... According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of: - A poorly designed protocol is considered unethical because... - When should an IRB suspend or terminate approval of research? - A quorum for a convened IRB meeting requires the pr...

Chapter 01: Using Evidence in Nursing Practice Perry et al.: Clinical Nursing Skills & Techniques, 10th Edition MULTIPLE CHOICE 1. Evidence-based practice is a problem-solving approach to making decisions about patient care that is grounded in: a. the latest information found in textbooks. b. systematically conducted research studies. c. tradition in clinical practice. d. quality improvement and risk-management data. ANS: B The best evidence comes from well-designed, systematically con...

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 study and was randomized to the non-treatment arm. T...

Test Bank For Varcarolis' Foundations of Psychiatric-Mental Health Nursing 9th Edition By Margaret Jordan Halter (COMPLETE CHAPTER 1-36 LATEST UPDATE) ...

Which of the following was the result of the Beecher article? - Answer- Realization that ethical abuses are not limited to the Nazi regime Issued in 1974, 45 CFR 46 raised to regulatory status: - Answer- US Public Health Service Policy The use of prisoners in research is a concern under the Belmont principle of Justice because: - Answer- Prisoners may not be used to conduct research that only benefits the larger society Which of the following is included in the Nuremberg Code: - Answer-...

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...

WGU C426 Healthcare Values and Ethics Rated A+ Normative Ethics Attempt to determine what moral standards should be followed so that human behavior and conduct may be morally right. Consequential Ethics Theory of ethics emphasizes that the morally right action is whatever action leads to the maximum balance of good over evil. - What will be the effects of each course of action? - Will they be positive or negative? - Who will benefit? - What will do the least harm? Utilitarian Ethics The conce...

Treatment Emergent -Correct Answer An event that emerges during treatment having been absent pre-treatment, or worsens relative to the pre-treatment state. treatment effect -Correct Answer An effect attributed to a treatment in a clinical trial. In most clinical trials the treatment effect of interest is a comparison (or contrast) of two or more treatments. Surrogate Variable -Correct Answer A variable that provides an indirect measurement of effect in situations where direct measurement o...

Practice Questions for SOCRA exam VERIFIED 2022/2023Which of the following is a disclosure of financial interests form? ... Which of the following is a certification of financial interest form? ... 00:27 01:29 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: ... This form is submitted by sponsor to the FDA prior to the beginning of the drug trial Investigational New Drug Application In the top rig...