Clinical trial protocol - Study guides, Class notes & Summaries

ACRP CCRC Exam Prep Questions and answers 100% correctWhat are expected or possible consequences of over-estimation of recruitment potential? - The trial will overrun its projected timeline - The recruitment period will be prolonged and more sites may be needed - The study will not have sufficient data within the required timeframe and will be stopped because of lack of budget What should be the first consideration when conducting a clinical trial? Subject welfare When is the i...

The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that: - Persons with diminished autonomy are entitled to protection. Which of the following are the three principles discussed in the Belmont Report? - Respect for Persons, Beneficence, Justice Which of the following is an example of how the principle of beneficence can be applied to a study employing human subject...

Test Bank Varcarolis Foundation Of Psychiatric Mental health Nursing 8th Edition By Marget Jordan Halter || All Chapters ( 1-36) || Updated Version 2024 A++ Varcarolis‘ Foundations of Psychiatric Mental Health Nursing: A Clinical Approach, 8th Edition Halter: Varcarolis’ Foundations of Psychiatric Mental Health Nursing: A Clinical Approach, 8th Edition A+ Varcarolis‘ Foundations of Psychiatric Mental Health Nursing: A Clinical Approach, 8th Edition UNIT I: FOUNDATIONS IN THEORY 1...

According to ICH GCP what are the absolute minimum requirements for essential documents at site before IMP can be sent to the site? a. CV of investigator and Clinical Trial Authorization (CTA) b. Ethics Committee Approval and signed protocol c. CTA and Ethics Committee Approval d. CTA, Ethics Committee Approval and signed protocol CORRECT ANSWER c. CTA and Ethics Committee Approval What C is missing from this statement in ICH GCP: The sponsor should provide insurance or should indemnify...

Good Clinical PracticeWhich of the following are the three principles included in the Belmont Report? - correct answer • Respect for Persons • Beneficence • Justice Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects? - correct answer • Determining that the study has maximized benefits and minimized risks. * The Belmont Report's principle of beneficence includes the two general rules as complementary expres...

Varcarolis‘ Foundations of Psychiatric Mental Health Nursing: A Clinical Approach, 8th Edition Halter: Varcarolis’ Foundations of Psychiatric Mental Health Nursing: A Clinical Approach, 8th Edition A+ Varcarolis‘ Foundations of Psychiatric Mental Health Nursing: A Clinical Approach, 8th Edition UNIT I: FOUNDATIONS IN THEORY 1. Mental Health and Mental Illness 2. Theories and Therapies 3. Psychobiology and Psychopharmacology UNIT II: FOUNDATIONS FOR PRACTICE 4. Treatment Settings 5. Cultura...

Which of the following required elements should be included in a clinical trial protocol?

CITI Training 134 QUESTIONS Graded A+ Solved 2023 What must you file before conducting human clinical trials with an experimental drug? Correct Answer: IND application (Form FDA 1571) During the clinical development phase of the IND process, what must sponsors do? Correct Answer: Maintain current IND application by amending IND with new Form FDA 1571 and providing FDA with: safety updates copies of new protocols FDA 1572 Annual Progress reports this document notifies FDA of relevant...

ACRP CCRC Study Guide (Latest 2024/ 2025 Update) Questions and Verified Answers| 100% Correct| Grade A Q: "Approval" (in relation to Institutional Review Boards) Answer: The affirmative de- cision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements. Q: Audit Answer: A systematic and independent exa...

What would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial? -Correct Answer Try to obtain the subject's reason for withdrawal. CRO recently switched from paper CRF to an EDC system. The EDC system must conform to the established requirements for -Correct Answer Validation Accuracy Reliability Completeness Part of a sponsor's responsibility pertaining to electronic trial data handling is to -Correct Answer maintain an audit tra...