Expedited review - Study guides, Class notes & Summaries

ACRP CCRC Exam Review (Latest 2024/ 2025 Update) Questions and Verified Answers| 100% Correct| Grade A Q: When is an AE considered an ADR? Answer: In pre-approved clinical settings 1. Either a new med product OR existing med product with new usages 2. Must be causal relationship In post-marketed products 1. noxious & unintended response to a drug that occurs at normal doses Q: What is an unexpected ADR? Answer: ADR that is not consistent in nature and/or severity wi...

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...

1A protocol that has been previously reviewed by the full IRB is always eligible for expedited review. A. TRUE B. FALSE - Answer-B. FALSE 1A serious adverse event (SAE) should be reported to the local IRB within what period of time after learning of the event? A. 5 days B. 2 weeks C. 24 hours D. Follow the local IRB reporting guidelines. - Answer-D. Follow the local IRB reporting guidelines. 1Essential documents collected for research projects may be audited or inspected for GCP complia...

The Federal Regulations – SBE Questions and Answers Rated A+ What does the Common Rule regulate in research involving human subjects? The Common Rule regulates the ethical standards and procedures for protecting human subjects in federally funded research. What is the role of an Institutional Review Board (IRB) in research? An IRB reviews and oversees research to ensure it meets ethical guidelines and protects the rights of human subjects. Which federal regulation requires resear...

MISSOURI LIFE AND HEALTH EXAM 2024/2025 In a Life insurance contract, an insurance company's promise to pay stated benefits is called the: a) insuring clause b) consideration clause c) entire contract d) owner's rights - Precise Answer insuring clause under which circumstance MUST a health insurer have an expedited grievance review procedure? - Precise Answer when the enrollee's life or health is jeapordized The Consideration clause in a life insurance contract contains what p...

ACRP CCRC Exam (Latest 2024/ 2025 Update) Questions and Verified Answers| 100% Correct| Grade A Q: Which of the following is an unexpected adverse event? a) A report which adds significant information to an already documented serious adverse event b) A report of interstitial nephritis in a patient with acute renal failure c) A report of fulminant hepatitis in patient with an initial report of hepatitis d) All of the above Answer: d) All of the above Q: For expedited reportin...

NR449/ NR 449 Evidence Based Practice (New 2024/ 2025 Update) Questions and Verified Answers| 100% Correct| A Grade -Chamberlain QUESTION Deception or incomplete disclosure is allowed in research under all of the following conditions, except a. no other nondeceptive method exists b. the study will make a substantial contribution to the body of knowledge c. there is a plan to debrief the subjects regarding the deception d. Subjects are unable to give informed consent Answer: D ...

IRB Review Questions Correctly Answered. A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence? - CORRECT ANSWER Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB. The most appropriate action for the investigator to take...

SOCIAL & BEHAVIORAL RESEARCH - BASIC/REFRESHER COMPLETE 100+ WRITTEN QUESTIONS AND ANSWERS ALL DONE PRACTICE UPDATE Which of the following are the three principles discussed in the Belmont Report? A. Respect for Persons, Beneficence, Justice B. Informed Consent, Institutional Assurance, Researcher Responsibility C. Privacy, Confidentiality, Equitable Selection of Subjects D. IRB Review, Federal Regulations, Declaration of Helsinki The Belmont Report's principle of respect fo...

The belmont report was formulated by? - Correct Answer The National Commission for the protection of human subjects in biomedical and behavioral research The revised common rule revised - Correct Answer 45 CFR 46 Subpart A HHS certification Institution Responsibilities - Correct Answer The Institution bears full responsibility for all research involving human subjects covered under its Assurance. For all HHS-conducted or supported research, all of the requirements of the HHS Regulations at...