Irb practice test - Study guides, Class notes & Summaries

RAC Practice Exam Questions and Answers Rated A+ A physician reports to a manufacturer that a patient was hospitalized with acute sepsis after treatment with an approved device. This side effect is not listed in the package insert. This event must be reported by the manufacturer to FDA no later than: A. 5 calendar days. B. 15 calendar days. C. 30 calendar days. D. The next quarterly or annual report. C. 30 calendar days. Serious injury must be reported within 30 days. 21 CFR 803.50(a). Und...

CITI Modules Review Practice Test. 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: - CORRECT ANSWER Persons with diminished autonomy are entitled to protection. Which of the following are the three principles discussed in the Belmont Report? - CORRECT ANSWER Respect for Persons, Beneficence, Justice Which of the following is an example of how the prin...

Which of the following is a disclosure of financial interests form? FDA Form 3455 Which of the following is a certification of financial interest form? FDA Form 3454 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: FDA Form 3455 This form is submitted by sponsor to the FDA prior to the beginning of the drug trial Investigational New Drug Application (1571) In the top right corner, form have OMB number. Wh...

What is the minimal grade to pass? - Answer-77C ULL department of nursing missions statement - Answer-to seek to promote, expand & validate scientific knowledge & evidence-based practice to advance health & provide an atmosphere of scholarly inquiry, an appreciation of professional values, inter-professional collaboration & active community service What happens if you miss a test? - Answer-will receive an unexcused absence and grade 0 What is required if you are applying for your first clin...

ACRP EXAM PRACTICE WITH COMPLETE SOLUTIONS LATEST 2023/2024 GRADED A+. What needs reported to the IRB? - Answer *Changes / deviations from protocol due to unforeseen hazard * changes to subject risk * adverse events * new info that may impact subject safety Payment to subjects must be.... - Answer prorated & not contingent on subject completing study Investigator Responsibilities - Answer *Maintain delegation long *Ensure staff are trained/informed about the protocol (give delegated task...

RAC Practice Exam 1 Questions and Answers New Version 2024 Complete Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic records and electronic signatures)? A Manually generated timestamped audit trails to record the date and time of operator entries and actions that create, modify or delete electronic records. B Validation of systems to ensure accuracy C Authority checks to ensure that only authorized personell can create, modify or delete electronic re...

CCRP Final Exam Study Guide Practice Questions. Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the: - correct answer PI and Sponsor. In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? - correct answer The subject's legally acceptable representative Which of the following required elements should be included in a clinical trial protocol? - correct answer The subject inclusion and e...

CCRP Practice Questions | 100% Correct Answers | Verified | Latest 2024 Version Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the: - PI and Sponsor. In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? - The subject's legally acceptable representative Which of the following required elements should be included in a clinical trial protocol? - The subject inclusion and exclusion c...

US RAC Review Questions RAPS Modules With Complete Solutions Latest 2023/2024 (100% Verified). drug, which of the following studies would typically be conducted first: A) 1 month repeat dose toxicology study B) Single dose escalation PK study in healthy volunteers C) Multiple dose PK study in healthy volunteers D) Single dose escalation study in hypertensive patients:  B) Single dose esca- lation PK study in healthy volunteers 3. A sponsor must report an unexpected, fatal or life...

RAC Practice Exam 1 Latest 2024 with complete solution Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic records and electronic signatures)? A Manually generated timestamped audit trails to record the date and time of operator entries and actions that create, modify or delete electronic records. B Validation of systems to ensure accuracy C Authority checks to ensure that only authorized personell can create, modify or delete electronic records. D Est...