21 cfr part 11 subpart b - Study guides, Class notes & Summaries

SOCRA Practice Test questions and answers with complete top solutions 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 Appl...

CCRP SOCRA Exam VERIFIED CFR Part 11 Electronic Records; Electronic Signatures 21 CFR Part 11 Subpart B Electronic Records 21 CFR Part 11 Subpart C Electronic Signatures 21 CFR Part 50 Protection of Human Subjects 21 CFR Part 50 Subpart B Informed Consent of Human Subjects 21 CFR Part 50 Subpart D Additional Safeguards for Children in Clinical Investigations 21 CFR Part 56 Institutional Review Board 21 CFR Part 56 Subpart B Organization and Personnel ...

RAC Practice Exam 1 Questions and Answers New Version 2023 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 reco...

Which of the following is NOT considered a significant factor in determining the outcome of an electrocution event? - Answer- 1. The amount of electrically resistant material present in work boots and work gloves. A Noise-Hazard Control Program (and associated Hearing Conservation Program) is required under OSHA regulation 29 CFR 1910.95 (Occupational Noise Exposure) where workers may be exposed to noise levels in excess of an eight -hour-time-weighted average of.. - Answer- 2. 85 decibels (d...

If angle A is 63.4 deg, What is the length of side C? Tangent side of angle A is 5, and adjacent side is 10. - Answer- Sin A = a/c, Sin 63.4=10/c, c=10/sin 63.4=11.2 What is the angle of the ramp that rises 4 feet in a 10 feet run? - Answer- Tan A = a/b, Tan A = 4/10, A = Arc Tan [4/10], A = 21.801 Based on the allowable limits in the table below if the noise in a work area was 95 dBA for 3 hours, 90 dBA for 5 hours and 85 dBA for 2 hours, is the allowable limited exceeded? - Answer- C = T...

SOCRA - CCRP (high level) questions and answers Nuremberg Code (1947) A research ethics code that arose in response to the Nazis' inhumane experimentation (nuremberg trials) - holocaust, racial hygiene / eugenics / master race. The Nuremberg Code - 10 points 1. voluntary 2. necessary for results 3. logical design and results 4. avoid unnecessary harm 5. cannot result in death or disablement 6. risk assessment 7. protect subjects against harm 8. qualified investigators 9. right...

CHST Test Questions with accurate answers. Latest update, graded A Which of the following is NOT considered a significant factor in determining the outcome of an electrocution event? - -1. The amount of electrically resistant material present in work boots and work gloves. A Noise-Hazard Control Program (and associated Hearing Conservation Program) is required under OSHA regulation 29 CFR 1910.95 (Occupational Noise Exposure) where workers may be exposed to noise levels in excess of an e...

Consent with Subjects Who Do Not Speak English Quiz Results You correctly answered 3 of 5 quiz questions. Question 1 Question A subject who does not speak English in the U.S. may indicate ot her areas that must be considered and addressed by researchers. Which of the following is most typically an associated concern? Your Answer Cultural differences Result Correct Comment Not speaking English in the U.S. typically indicates cultural differences (such as, deference to authority), which must be co...

CHST Test Questions and answers. 100% Accurate, graded A Which of the following is NOT considered a significant factor in determining the outcome of an electrocution event? - -1. The amount of electrically resistant material present in work boots and work gloves. A Noise-Hazard Control Program (and associated Hearing Conservation Program) is required under OSHA regulation 29 CFR 1910.95 (Occupational Noise Exposure) where workers may be exposed to noise levels in excess of an eight -hour...

CADC IL CADC Test Latest Exam Guide Completed CADC IL CADC Test Latest Exam Guide Completed 1. A wife refers her husband for substance abuse counseling. His drug of choice is cocaine, which he has been using episodically with friends at a poker game—biweekly to weekly—for some years. She is disturbed at the illicit nature of the drug and the long-standing use. He states that though he recreationally uses, he doesn't crave cocaine, doesn't seek it out but rather uses with friends at the ...