45 cfr 46 subpart b - Study guides, Class notes & Summaries

CCRP Exam Questions answered 100% correct How many days does a sponsor have to report an emergency use of an IP to the FDA? 5 working days How many members must sit on an IRB? 5 How long must an IRB retain records per 21 CFR 56? 3 years after completion of research What are the criteria for IRB approval of research? (7) 1. Risks to subjects are minimized 2. Risks are reasonable in relation to anticipated benefits 3. Selection of subjects is equitable 4. Informed cons...

SOCRA Exam With 100% Correct Answers 2023

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...

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...

CITI Training: Biomedical Research Investigator & Social and Behavioral Research Questions and Answers 2023 What is included in the Nuremberg Code voluntary consent the National Research Act of 1974: established the National Commission Issued in 1974, 45 CFR 46 raised to regulatory status: US Public Health Service Policy What Belmont principle describes the application of informed consent respect of persons Result of Beecher article: ethical abuses are not limit...

CPH Exam Practice 93 Questions with Verified Answers The lengths of stay for six patients were 0, 0, 1, 2, 2, and 16 days. Which is (are) the best measure(s) to summarize these data? A) Mean B) Median C) Median and SD D) Mean and SD E) Median and Range - CORRECT ANSWER E) Median and Range An epidemiologist attempts to predict the weight of an elderly person from demispan. She randomly chooses 70 elderly subjects in a particular geographic area and records their weight and demispan...

CCRP Exam questions well answered latest 2023How many days does a sponsor have to report an emergency use of an IP to the FDA? 5 working days How many members must sit on an IRB? 5 How long must an IRB retain records per 21 CFR 56? 3 years after completion of research What are the criteria for IRB approval of research? (7) 1. Risks to subjects are minimized 2. Risks are reasonable in relation to anticipated benefits 3. Selection of subjects is equitable 4. Informed co...

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...

CPH Exam Study Guide 136 Questions with Verified Answers epidemiological triad - CORRECT ANSWER host, agent, environment An _______ is the probability that an event will occur divided by the probability that it will not occur. Since probabilities cannot be ______, a negative odds ratio would indicate computational ______. - CORRECT ANSWER odds ratio, negative, error _______ is the proportion of truly diseased people in the screened population who are identified as having the disease b...

Belmont Report (1979) - ANSWER ethical principles and guidelines for the protection of human subjects of research. respect for persons - ANSWER individuals should be treated as autonomous agents and persons with diminished autonomy are entitled to protection An autonomous person - ANSWER A person capable of deliberation about personal goals and of acting under the direction of such deliberation Beneficence - ANSWER Do not harm and maximize possible benefits and minimize possible harms ...