What is 45 cfr part 46 - Study guides, Class notes & Summaries

Which of the following was the result of the Beecher article? - ANSWER-Realization that ethical abuses are not limited to the Nazi regime The use of prisoners in research is a concern under the *Belmont principle of Justice* because: - ANSWER-Prisoners may be used to conduct research that only benefits the larger society Issued in 1974, 45 CFR 46 raised to regulatory status: - ANSWER-US Public Health Service Policy (45 CFR 46 raised to regulatory status the US Public Health Service policy ...

CRA Exam Practice 93 Questions with Verified Answers Who uses eBRAP for proposal submissions - CORRECT ANSWER DOD SD-272- federal cash transaction report - CORRECT ANSWER 1 grant/cooperative agreement ASAP Automated Standard Application for Payments - CORRECT ANSWER a secure, web-based all electronic payment and information application that allows federal agencies to choose from three payment models to fit their financial needs and streamline operations at no charge to federal agencies...

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 CCRP Exam Question with complete solution 2023April 30 1996 ICH GCP Development Date Quality ICH Q Efficacy ICH E Safety ICH S Multidisciplinary ICH M guidance for industry, consolidated guideance ICH E 6 Clinical Safety Data Management Definitions and Standards ICH E2A Safety pharmacology studies for human pharmaceuticals ICH S7A Electronic records, electronic signatures 21 CFR Part 11 Informed Consent 21 CFR Part 50...

OTR 630 FINALS 100% CORRECT REVISED SOLUTIONS 2023//2024 A Quantitative approach ___________________ (a) follows an open, flexible and unstructured approach (b) emphasizes description, narration and feelings (c) believes in substantiation on the basis of a larger sample size (d) Communicates findings in a descriptive rather than analytical manner - ANSWER (c) believes in substantiation on the basis of a larger sample size What separates qualitative and quantitative research? (a) phil...

The ICH is concerned with harmonization of technical requirements for registration of pharmaceutical products from what three regions? - European Union, Japan and United States What organizations are represented in the ICH Steering Committee? - Australia, Canada, the Nordic countries and the World Health Organization (WHO), European Union, Japan, and the United States What ethical standards are the ICH Documents based on? - Declaration of Helsinki What is the status of ICH in U...

Practice Questions for SOCRA exam questions and answers already graded A+| Updated & Verified | 2024 Which of the following is a disclosure of financial interests form? - Which of the following is a certification of financial interest form? - If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - Investigational New Drug Application In the to...

OSHA 510 Exam Questions and Answers Already Passed 2024 A+ OSHA stands for: Occupational Safety and Health Administration 2. OSHA's focus four injuries are:: 1. fall 2. caught-in 3. struck by 4. electrical 3. OSHA's mission is to _____ and _____.: save lives and prevent injuries 4. OSHA's primary method of enforcement of safety regulations is through _____.: worksite inspections 5. OSHA was formed because _____ were increasing.: injuries and illnesses 6. OSHA was signed into law by ...

SOCRA Practice 1 questions and answers latest 2023 True or False The terms "treatment protocol" and "treatment IND" are interchangeable and mean the same thing. False. A treatment protocol is sponsored by a sponsor, while a treatment IND (Investigational New Drug) is sponsored by a licensed medical practitioner who becomes a sponsored investigator. 21 CRF 312.35 True or False Investigators are responsible for periodically requesting updates regarding new information gleaned by a ...

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...