What is 21 cfr 11 - Study guides, Class notes & Summaries

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 Establishment of and adherence to written procedures - A. T...

SOCRA CCRP Exam Practice Questions and answers, VERIFIED/ 21 CFR part 11 regulates? - -Electronic Signatures What is the name of FDA Form 483? - -Inspectional Observation What does 21CFR56 regulate? - -Institutional Review Boards An application for Investigational Device Exemption is part of 21 CFR part ____________? - -812 Define Electronic Signature - -A computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be legally binding...

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 to withdrawal 10. right to end trial if needed ...

OSHA 30 CONSTRUCTION TEST ANSWER KEY INTRODUCTION TO OSHA – LATEST VERSION ALREADY PASSED The CFR Parts, such as Part 1926 for Construction, are further broken down into ___________, which group together specific and detailed standards. A. Bullets B. Pieces C. Slices D. Subparts D. Subparts (correct answer) Get OSHA 30 Exam Passed - 1. When the employer receives an OSHA citation, it must be: A. Contested and filed with the courts B. Copied and mailed to each worker C...

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 Establishment of and adherence to written procedures - A. T...

DOT QUESTIONS AND ANSWERS FULLY SOLVED 1. Which of the following is true? *The FMCSA does not consider feasibility or impact in the rule-making process. *Only the Medical Review Board can provide advice and opinions on FMCSA rulemaking. *FMCSA medical standards and guidelines are subject to public notice and comment rulemaking. *The Code of Federal Regulations provide guidance that the medical examiner may or may not follow. FMCSA medical standards and guidelines are subject to p...

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...

CHST Test| questions and answers/correct and verified A+CHST Test| questions and answers/correct and verified A+ Which of the following is NOT considered a significant factor in determining the outcome of an electrocution event? - correct answers-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) whe...

NRCME-Exam Questions and Answers 100% Verified What are regulations? - answerLaws that must be followed What are disqualifying medical conditions? - answerEpilepsy monocular vision hearing loss What are guidelines? - answerRecommendation to follow but can have raptor ale for variation FMCSA medical program responsibilities include: Oversee the Department of Transportation. Regulation of intrastate commercial motor vehicle operations. Conduct and oversee the agency's medical exemption...

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 Establishment of and adherence to written procedures - A. T...