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

21 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 21 CFR Part 56 Subp...

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 ...

21 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 21 CFR Part 56 Subpart C IRB Functions and Operati...

CCRP SoCRA Exam Cert Exam Questions with Verified Answers 2024 21 CFR Part 11 - CORRECT ANSWER-Electronic Records; Electronic Signatures 21 CFR Part 11 Subpart B - CORRECT ANSWER-Electronic Records 21 CFR Part 11 Subpart C - CORRECT ANSWER-Electronic Signatures 21 CFR Part 50 - CORRECT ANSWER-Protection of Human Subjects 21 CFR Part 50 Subpart B - CORRECT ANSWER-Informed Consent of Human Subjects 21 CFR Part 50 Subpart D - CORRECT ANSWER-Additional Safeguards for Children in Clinical ...

CFR Title 21: Part 11 - Electronic Records; Electronic Signatures Part 11, Subpart A: General Provisions - -must be trustworthy, reliable, and generally equivalent to paper records -applies to electronic forms that are created, modified, maintained, archived, retrieved, or transmitted -where records meet requirements, it will be considered equivalent to full handwritten signatures, initials, etc. -must be available and subject to FDA inspection -may be in lieu of paper records or tr...

US RAC Review Questions RAPS Modules With Complete Solutions Latest Update 2023/2024 (Verified Answers). In which situation is an IND not required? A) You intend to conduct a clinical trial with an investigational new drug B) You intend to conduct a clinical trial with an approved drug to support a marketing application for a new indication C) You intend to collect blood samples from subjects to look for biomarkers or pharmacogenetic information D) You intend to conduct a clinical trial us...

CCRP SoCRA Exam Cert Exam Questions with Verified Answers 2024 21 CFR Part 11 - CORRECT ANSWER-Electronic Records; Electronic Signatures 21 CFR Part 11 Subpart B - CORRECT ANSWER-Electronic Records 21 CFR Part 11 Subpart C - CORRECT ANSWER-Electronic Signatures 21 CFR Part 50 - CORRECT ANSWER-Protection of Human Subjects 21 CFR Part 50 Subpart B - CORRECT ANSWER-Informed Consent of Human Subjects 21 CFR Part 50 Subpart D - CORRECT ANSWER-Additional Safeguards for Children in Clinical ...

1. During the applicant interview the primary purpose is to encourage the applicant to as much information as possible about themselves except: - Political & Religious beliefs are not subjects that should be discussed with a potential employee 2. A family is taking care of their Grandpa who has Alzheimer's disease. The family wants to take a short vacation so they contact the LTC facility for a short term stay called: - Respite Care 3. An Advanced Directive is? - Written instructions from...

45 CFR 46 Subpart A "Basic HHS Policy for Protection of Human Research Subjects": (46.100) Requirements for 1) assuring compliance by research institutions, 2) researchers' obtaining and documenting informed consent, 3) Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping. 45 CFR 46 Subpart B Additional protections for pregnant women, human fetuses, and neonates (46.200) 45 CFR 46 Subpart C Additional protection for prison...

21 CFR Part 11 - Answer- Electronic Records; Electronic Signatures 21 CFR Part 11 Subpart B - Answer- Electronic Records 21 CFR Part 11 Subpart C - Answer- Electronic Signatures 21 CFR Part 50 - Answer- Protection of Human Subjects 21 CFR Part 50 Subpart B - Answer- Informed Consent of Human Subjects 21 CFR Part 50 Subpart D - Answer- Additional Safeguards for Children in Clinical Investigations 21 CFR Part 56 - Answer- Institutional Review Board 21 CFR Part 56 Subpart B - A...