21 cfr part 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...

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 ...

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...

SOCRA CCRP Exam Questions & Answers 2023/2024 April 30 1996 - ANSWER-ICH GCP Development Date Quality - ANSWER-ICH Q Efficacy - ANSWER-ICH E Safety - ANSWER-ICH S Multidisciplinary - ANSWER-ICH M guidance for industry, consolidated guideance - ANSWER-ICH E 6 Clinical Safety Data Management Definitions and Standards - ANSWER-ICH E2A Safety pharmacology studies for human pharmaceuticals - ANSWER-ICH S7A Electronic records, electronic signatures - ANSWER-21 CFR Part 11 ...

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...

Nuremberg Code (1947) Correct Answer 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 Correct Answer 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...

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 Questions and Answers 100% Solved | Latest Update April 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 Financial Disclosures - 21...

Module 4: Good Clinical Practice: FDA Regulations, FDA Guidance, and ICHThe Code of Federal Regulations (CFR) - correct answer Codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government, including the FDA. Divided into 50 titles and these are assigned to federal regulatory topics and/or government departments and agencies TITLE 21 FDA Part 200-499 - correct answer Drugs Title 21 FDA Part 600-699 - co...

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 ...