Socra certification exam Study guides, Class notes & Summaries

SoCRA CERTIFICATION EXAM AND PRACTICE EXAM 2023-2024 ACTUAL EXAMS 400 QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES (VERIFIED ANSWERS) | ALREADY GRADED A+

CCRP SoCRA Exam Latest Update Rated A 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 Subpa...

Does the FDA consider electronic signatures to be as trustworthy and reliable as handwritten paper signatures? - Answer - Yes (although permission to use such e-sigs has to be approved by the FDA) Does the FDA consider electronic records that meet requirements to be equivalent to handwritten records ? - Answer - Yes Open system (FDA term) - Answer - System access is NOT controlled by people who are responsible for the content of the electronic records in the system. (Like me putting data i...

QUESTIONS AND ANSWERS

Biometrics - ANSWER A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable. (21 CFR, Sec. 11.3) Closed System - ANSWER An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec. 11.3) Digital Signature - ANSWER An electronic signatur...

SoCRA Certification Exam 2023 with complete answers Biometrics A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable. (21 CFR, Sec. 11.3) Closed System An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec. 11.3) Digi...

SoCRA Certification Exam 2024 A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable. (21 CFR, Sec. 11.3) - ANSWER Biometrics An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec. 11.3) - ...

SOCRA CERTIFICATION EXAM 2024 Does the FDA consider electronic signatures to be as trustworthy and reliable as handwritten paper signatures? - correct answer Yes (although permission to use such e-sigs has to be approved by the FDA) Does the FDA consider electronic records that meet requirements to be equivalent to handwritten records ? - correct answer Yes Open system (FDA term) - correct answer System access is NOT controlled by people who are responsible for the content of the elec...