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+

Biometrics - CORRECT 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 - CORRECT 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 - CORRECT...

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 electronic records in the system. (...

SOCRA CCRP Exam Questions And Answers 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 ...

SOCRA Practice Test Exam Questions And Answers

SOCRA Certification Exam Questions And Answers

Socra Exam Prep Exam Questions And Answers

SoCRA Certification Exam QueBiometrics - 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...

Biometrics - CORRECT 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 - CORRECT 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 - CORRECT...

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 electronic records in the system. (...

SOCRA FDA timelines questions and answers A+ score assured 2024/2025