Socra certification - Study guides, Class notes & Summaries

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...

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) - ...

QUESTIONS AND ANSWERS

SOCRA CERTIFICATION EXAM 2024 ACTUAL EXAM COMPLETE 200 QUESTIONS WITH DETAILED VERIFIED ANSWERS (100% CORRECT ANSWERS) / ALREADY GRADED A+

SOCRA CERTIFICATION EXAM 2024 WITH 100% CORRECT ANSWERS 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 f...

SoCRA Certification Exam Latest Update Graded A 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) Digital Signature An el...

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...

Test for SOCRA CCRP EXAM (Mega certification 2024) Q&A 5 - CORRECT ANSWER-The minimum number of IRB members Subjects cannot be enrolled until IRB/IEC approval has been obtained - CORRECT ANSWER-In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval? The Sponsor - CORRECT ANSWER-The responsibility for ensuring that the investigator understands a clinical trial lies with: A subject has been enrolled...

SOCRA CCRP Certification fully solved & updated (100- accuracy)