Socra exam 2022 Study guides, Class notes & Summaries

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 2022/2023 with Complete Solution

Practice Questions for SOCRA exam VERIFIED 2022/2023

SOCRA Certification Exam Q&A 2022/2023

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 Q&A 2022/2023

CCRP SOCRA EXAM VERIFIED 2022 QUESTIONS AND ANSWERS

Practice Questions for SOCRA exam VERIFIED 2022/2023Which of the following is a disclosure of financial interests form? ... Which of the following is a certification of financial interest form? ... 00:27 01:29 If the investigator did have financial arrangement with the spons...

EIR - ANSWER-Establishment Inspection Report 21 CFR Part 11 - ANSWER-Electronic records & electronic signatures 21 CFR Part 50 - ANSWER-Protection of human subjects; general requirements of ICF; ICF if patient is in coma, life threatening conditions 21 CFR Part 56 - ANSWER-IRB (Basic element of an IRB); (Memberships, role, etc) 21 CFR Part 312 - ANSWER-Investigational New Drug (IND) application (requirements of IND); Requirements of expanded access or emergency use; 1572 21 CFR Pa...

SOCRA Certification Exam 2022/2023 with Complete Solution