SOCRA EXAMS BUNDLE| Questions with 100% Correct 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...

Contract Research Organization - ANSWER A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. When a short form is used for informed consent the witness must sign the short form or the sum...

Which of the following is a disclosure of financial interests form? - ANSWER FDA Form 3455 Which of the following is a certification of financial interest form? - ANSWER FDA Form 3454 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - AN...

SOCRA EXAM 2024- with 100% Correct Answers ( A Graded) Electronic signature are currently accepted for any and all records, paper or electronic form. True or False? - ANSWER False. The general provisions for electeonic signature criteria apply to records that are i. Created, modified, maintaine...

Laws - ANSWER passed by national legislative bodies; establish authority of national regulatory body Regulations - ANSWER Passed by regulatory authorities; controls how medical products are investigated and approved; have effect of law guidance - ANSWER "current thinking" of regulatory bodies;...