Ccrp socra test - Study guides, Class notes & Summaries

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...

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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 on a study and was randomized to the non-treatment arm. ...

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...

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 summary? - ANSWER False-they must sign both What is FDA form 3454 - ANSWER Certification Financial Interests and Arrangements of Clinical Investigators

SoCRA Common Terms and Key phrases in CCRP Certification Exam Study Guide Questions and Approved Answers 2023/2024 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 fo...

SOCRA CCRP Exam Practice Test Questions With Complete Solutions 21 CFR part 11 regulates? - ANSWER Electronic Signatures What is the name of FDA Form 483? - ANSWER Inspectional Observation What does 21CFR56 regulate? - ANSWER Institutional Review Boards An application for Investigational Device Exemption is part of 21 CFR part ____________? - ANSWER 812 Define Electronic Signature - ANSWER A computer data compilation of any symbol or series of symbols executed, ...