Ccrp exam practice test - Study guides, Class notes & Summaries

MEGA SOCRA CCRP EXAM CONTENT REVIEW PRACTICE TEST. 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 ...

SOCRA CCRP Exam Practice 100% Solved 21 CFR part 11 regulates? - ANSElectronic Signatures What is the name of FDA Form 483? - ANSInspectional Observation What does 21CFR56 regulate? - ANSInstitutional Review Boards An application for Investigational Device Exemption is part of 21 CFR part ____________? - ANS812 Define Electronic Signature - ANSA computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be legally binding equivalent ...

CCRP Final Exam Study Guide Practice Questions. Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the: - correct answer PI and Sponsor. In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? - correct answer The subject's legally acceptable representative Which of the following required elements should be included in a clinical trial protocol? - correct answer The subject inclusion and e...

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