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...

SOCRA CCRP Practice Test with complete Solutions | Latest 2023/2024 Which of the following is a disclosure of financial interests form? ️ FDA Form 3455 Which of the following is a certification of financial interest form? ️ FDA Form 3454 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: ️ FDA Form 3455 This form is submitted by sponsor to the FDA prior to the beginning of the drug trial ️ Investigational New Drug Applicat...

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 Guide Test. ADME - correct answer absorption, distribution, metabolism, excretion BA - correct answer bioavailability BE - correct answer bioequivalence CTA - correct answer clinical trial authority CTI - correct answer clinical trial investigator DMC - correct answer Data Monitoring Committee GLP - correct answer Good Laboratory Practices GMP - correct answer Good Manufacturing Practices PSUR - correct answer Periodic Safety Update Report IEC - correc...

Socra CCRP test questions and answers

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 ...

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...