Clinical Research: Role and Responsibilities Questions with correct answers
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Course
Clinical research coordinator certification
Institution
Clinical Research Coordinator Certification
Who is the regulatory authority in the USA? Correct Answer-FDA
What are the goals of regulatory authorities? Correct Answer-Protect the public, gather clean data, ensure products are safe and efficacious
What are FDA program centers? Correct Answer-CDER, CBER and CDRH
What does CDER stand ...
Clinical Research: Role and Responsibilities Questions
with correct answers
Who is the regulatory authority in the USA? Correct Answer-FDA
What are the goals of regulatory authorities? Correct Answer-Protect the
public, gather clean data, ensure products are safe and efficacious
What are FDA program centers? Correct Answer-CDER, CBER and
CDRH
What does CDER stand for? Correct Answer-Center for Drug
Evaluation and Research
What does CBER stand for? Correct Answer-Center for Biologics
Evaluation and Research
What does CDRH stand for? Correct Answer-Center for Devices and
Radiologic Health
What is a sponsor? Correct Answer-company/person initiating a clinical
trial
What are the sponsor representative? Correct Answer-Clinical
Personnel, Data Management, Regulatory Affairs
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