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Clinical Research: Role and Responsibilities Questions with correct answers

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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 What is the role of the clinical research associate? Correct Answer-Assure subject safety, monitor compliance with regulations, GCP, sponsor and site SOPs, ensure investigatio

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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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