Clinical Research: Role and Responsibilities questions with correct answers

Who is the regulatory authority in the USA? CORRECT ANS FDA What are the goals of regulatory authorities? CORRECT ANS Protect the public, gather clean data, ensure products are safe and efficacious What are FDA program centers? CORRECT ANS CDER, CBER and CDRH What does CDER stand for? CORRECT ANS Center for Drug Evaluation and Research What does CBER stand for? CORRECT ANS Center for Biologics Evaluation and Research What does CDRH stand for? CORRECT ANS Center for Devices and Radiologic Health What is a sponsor? CORRECT ANS company/person initiating a clinical trial What are the sponsor representative? CORRECT ANS Clinical Personnel, Data Management, Regulatory Affairs What is the role of the clinical research associate? CORRECT ANS Assure subject safety, monitor compliance with regulations, GCP, sponsor and site SOPs, ensure investigation product accountability, verify CRF data against source document, ensure complete and consistent regulatory documentation, serves as liaison between sponsor and site Define contract research organization. CORRECT ANS Person assumes as an