Who contributes to running of Clinical Trial

FDA: 

    United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

IRB: 

    Under FDA regulations, an Institutional Review Board is a group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. It is an independent committee that consists of physicians, dentists, statisticians, and members of the community. Also called as Ethics Committee.

Sponsor: 

    Company or institution/organization which takes responsibility for initiation, management and financing of clinical trial.

Project Monitor: 

    Also called as Clinical Research Associate, appointed by Sponsor to review the clinical study data.

Investigator: 

    Responsible for conduct of clinical trial at the trial site. Also called as Principal Investigator. Can also be referred as Team leader.

Site Staff: 

    Site Staff are those who work at sites. Few of them are Sub Investigator, Clinical Research Coordinator, Nurse, Lab Report Receiver, IRB Contact, Radiologist etc.,

Patients: 

    Human subjects participating in Clinical Trials.

Next: FDA Drug Approval Process