Clinical trials must be conducted in accordance with regulations to protect the rights, safety and welfare of research subjects as well as ensure the integrity of the data and study results.
 
Clinical trials are conducted under federal regulations. In Canada these regulations are governed by a  branch of the federal government called “Health Canada ”. In the USA the organization responsible is the Food and Drug Administration or FDA. In both countries the regulations describe how clinical research must be conducted and defined the responsibilities of doctors who conduct research (also called “Investigators”), the pharmaceutical companies that  develop the investigational products and sponsor the studies, as well as the ethical review boards that review the study protocols and informed consent forms to ensure that they are complete and des clinicals trials

There are many different people with different roles who work together in a clinical trial. Some of these include:
 
Research subjects - patients with medical conditions or volunteers who consent to participate in research protocols.

Investigators - Doctors, including medical specialists like Dr. Pommerville, who are responsible for the medical care and assessment of subjects and the overall conduct of the study at their site.

Research coordinators - Professionals who work with the investigators to ensure that all of the details required by the protocols are correctly implemented. Research coordinators spend a lot of time with study subjects during the study.

Sponsors - Pharmaceutical or biotechnology companies who are developing new investigational therapies and want to conduct  studies to assess the safety and effectiveness of their products. 

Monitors - Employees or representatives of the Sponsors who visit a site during a study to ensure that the study is being conducted in accordance with the protocol and applicable regulations.

Ethics Committees - Also known as Institutional Review Boards or Research Ethics Boards, these are independent committees of medical and other professionals and lay people who review  and monitor research projects to ensure that the rights safety and welfare of research subjects are protected and that the research itself is scientifically and clinically solid.

Laboratories - Perform the tests needed to assess the impact of the investigational product being tested on a person’s physiological parameters.

Hospitals and Other  Diagnostic Facilities - Provide valuable services to monitor the status and progress of the conditions under study, including CT scans, x-rays, biopsies, bone scans and many other specialized diagnostic tests.