This is the person or organisation who initiates the clinical trial. Sponsors can include doctors, medical institutions, hospitals, government agencies, and pharmaceutical companies, among others.
The clinic or institution where a clinical trial takes place is often referred to as the “site”. In many cases, a sponsor will have a multi-centre study, which means that the sponsor has partnered with many sites in various geographic regions to all conduct the same clinical trial.
The Principal Investigator
The principal investigator (“PI”) is the person responsible for all aspects of the study at the research site. The PI is usually a medical doctor. One of the primary responsibilities of the PI is to create and oversee a research study team of healthcare professionals, including other doctors, who help to perform the research at the site. Each study team member must be qualified by education, training, and experience for his or her designated role on the study team.
The Study Coordinator
Research assistants for clinical trials are called study coordinators or clinical research coordinators. A study coordinator’s job is to support the investigator, including corresponding with Ethics Review Board (ERB), identifying eligible patients, participating in the Informed Consent process, scheduling study visits, and maintaining study files.
Also referred to as the patient, volunteer, or study subject, the participant is the person that has agreed to take part in a clinical trial.
The Ethics Review Board
A group of people with varying backgrounds that relies on their experience and expertise to ensure that rights and welfare of participants are protected.