Sponsors, investigators and other key study roles
Successfully conducting a trial requires close collaboration with and support from organisations and individuals.
The ‘Sponsor’ is the entity which takes overall legal responsibility for the initiation and conduct of a trial. The Sponsor is not necessarily the Funder.
Regulatory responsibility for delivering a trial rests with the Sponsor. Examples of a Sponsor include hospitals or healthcare organisations, academic institutions such as Universities or Institutes, or Pharmaceutical Companies. Sponsors may delegate some regulatory and oversight responsibilities to the Chief Investigator.
The chief investigator is usually appointed by the Sponsor and has overall responsibility for all aspects of trial oversight, management and day to day running of the trial. The chief investigator is often, but not always, an employee of the Sponsor.
The chief investigator must be in a position to supervise the research effectively, and must be readily accessible to the ethics committee and other regulatory bodies.
In some countries the Chief Investigator is called the Principal Investigator.
The principal investigator is responsible for the conduct of research at an individual research site. For multi-centre trials, there would typically be many principal investigators under one chief investigator. There should be one principal investigator for each site. The chief investigator may also serve as principal investigator at their own research site.
In some countries the Principal Investigator is referred to as the Site Investigator or Co-investigator.
Trial Managers or Coordinators have the responsibility of the day to day coordination and management of their allocated studies and trials. This involves working with the investigators to develop all study documents, arrange submissions, manage the Trial Master File (TMF) and any study/trial administration and coordination requirements. The Trial Manager or Coordinator also works closely with research sites to facilitate set-up and to ensure smooth running of the trial.
Many trials are supported by a Clinical Trials Unit or Centre (CTU/CTC). CTUs or CTCs are specialist units or institutions that usually support all aspects of clinical trials, including oversight, monitoring, statistics, data hosting and data management, pharmacovigilance and reporting. Many sponsors consider support by an accredited CTU or CTC a condition to sponsorship.
Many trial funders or sponsors will recommend the formation of a steering committee, especially for larger trials. The Chief Investigator reports to the steering committee regularly on the trial progress. The role of the committee is to advise on or authorize important changes to trial conduct (including any changes to the protocol). Typically it will include senior investigators in the trial and independent experts.
Also known as Data Monitoring Board (DMB) or Data and Safety Monitoring Committee (DSMC), many funders and sponsors will recommend the formation of a committee to review adverse events and trial progress. The members should be independent of the study team and are tasked with advising of changes to protocol or even cessation of the study in the event of an unacceptable excess of adverse outcomes or futility. Not all studies require a DSMB and the WHO has published guidelines for their establishment.