A clinical trial is initiated by a “Sponsor”, an organization/person who has authority and control over the study. Sponsors are generally the party who funds a study, although they might do this with the help of a “collaborator” (an organization in addition to the sponsor that provides support for a clinical study). Sponsors are required to create a study plan (or a “protocol”) that details how a trial will be conducted. The study protocol includes a study design, objectives, methods, and statistical considerations required for a trial, among other information. The Sponsor is responsible for ensuring the trial is conducted according to the study protocol and is responsible for seeking approvals to run the trial from regulatory agencies and ethics boards, as applicable.
The Sponsor generally must submit an application to run a clinical trial to its local regulatory agency. In the US, this means an Investigational New Drug (IND) application must be submitted to the Food and Drug Administration. Outside of the US this is often known as a “clinical trial application.” The regulatory authority is responsible for ensuring trials are designed to comply with applicable laws, regulations and good clinical practice principles. In addition to review by regulatory authorities, clinical trials must be reviewed and approved by an Ethics Committee or an “Institutional Review Board” (IRB). The ethics committee or IRB is responsible for the review of clinical trials in order to protect the rights and welfare of individuals in a clinical trial. One of the main responsibilities of the IRB is to review the informed consent form (ICF) to make sure it states:
An “Investigator” is responsible for conducting the trial at a particular study site once all approvals are in place in accordance with the protocol. The Investigator is also responsible for selecting patients for a trial per the specific criteria listed in the protocol. For a given clinical trial there can be one or many Investigators and multiple clinical research sites enrolling patients.