A trial site is specific location where clinical trial activities, including enrollment, treatment, and monitoring, are conducted. The trial site is characterized by the consistent application of the protocol and the involvement of a dedicated clinical team.
Definitions
ICH E6(R2)
- 1.59 Trial Site:
- The location(s) where trial-related activities are actually conducted [1].
Organization of a trial site
A trial site typically includes a team of principal investigators, sub-investigators, study coordinators, nurses, and other support staff. The site is equipped with the necessary facilities and personnel to carry out the clinical study according to the protocol.
Site selection
Within a large institution, different departments can operate their own trial sites, each focusing on its area of expertise while being part of the larger institutional framework. Depending on the protocol requirements, a site located in any department of a hospital may or may not be suitable for a specific trial. To evaluate suitability, a study feasibility assessment is conducted, followed by a site selection visit.
Trial site vs. institution
While a trial site is the location where the clinical trial is physically carried out, an institution is the broader entity that provides the infrastructure, oversight, and governance necessary for conducting clinical research. An institution can be a university, hospital system, research institute, or any organization with the authority and infrastructure to support trial sites.
| Trial site | Institution | |
|---|---|---|
| Definition and scope | A trial site is a specific physical location where the trial is conducted. | An institution is a larger organization that provides overarching governance and may encompass multiple trial sites. |
| Function | A trial site focuses on the operational execution of a trial. | An institution provides regulatory oversight, ethical review, and administrative support. |
| Staff and roles | A trial site is staffed by clinical research teams directly involved in subject interaction and data collection. | Institution staff includes administrative, legal, and compliance personnel who support and oversee the conduct of trials. |
Multiple sites within single institution
In clinical research, it is common for multiple trial sites to be operated within a single institution. This setup optimizes resources and streamlines the research process. Central management ensures compliance with regulatory standards and coordinates the overall administration of multiple trials.
Institutions can share facilities and equipment across different trial sites, including laboratories, imaging equipment, and patient care areas. A central institutional review board (IRB) or ethics committee can oversee the ethical aspects of all trials conducted within the institution, ensuring uniform standards and efficient review processes.
See also
Another relevant pages
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References
- ↑ ICH, 2016, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf Accessed Sep 2023
External links