Institution

Institution – is a medical organization, facility, or entity that directly conducts or oversees clinical trials and research activities. These institutions include a wide range of entities, such as hospitals, academic medical centers, government agencies, facilities of pharmaceutical companies, contract research organizations (CROs), and other healthcare organizations.

Definitions

ICH E6(R2)

1.30 Institution (medical):

Any public or private entity or agency or medical or dental facility where clinical trials are conducted .

Organization

Institutions serves as the setting for research activities, providing the necessary infrastructure, facilities, expertise and personnel for the execution of clinical trials. They often have dedicated research departments, laboratories, and facilities for archiving data. Furthermore, institutions often collaborate with other organizations, such as sponsors, drug depot, regulatory authorities.

Generally, institutions have ethics committees to ensure that clinical trials are conducted ethically, in compliance with regulatory requirements, and with the highest standards of patient safety and data integrity.

Personnel

Typically, institutions include several investigational sites, each consisting of specialized personnel who are responsible for designing, implementing, and managing clinical trials. These personnel may include principal investigators, research coordinators, physicians, study nurses, and regulatory affairs professionals.

See also

Another relevant pages

• Investigator

Links to this page

• Independent ethics committee ‎ (← links)
• Investigator ‎ (← links)
• Source documents ‎ (← links)
• Standard operating procedures ‎ (← links)
• Sub-investigator ‎ (← links)
• Trial site ‎ (← links)