Glossary Term
Study Site
Definition
A study site refers to a specific location, such as a hospital, clinic, or research facility, where clinical trials or medical studies are conducted. It is the place where participants are enrolled, treatments or interventions are administered, and data are collected during the course of the study. Study sites are essential components of clinical trials and often involve multiple sites to gather diverse data, expand the participant pool, and ensure the validity and generalizability of study results.
Relevance to the MedTech Industry
A study site provides a controlled environment where clinical research can be conducted under ethical standards and regulatory compliance. Study sites are where medical professionals, researchers, and trial coordinators interact with participants, collect data, and ensure the proper implementation of the study protocol. They are essential for gathering real-world evidence and testing the safety and efficacy of medical devices, treatments, or interventions.
Additional Information & Related Terms
Related Terms
Clinical Trial: A research study that tests the safety and effectiveness of a medical device or treatment, often involving multiple study sites.
Principal Investigator (PI): The lead researcher at a study site who is responsible for overseeing the clinical trial and ensuring it adheres to the protocol.
Study Protocol: A detailed plan that defines the objectives, design, methodology, and procedures for a clinical trial, followed at each study site.
Institutional Review Board (IRB): A group responsible for reviewing the ethical aspects of a clinical trial and ensuring that patient safety and rights are protected.
Recruitment Strategy: The methods and processes used to enroll patients in a clinical trial, crucial for the success of study sites in meeting enrollment targets.