Glossary Term
Study Sponsor
Definition
A study sponsor is an individual, institution, or organization responsible for initiating, managing, and funding a clinical trial or research study. The sponsor ensures that the study complies with ethical standards, regulatory requirements, and scientific integrity throughout its design, conduct, and reporting. Sponsors are also responsible for providing the necessary resources, such as funding, medical devices, drugs, or equipment, and for overseeing the recruitment of study sites and participants. The sponsor plays a central role in the execution and oversight of the study to ensure that the trial produces reliable and valid results.
Relevance to the MedTech Industry
Study sponsors facilitate and support the design, execution, and completion of a clinical trial. Sponsors ensure that the study adheres to ethical standards, scientific objectives, and regulatory guidelines while providing the necessary resources and funding. By overseeing the entire process, sponsors play a critical role in advancing medical research and ensuring patient safety.
Additional Information & Related Terms
Related Terms
Clinical Trial: A research study that tests the safety and effectiveness of a medical device, drug, or treatment, often sponsored by an organization or institution.
Principal Investigator (PI): The lead researcher at a study site responsible for overseeing the clinical trial, ensuring protocol compliance, and managing participant safety.
Study Protocol: A detailed plan that defines the methodology, objectives, and procedures for conducting a clinical trial, created by the sponsor.
Regulatory Submission: The process of submitting clinical trial data to regulatory agencies (e.g., FDA, EMA) for approval of a medical device or drug.
Ethics Committee (IRB): A group responsible for reviewing and approving clinical trials to ensure they meet ethical and regulatory standards, protecting patient safety.