Glossary of Clinical Terms

✅ In the context of clinical trials, a “sponsor” is an individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial. The sponsor is typically the party that submits the clinical trial application to regulatory authorities and is ultimately responsible for ensuring that the trial is conducted in compliance with ethical and regulatory guidelines.

✅ The sponsor may be a pharmaceutical or biotechnology company developing a new drug or a vaccine or a medical device. A sponsor could also be a government agency sponsoring a trial to evaluate a public health intervention, or an academic institution conducting research on a new treatment or diagnostic test. The sponsor is responsible for all aspects of the clinical trial, including the design and conduct of the study, recruitment, and enrollment of participants, management of study data, and reporting of study results. The sponsor is also responsible for trial conduct with the highest ethical norms and maintaining the integrity and credibility of the data.

✅ The sponsor is bound by all the applicable regulatory norms and legal requirements. The sponsor is responsible for providing funding for the trial or for arranging funding from other sources. In addition to their responsibilities during the conduct of the trial, sponsors may also be responsible for post-trial activities such as the reporting of adverse events and long-term follow-up of study participants. Sponsors need to provide regular updates to regulatory authorities regarding the progress and outcomes of the clinical trial to the designated authorities.