A clinical study sponsor refers to an individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study or trial. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor- investigator.

Sponsor is an individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial. Sponsor-Investigator is an individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is ...

Sponsor role and oversight responsibilities in global clinical trials, including those trials incorporating novel designs, operational approaches, and data sources (RWD/RWE)

2012年10月17日 · In the conduct of a clinical trial, a sponsor is an individual, institution, company or organization (for example, a contract research organization) that takes the responsibility to initiate, manage or finance the clinical trial, 1 but does not actually conduct the investigation.

“A Sponsor means a person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization or other organization. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator.”

2021年5月26日 · The sponsor is responsible for ensuring that a clinical trial complies with the legislation and GCP. If a sponsor of a CTIMP is a commercial or other non-NHS body, a copy of an insurance or indemnity certificate should normally be included with the REC application as evidence of the cover in place for the potential liability of the sponsor.

2020年3月19日 · Sponsor: An individual or entity who takes responsibility for and initiates a clinical investigation. Clinical Investigator: An individual who conducts a clinical investigation under whose immediate supervision the investigational drug/device is administered. Ther. In. Reg. Sci. 2016. 50(4) 436-441. to “completely” avoidable. Getz, K.A., et. al.

This guidance is intended to assist clinical trial sponsors in determining when a DMC may be useful for study monitoring, and how such committees should operate. We

Definition of Sponsor…. • “An individual, company, institution or organization which takes responsibility for the initiation, management, and / or financing of a clinical trial.” (ICH) • “A person who takes responsibility for and initiates a clinical investigation. …

2016年6月24日 · A variety of organizations may sponsor a clinical trial. According to the U.S. National Library of Medicine, clinical trial sponsors may include: Government agencies; such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran’s Affairs (VA) Private individuals, companies or organizations