The Sponsor is an individual or organization who initiates a trial and is responsible for its management, finance and results.Often this is the pharmaceutical company developing the test medication. The Sponsor may delegate day to day running of a trial to a service company (eg. CRO) or institution specializing in clinical research.An independent research entity may also become a Sponsor in the case of unpatented products. An Investigator conducting a trial on his own initiative and working independently assumes the role of Sponsor as well.

Sponsor's Main Responsibilities:

• establishing SOPs to comply with GCP

• selecting appropriately qualified Investigator(s)

• providing investigative staff with information on trial materials (Investigator's Brochure)

• manufacturing trial materials to GMP standards

• providing a scientifically robust, ethically transparent, signed protocol

• providing trial recording documents

• obtaining appropriate regulatory approvals

• establishing compensation and insurance procedures

• ensuring proper monitoring of the trial

• ensuring adherence to the protocol

• keeping drug records

• ensuring that new AE data and relevant information, is supplied to the relevant persons

• taking appropriate actions on Serious Adverse Events

• making provision for handling and analyses of trial data

• agreeing a publications policy

• ensuring the preparation and publication of a final trial report

• accounting for recovering and unused trial materials.
  

Back to Stakeholder model