The EU directive defines a sponsor as an individual, company, institution or organisation which takes responsibility for the initiation, management and/or financing of a clinical trial. The FDA also describes the sponsor in somewhat similar manner but also adds that “a Sponsor-Investigator is an individual who both initiates and conducts a clinical investigation and under whose immediate direction the investigational drug is being administered or dispensed”.

If the trial involves a new medicinal product then one clear method of identifying the sponsor is by working out who is responsible for submitting the Investigational Drug Application (IND) or Clinical Trial Application (CTA) to the regulatory authority in regions and countries where this is a requirement.
The “funder” of the trial is not necessarily the sponsor; the sponsor takes responsibility for the management and monitoring of the trial as well (even if they outsource this task). The table below depicts typical sponsors and the conditions for sponsorship:

Sponsor’s Responsibilities
The roles and responsibilities of sponsors in clinical trials is clearly stated in the ICH GCP guidelines and all sponsors will need to follow these guidelines for their trial to receive authorisation. Some of the broader roles of a sponsor include but are not limited to the following:

- Select Investigators
- Monitor progress of clinical trial
- Ensure trial is conducted in accordance with protocol
- Monitor safety
- Drug disposition and reconciliation
- Maintain required records and reports

A sponsor can transfer any or all of its trial-related duties to a contract research organization (CRO), but will still have ultimate responsibility for the quality and integrity of trial data. In many cases, the role of the sponsor is often identified very early and it is in cases where there are a number of collaborators with key involvement in study planning and/or funding that the role could be seemingly vague.

One of the key responsibilities of the sponsor is the provision of clinical trial indemnity insurance. Many, but not all, trials will require insurance and it is the sponsor’s requirement to assess the need and ensure that the appropriate policy is in place. This would also encompass ensuring that adequate professional liability cover is held by the clinicians involved. Again this is not always required or indeed standard practice in many countries. It is the sponsor’s role to work with the investigators and trial sites to assess the risk and complexity of the trial and to assess this with the local practice for covering professional liability (often the institution or ministry of health cover the costs of claims and legal fees and this is written into clinician’s contracts).

References
Clinical Research Governance Office, Imperial college London “what is a Sponsor” http://www3.imperial.ac.uk/clinicalresearchgovernanceoffice/projectplanning/isasponsorneede