Requirements for a sponsor under the EU CT Directive

Requirements for a sponsor under the EU CT Directive

For every trial that falls within the remit of Directive 2001/20/EC, a person or organisation must take on the responsibility of sponsor.

The Sponsor may make arrangements to delegate any or all of their trial-related functions to an individual, company, institution or organisation. However, in all such cases, the sponsor shall retain overall responsibility for ensuring that the conduct of the trials and the final data generated by those trials comply with Directive 2001/20/EC and Directive 2005/28/EC.

Definitions

“Sponsor” means, in relation to a clinical trial, the person who takes on responsibility for the initiation and management (or for arranging the initiation and management) of and the financing (or arranging the financing) for that clinical trial.

“investigator-sponsor” means, in relation to a clinical trial, a chief investigator who is also acting as the sponsor for that clinical trial.

investigational medicinal product means a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including a medicinal product that is already the subject of a marketing authorisation, but –

  • is used, formulated or packaged in a different way from the form that is the subject of the authorisation, or
  • is used for an indication that is not included in the summary of product characteristics under the authorisation for the product, or
  • is used to gain further information about the form of the product that is the subject of the authorisation

“Non-commercial clinical trials” are clinical trials conducted by researchers without the participation of the pharmaceutical industry. For that reason the following criteria may be followed to define non-commercial clinical trials:

Characteristics of the sponsor:

  • The sponsor should be a university, a hospital, a public scientific organisation, a non profit institution, a patient organisation or a researcher;
  • The ownership of the data of these trials should belong to the sponsor listed in the first bullet point;
  • No agreements between the sponsor and third parties allowing them to use the data for regulatory or marketing purposes should be in place
  • The design, conduct, recording and reporting of the clinical trial should be under the control of the sponsor.