Clarification of EU Directive on Clinical Trials

The definition and responsibilities of sponsor are given in Article 2 of Directive 2001/20/EC

(e) ‘sponsor’: an individual, company, institution or organization which takes responsibility for the initiation, management and/or financing of a clinical trial;

How should this definition be interpreted?


As defined in the Directive the sponsor can be an individual, a company, an institution or an organisation. The sponsor does not need to be located in an EU Member State but has to have a legal representative in the EU. The investigator and the sponsor may be the same person.

The sponsor may delegate any or all of his trial-related tasks/duties and functions to an individual, company, institution or organisation. In cases where there are tasks and functions delegated to other persons/parties, there must be still an overall sponsor for the trial. Any trial-related duties and functions that are delegated to a third party should be specified in writing.

The sponsor might delegate his tasks and duties e.g.

– for compiling the documents for the application to the Ethics Committee and/or Competent Authorities including obtaining details of the manufacturing and import authorisation;

– for the monitoring of the trial including all responsibilities for the pharmaco- vigilance reporting system according to Articles 16 and 17 of Directive 2001/20/EC. However, in such cases the sponsor remains ultimately responsible for ensuring that the conduct of the trials and the final data generated by those trials comply with the requirements of Directive 2001/20/EC as well as of Directive 2001/83/EC in the case of a marketing authorisation application.

Allocation of trial-related responsibilities

Prior to initiating a trial, the sponsor should define, establish and allocate all trial- related duties and functions.

A number of parties may agree, in writing, to form an organisation according to Article 2 of Directive 2001/20/EC and to distribute the sponsors tasks/duties and functions between different ‘person(s) and/or ‘organisation(s)’. This is done in such a way that the collective agreement fulfils all the required roles and responsibilities of the sponsor.

The organisation will be identified by its name and by the EudraCT number (YYYYNNNNNN-CC and a group name) for the purpose of the trial and on the related documents.

Implications on non-commercial clinical trials support received

Support from industry by providing medicinal products free or at reduced costs or by providing financial or material or scientific support should not be taken to imply that industry is participating in the trials for the purpose of the Commission Directive on Good Clinical Practice and should not disqualify the trial from being regarded as a non-commercial trial.

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