Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (Text with EEA relevance) (c. 28)

CHAPTER 2 GOOD CLINICAL PRACTICE FOR THE DESIGN, CONDUCT, RECORDING AND REPORTING OF CLINICAL TRIALS

SECTION 3 THE SPONSORS

Article 7

1. A sponsor may delegate any or all of his trial-related functions to an individual, a company, an institution or an organisation.

However, in such cases, the sponsor shall remain responsible for ensuring that the conduct of the trials and the final data generated by those trials comply with Directive 2001/20/EC as well as this Directive.

2. The investigator and the sponsor may be the same person.