Working with the EU Clinical Trials Directive

Under the auspices of the EU Clinical Trials Directive 2001/20/EC investigator led studies are required to adhere to Good Clinical Practice guidelines for clinical trials of investigational medical products. This means that such studies are required to have a clinical trial sponsor for all studies.

For these clinical trials held in Europe the sponsor responsibilities cover a range of different activities. Sponsors are required to oversee the trial and ensure it complies with Good Clinical Practice standards. Securing competent authority and ethical approvals is another task required to be carried out by the supervisor as is the implementation of suitable insurance to cover sponsor liability.

The directive not only stipulates that its requirements are met but it also indirectly creates a significant amount of administrative efforts and paper work. It is vital that any clinical trial taking place in Europe accounts for this added burden in their budget.

Java Clinical Research can undertake many of the roles required of a sponsor as allowed by the EU Clinical Trials Directive. While ultimate responsibility remains with the sponsor Java CR’s experienced team can coordinate with the sponsor to not only carry out the above tasks but to also deal with the administrative tasks created in complying with the directive.

With an in-depth understanding of the responsibilities and requirements of a sponsor under the Directive Java CR can carry out a number of secondary services such as developing study protocols to ICH Good Clinical Practice guidelines and establishing required standard operating procedure.