SSInvestigator object

Additional Information

• Investigator: a physician or dentist authorised to carry out a clinical trial. If only one investigator is involved in a clinical trial of a medicinal product he/she is also regarded as the principal investigator.
The investigator must fulfil suitable qualification as to education and professional expertise to be allowed to carry out a clinical trial.
• Principal investigator: The investigator responsible for the implementation of a clinical trial of a medicinal product at each research centre. In certain instances the principal investigation may also be a sponsor, cf. item i.
• Supervisor of the trial: The principal investigator who co-ordinates implementation of clinical trials on medicinal products in the Icelandic centres involved in a multi-centre trial.
(Art 2 & Art 25 Regulation no 433/2004)

Details to study responsibilities of investigators, principal investigators and sponsors are specified in Art 4 Regulation no 443/2004.