SSInvestigator object

Entitled to be principal investigator

According to Art 4 (25) AMG

Additional Information

Definition of Investigator (pursuant to Art 4 (25) AMG):
"generally a physician responsible for the conduct of the clinical trial on human beings at a site or, in justified exceptional cases, another person whose profession, owing to the scientific requirements and the experience in the care of patients which it calls for, qualifies him/her to conduct research on human beings. If a clinical trialis being conducted at one site by a team of persons, the investigator shall be the person in charge of the team and responsible for conducting the trial. If a clinical trial is being conducted at various trial sites, the sponsor shallname one investigatoras the chief investigator."

The duties of the PI regarding the completion of the trial can be found in section 12 GCP-V.

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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