In the course of clinical trial conduct planning on the territory of Tokuda Hospital Sofia AD, the sponsor files an application for clinical trial conduct at TCRC (draw out the notification).

Enclosed to the application, the sponsor undertakes to send draft agreements (between the sponsor and MHAT Tokuda Hospital Sofia AD and between the sponsor and the principal investigatr) to TCRC on electronic media to tokudaresearchcenter@yahoo.com. TCRC coordinates the draft agreements with the legal, economy, financial and accounting departments. The draft agreements between the sponsor and Tokuda Hospital Sofia AD and between the sponsor and the principal investigator then are brought into line accordingly with the Executive Director of Tokuda Hospital Sofia AD and the principal investigator. The term for approval and signing is about 10 business days.

A document specifying the activities (procedures, check studies and etc.) which are performed upon each visit shall be enclosed to the draft agreements by the sponsor.

Agreements approval procedure with the departments and the application/notification procedure for carrying out of a clinical trial to the Ethics Committee in Tokuda Hospital Sofia AD may be conducted simultaneously.