Tokuda Hospital Sofia

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Document Submission

Submission procedures for new Clinical Trials

I.  Initial Documentation

– all initial documents should be sent to Tokuda Clinical Research Center - e-mail: tcrc@acibademcityclinic.bg

1. Application form 

 Download here 

  • Draft Contracts
  • PI
  • Acibadem City Clinic MHAT Tokuda  EAD / Acibadem City Clinic DCC Tokuda EAD
  • Sub-PIs from other departments, if applicable
  • External Centers, if applicable
  • Total budget per patient and distribution on a visit base
  • Protocol and synopsis
  • Informed consent
  • Declaration/Letter for the required technical equipment, as per Regulation № 31/2007 on establishing guidelines for Good Clinical Practice**
  • Declaration/Letter of Consent art. 87, para. 3 from LMPHM**
  • Details about the transportation costs etc.
  • Insurance, in accordance with LMPHM and Medical Devices Regulations
  • *All the above documents are administered by Tokuda Clinical Research Center.

**Both declarations are signed by the Executive Director only after the review and the approval of the trial by the Committee for Preliminary Control of the Clinical Trials/Studies 

2. Taxes

For information, please contact:

Tokuda Clinical research Center 
phone: +359 02 403 4831, +359 02 403 4838
e-mail: tcrc@acibademcityclinic.bg

 II. Procedure

- Committee for Preliminary Control of the Clinical Trails/Studies

1. Notification – 2 originals
                                   
Download Notification for MHAT                 Download Notification fod MC

2. Protocol synopsis – Bulgarian language
3. Investigator’s Brochure
4. Information for the patients and informed consent – Bulgarian language
5. Any other information, incl. advertising materials

*A hard copy of all the above documents has to be submitted.

**Digital files of the documents from 2 to 5 have to be submitted.    

For more information, please contact:

Tokuda Clinical research Center 
phone: +359 02 403 4838
e-mail: rumyana.gorelska@acibademcityclinic.bg

 

 

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Hospital location

51B Nikola Y. Vaptsarov Blvd., Sofia, 1407 (if you drive, the entrance is from Atanas Dukov str.)

The hospital has a parking lot for patients and visitors. The first 30 min. are free of charge, every next hour is 3BGN/hrs.
IMPORTANT! Have in mind that the parking lot is very busy Monday to Friday between 10.00 and 14.00. The hospital team will appreciate if those whose health condition allow, take the drop off option without parking or use other transport means or alternative parking lots in the area.

Public transport:
Buses: №88, 120

Metro lines: You can get off at James Bourchier or Vitosha metro station and walk to the hospital.

Map 

From the Central Railway Station

Bus: take bus #305 and get off at Romanian Embassy stop, then transfer to bus #120 to Tokuda Hospital stop.

Metro: Take metro line Nadezda-Lozenetz and get off either at James Bourchier or Vitosha metro station, then walk to the hospital.