Submission is electronic via the electronic submission system. All required documents must be in PDF format and preferably PDF/A.
Initial submissions are made exclusively via the EC system; subsequent submissions for studies submitted in the ECS from 16 April 2024 must be made exclusively via the ECS. Subsequent submissions, supplements, reports, etc. for studies submitted before 16 April 2024 must be submitted by e-mail or on a data carrier (CD, DVD, USB stick, etc.) as before. The application form must be uploaded to the ECS with all required signatures.
Note: If Med Uni Graz assumes the role of sponsor of the study, sponsorfreigabe(at)medunigraz.at must be stated under application point 1.5.6.
The application is considered to be complete if the following documents have been included:
If required:
If available/applicable:
The application is considered to be complete if the following documents have been included:
If required:
If available/applicable:
The application is considered to be complete if the following documents have been included:
If required:
If available/applicable:
In accordance with the Forum of Austrian Ethics Committees recommendation, the Ethics Committee of the Medical University of Graz currently charges a processing fee of EUR 1,800 for the processing of trials.
This covers all future processing of the trial by the Ethics Committee, SUSAR and side effects, safety reports, amendments, etc.
The processing fee may be waived for non-commercially sponsored ("academic") trials upon request. To distinguish between academic and commercially sponsored trials, there is a leaflet on classifying projects as "commercially sponsored."
The processing fee should be paid to the following account:
Notifications of changes in the trial plan, incidents, terminations of the trial, etc. are continually accepted (without any submission deadline) and processed. In the event of amendments or serious, undesirable events, comments and a statement on any change in the benefit/risk ratio are required. Notifications should also be submitted electronically.
The Ethics Committee reserves the right to allow applications to be examined by external experts. This assessment is comparable to the review procedure in a scientific journal. The external experts - who remain anonymous to the applicants - are obliged to treat the documents provided to them as confidential. The applicants may receive the assessment and make a statement.
According to the ICH-GCP guideline (Good Clinical Practice), which includes at least one annual review of ongoing trials, a positive decision by the Ethics Committee is valid for one year from the date it was issued. If the trial lasts longer, an extension of the validity of a positive decision must be applied for in due time using the form for interim and final reports/application for an extension. These applications are handled like other notifications to the Ethics Committee, i.e., they are also examined at short notice outside the regular meetings. It may be necessary to handle them in a committee meeting.
Reports should also be submitted electronically.
