Austrian Clinical Research Infrastructures Network

Multinational Trials

The aim of the Austrian Clinical Research Infrastructures Network AtCRIN is to support non-commercial investigator-initiated multinational trials. This will be achieved in close collaboration with ECRIN, which provides access to clinical trial infrastructure in various countries. AtCRIN provides the national hub to help investigators in the submission, conduct, and quality control of clinical studies.


Ethics committee

Composition and obligations of research ethics committees are regulated in the drug act (Arzneimittelgesetz, AMG) and for hospitals in the hospital act (Krankenanstalten- und Kuranstaltengesetz, KAKuG).
The application for studies with an investigational medicinal product to the lead ethics committee in multicentre trials (and in parallel to the local ethics committee) is mandatory for initial submission and for amendments. Links and submission forms are provided by the Forum Österreichischer Ethikkommissionen .

 

Competent authority

The CA in Austria is the Bundesamt für Sicherheit im Gesundheitswesen (BASG, Federal Office for the Safety in Health Care), supported by AGES Medizinmarktaufsicht (Austrian Medicines Agency).
BASG

Traisengasse 5A-1200 Vienna
+43 (0) 50 555-36111
clinicaltrials@ages.at

 

Regulatory submission

The application to the ethics committee concerned can be submitted prior to or simultaneously with the application to the BASG.
The clinical trial application can be considered approved if the BASG has not raised an objection within the 35 days period stated in the 'confirmation of formal completeness' letter (implicit silent approval, exceptions exist for ATMP and other study interventions). The approval is also published on the website of the BASG.
A Table of the submission requirements for the different types of studies can be found here:

 

Rare diseases

The scientific secretary of the European Union Committee of Experts on Rare Diseases publishes a regular report in collaboration with the competent authorities on the activities in EU Member States.

Country report Austria:

More information about the European Expert committee is available at EUCERD .

The full reports on rare diseases can be found on Orphanet .



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