Clinical trials

Clinical trial statistics

The following document summarises statistics of clinical trials of the past years. The information will also be published in the uptodate-Newslater of the BASG in June.

Ordinance on electronic submission per 1.1.2016!

The new ordinance on electronic submission will apply as per January 1st 2016. It will no longer be required to submit a paper version of the dossier.

The EudraCT application form (PDF and XML) and all documents required for assessment (Protocol, IB, IMPD, ...) need to be submitted in electronic form on an a data medium (e.g. CD).

The data medium and cover letter should be sent to the BASG by regular mail.

General

Information on the submission of clinical trials, the approval procedure, fees and sponsor responsibilities during and after completion of a clinical trial is compiled in the "Guidance for CT submission".

 

Clinical trials require prior approval by the BASG (Federal Office for Safety in Health Care; Bundesamt für Sicherheit im Gesundheitswesen). The "List of Documentation Required" summarises the required dossier content.

 

The cited documents represent the translation of European guidance, which is found in the Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial (CT-1).

 

The submission to Austrian (Lead) Ethics committees is to occur prior or in parallel to the submission to the BASG.

 

An amendment might become necessary should the clinical trial be modified after approval. A tabulated summary of which amendments are considered as substantial and which as non-substantial with the BASG and Ethics committees is provided in the "Classification of Amendments".

Contact

Should our guidance documents not answer your questions, please contact clinicaltrialsagesat

 

Dr. Stefan Strasser

Dr. Ilona Reischl

Downloads

Created: 08.03.2009 | Page last modified: 05.08.2016

© Austrian Federal Office for Safety in Health Care
to top