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.
- BASG CLTR CT Statistics 2016 EN.pdf112 KStatistics of clinical trials (cutoff 2015)
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.
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".
Should our guidance documents not answer your questions, please contact clinicaltrialsagesat
Dr. Stefan Strasser
Dr. Ilona Reischl
- L I209 Guidance CT submission en.pdf239 KGuidance for submission of a clinical trial [Last updated: 05.08.2016]
- L I211 List of documentation required.pdf41 KList of documentation required for valid submission to the BASG [Last updated: 21.12.2015]
- L I219 Classification of Amendments.pdf153 KClassification of Amendments [Last updated: 02.09.2014]
- CT-1 English version 02.pdf867 KCT-1 Guidance Document [30.03.2010]
- L I220 Entscheidungsbaum Arzneimittelgesetz.pdf179 KDecision tree for classification of a clinical trial (German only) [Last updated: 21.07.2014]
Created: 08.03.2009 | Page last modified: 05.08.2016