Clinial trials with medicinal products
In the current situation all applications should exclusively be submitted via e-mail to firstname.lastname@example.org. For details, please refer to the BASG submission guidance, section I.2.
EMA’s Management Board and European Commission confirmed that the clinical trial EU Portal and Database, one of the main deliverables of the Clinical Trial Regulation and the key component of the Clinical Trial Information System (CTIS), is now fully functional and on track to go live by 31 January 2022. The Board confirmed that it has verified that the system meets the agreed requirements during an extraordinary meeting held on 21 April following an independent audit of this new IT system.
Before initiation of any clinical trial an application for approval needs to be submitted to the BASG. You will find a list of the documents necessary for proper submission in the document "List of documents required".
For detailed information on
- Submission of the clinical trial
- Assessment and approval procedure
- Obligations during the clinical trial and
- Obligations after completion of the clinical trial
please refer to the document "Guidelines for the submission of clinical trials according to AMG".
In addition, the general requirements for application of clinical trials with medicinal products of the European Commission (CT-1 Guidance Document, Euralex Vol.10) apply.
The application for approval of the clinical trial needs to be submitted to the responsible (lead) ethics committee before or at the same time as the application to the BASG. Information on the Ethics Commissions in Austria can be found at the Forum of the Austrian Ethics Commissions.
If a clinical trial is to be amended after approval, an amendment may be necessary. The document "Classification of Amendments" describes which changes are subject to approval or reporting by the authority or the Ethics Committee.
Further information on pharmacovigilance in clinical trials (SUSAR and DSUR) can be found here.
The current fees for clinical trials can be found in the BASG ordinance on fees.
The EU/EEA harmonised forms for
- the application for approval of a clinical trial (Annex 1)
- the application for approval of a substantial amendment (Annex 2)
- the notification of the national or global end of the clinical trial (Annex 3)
can be found in the "Eudralex Volume10: Clinical trials guidelines".
Please note that the application form must be created via the EudraCT database. The preparation of the form does NOT constitute a notification to the authority or ethics committee.
Initial applications, amendments and end-of-trial notifications should be submitted electronically via email@example.com.
- Overview of initial applications, procedures and notifications from 2010 to 201906/05/2021