Austria

Austria

Austrian Federal Office for Safety in Health Care (BASG) Non Interventional Studies (NIS)

Verified on December 2, 2022

Austria had its own clinical trials registry, Austrian Federal Office for Safety in Health Care (Non Interventional Studies) [BASG (NIS)] which has provision to publish protocol registration and summary reports of the results. Posting protocol registration and submitting results of non-interventional clinical trials was mandatory in BASG (NIS). However, from 07 October 2022, [BASG (NIS)] is permanently closed for registration of non-interventional trials. From 31 January 2022, European Union Clinical Trial Information System (EU CTIS) has become functional and Clinical Trials Regulation (Regulation (EU) No 536/2014) is now applicable. EU CTIS will support both protocol registration and results posting activities for clinical trials conducted in EU/EEA.

Registries at a Glance
Registry PHUSE Categorization Information to be Entered By Route of Data in Registry Study Type Language
EU CTIS Not Applicable Competent authority, Sponsor Clinical Trial Application

Interventional

(Phase 1-4)
English
EU CTR EU CTR via Clinical Trial Applications Competent authority Clinical Trial Application

Interventional

(Phase 1-4)
English
EU PAS EU PAS - ENCePP (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance [PASS & PAES requirements]) Sponsor Through a dedicated registration platform (process independent from clinical trial application) Post-authorization Safety Efficacy Studies English
BASG (NIS) Mandatory National Database (includes Ethics Requirement) Sponsor Through a dedicated registration platform (process independent from clinical trial application)

Observational

German
Registration and Results Requirements
Registry Activity Legal Requirement Timing
EU CTIS Registration

Yes

Prior to enrollment
Results

Yes

Intermediate summary of results - within 12 months of the interim data analysis date; Final summary of results and lay person summary - within 12 months from the end of trial in EU/EEA (Non-paediatric Studies); within 6 months from the end of trial in EU/EEA (Paediatric Studies)
EU CTR Registration

Yes

Prior to enrollment
Results

Yes

Within 12 months of Study Completion (Non-paediatric Studies); Within 6 months of Study Completion (Paediatric Studies)
EU PAS Registration

Yes

Before the start of data collection
Results

Yes

Within 12 months of the end of data collection
BASG (NIS) Registration

No

Prior to enrollment
Results

No

Within 12 months of Study Completion

Other Mandatory Requirements


  • A Clinical Trial Application (CTA) is required to be submitted to the national competent authorities (NCA) – BASG by the sponsor via EudraCT or EU CTIS.
  • Results are required to be posted on EudraCT per European Directive 2001/20/EC or on EU CTIS per Clinical trial regulation (EU) No 536/2014.

Registry Updates


References