Austria

Austria

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

Verified on January 13, 2022

Austria has 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 is mandatory in BASG (NIS).

Registries at a Glance
Registry PHUSE Categorization Information to be Entered By Route of Data in Registry Study Type Language
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 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

Yes

Prior to enrollment
Results

Yes

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.
  • Results are required to be posted on EudraCT per European Directive 2001/20/EC.

Registry Updates


References


  1. Clinical Trial Application Form. European Clinical Trials Database. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/application-form_en.pdf. Published November 28, 2019. Accessed November 28, 2019.
  2. Frequently asked question regarding BASG (NIS) database. https://www.basg.gv.at/gesundheitsberufe/klinische-studien/nicht-interventionelle-studien-nis/faq-nis