Austria

Austria

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

Verified on September 9, 2021

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


  • September 2021: EU CTIS Webinar - European Medicines Agency updated about the upcoming Clinical Trials Information System- Webinar for small and medium-sized enterprises (SMEs) and academia over the What’s New Section on September 10, 2021: The webinar will be conducted on November 29, 2021, for the small and medium-sized enterprises (SMEs) and academic sponsors of clinical trials. The agenda of the … Continue reading "September 2021: EU CTIS Webinar"
  • September 2021: CTIS Training Update - European Medicines Agency updated the page Clinical trials information system (CTIS): online modular training programme by adding a PDF in Module 19: Quick guide – Introduction: CTIS for SMEs and Academia on September 07, 2021. The document consists of a brief introduction to CTIS and its timeline. It also explains in detail about clinical trial … Continue reading "September 2021: CTIS Training Update"
  • September 2021: CTIS Training Updates - European Medicines Agency updated the page name of Clinical Trials Information System: training programme to Clinical trials information system (CTIS): online modular training programme, on September 03, 2021. The below documents were also updated in CTIS Training Module 03 (User access management) and new versions of documents were added in Module 19 (CTIS for SMEs and … Continue reading "September 2021: CTIS Training 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