We're sending this special supplement to the October/November newsletter to keep you up to date with recent changes in the regulation of non-interventional studies in Austria.Best wishes,
Tel: +44 (0) 1997 42 33 11
Mobile: +44 (0) 7909 111 510
|Austria: New Reporting Requirements for NIS|
Regulation 180/2010 Sets Down New Requirements for NIS in Austria
According to the Order of the Federal Minister of Health on the reporting of non-interventional studies, the following data in the register are published and publicly available:
which was published on the 17th June 2010 and came into force on the 1st September 2010 sets down new requirements for the conduct and reporting of non-interventional studies in Austria.
According to Regulation 180/2010
- The competent authority (The Federal Office for Safety in Healthcare - BASG) must be notified electronically before such a study can start - This information will be included in an electronic register managed by the BASG
- The NIS can start immediately if a positive ethics committee opinion has been given, or
- If the opinion of an ethics committee is submitted pursuant to Section 41b of the Medicines Act, then the study can be started 21 days after filing
- BASG must be notified of any substantial amendments to the study protocol
- A final study report/report summary must be submitted to BASG 6 months after completion of the study
- Name and address of the person responsible
- Description of the medicinal product / s: n-collection of medicinal products are separated by a comma.
- Projected period, estimated start and completion (In the event of a national study is the date of expected completion in Austria to enter it is a multinational study, the estimated date of completion is entering the world).
- Planned regions following political districts
- Estimated number of participating patients
- Status of the NIS (active, canceled, terminated, completed)
- At the request of the person responsible - if the NIS was canceled - a relevant justification. This requires the selection "If the grounds of abandonment to be published?" Filled with "yes"
- Summary of the Final Report (pdf document)
- Comments of the BASG if necessary
The following is the link to the BASG NIS Registry/Database
In August 2010, the BASG also published a comprehensive guidance document: "Research Guidelines for the Implementation of NIS in Austria
" (In German
The BASG Website also contains a comprehensive list of NIS-related questions and answers: BASG NIS FAQs
Acknowledgements: Dr Julie Meeson of J3i Quality