In Austria the ethics committee assesses both parts of the CTIS dossier and BASG authorises the trial. Capture is a self-serve EDC hosted in Frankfurt that Austrian sites can test free before go-live.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Austria
Key points for studies in Austria
Regulation
A sponsor files a single CTIS application. In Austria the ethics committee does the scientific and the national assessment, and BASG takes the formal decision. That differs from member states where the medicines agency leads Part I. For a sponsor it means the committee is the main reviewer of the protocol and the consent, so what you submit about data collection reaches them directly. Read our EU CTIS submission guide and EU CTR clinical trial software for the EU procedure.
Capture exports a blank eCRF PDF (cover page, form index, visit-by-form matrix and every approved form printed empty) that shows reviewers exactly what a site enters. Afterwards, inspectors want traceability, and every field change carries timestamp, user, old and new value and reason in a trail that cannot be edited via the interface. See audit trail software for clinical trials.
Austria's faster aim of 35 or 60 days is described for mononational trials. A multinational CTIS dossier follows the EU regulation's own coordinated timelines. Ask BASG which applies before you set start-up dates for a single-country investigator-led study.
Blank eCRF · no subject data
Visit by form matrix
| Form | SCR | D1 | W2 | W4 | W8 | EOS |
|---|---|---|---|---|---|---|
| Demographics | X | |||||
| Vital signs | X | X | X | X | X | X |
| Laboratory | X | X | X | |||
| ECG | X | X |
3. Was the ECG performed?
☐ Yes☐ No
If No, complete question 4.
DACH context
| Topic | Austria | Germany | What it means for the data system |
|---|---|---|---|
| Competent authority | BASG | BfArM or Paul-Ehrlich-Institut | Separate regulator contacts per country. |
| Ethics review | Ethics committee assesses Part I and II | Committee allocated nationally | Prepare the same protocol package, expect different reviewers. |
| Mononational aim | 35 or 60 days stated by BASG | Check BfArM | Do not copy one timeline to another country. |
| Hosting | Frankfurt EU region available | Frankfurt EU region available | One database can hold sites in both countries. |
Summary only. See the Germany and DACH pages and confirm details with each authority.
Build the visit schedule, forms and checks free, hand the blank eCRF PDF to your committee contact, and pay only when real participants enrol.
Data protection
Austrian trial data is personal data under the GDPR, with national rules in the Datenschutzgesetz (DSG), supervised by the Datenschutzbehörde. Our search did not return how the DSG treats research data, so ask your data protection officer. Capture hosts in the EU (Frankfurt) and the USA (N. Virginia). For an Austrian study Frankfurt keeps storage in the EU.
Site coordinators see participant names while researchers see coded IDs, enforced by row-level security. Data is encrypted with AES-256 at rest and TLS in transit. Read GDPR compliant clinical trial software and the DACH overview.
EU (Frankfurt)
Default for EU-sponsored studies
US (N. Virginia)
Default for US-sponsored studies
Consent
Since the ethics committee reviews consent in depth, keep one approved version. Capture eConsent records the participant's on-screen signature with an email one-time code, then the investigator's countersignature with password re-authentication, plus witness or legally authorised representative signatures when needed. Each is hashed to the document content. German-language participant screens are not claimed here, so check what is available.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
Typical start-up
A sketch, not a regulatory timeline.
Decide mononational or multinational and which ethics committee will assess.
Describe forms, roles, hosting and audit trail for the dossier.
Build in the sandbox and have Austrian site staff test entry.
Include it with the supporting detail.
Create site accounts as sites finish start-up.
Research landscape
Austria's medical universities in Vienna, Graz and Innsbruck run both industry and academic trials, and Austrian sites often join studies led from Germany or Switzerland. By-site exports and site-level participant numbering keep their data separable. See multi-site clinical trial management.
Related pages: Germany, Switzerland, Czech Republic and Hungary.
BASG is the competent authority under EU Regulation 536/2014, supplemented by the Austrian Medicines Act. Ethics committees assess the dossier too. Confirm current procedure with BASG.
BASG states an aim of 35 days without deficiencies or 60 days with, for mononational trials from 22 April 2025. Multinational dossiers follow EU timelines. Confirm with BASG.
No. Capture hosts in the EU (Frankfurt) and the USA (N. Virginia). Frankfurt keeps Austrian study data in the EU. There is no Austrian data centre or office.
No regulator approves EDC software that way. Capture provides an audit trail, e-signatures and role-based access, and your validated use is what is reviewed.
This page does not claim multilingual participant screens. Ask us about current language support before designing a German-language ePRO or consent flow.
Yes, as sites in one study with site-level numbering and by-site filtering. Each country still needs its own approvals.
Yes. The free sandbox has every feature, with no credit card and no time limit. You pay only when you go live with real participants.
Keep exploring
Clinical trial software in Germany
BfArM and German committees.
DACH overview
Germany, Austria, Switzerland.
Clinical trial software in Switzerland
Swissmedic route.
EU CTIS submission guide
How the EU portal works.
GDPR compliant clinical trial software
Processor and hosting questions.
Pricing
Free sandbox, pay at go-live.
Build, test and share the blank eCRF PDF before any fee. You pay only when real participants enrol.