Germany and Austria sit inside the EU Clinical Trials Regulation. Switzerland sits outside it and has its own two-track approval. Capture lets a DACH study run all three in one EU-hosted database.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Germany, Austria, Switzerland
Key points for DACH studies
Regulation
A DACH programme is really two regulatory worlds. Germany and Austria use CTIS: one application, joint Part I assessment, national Part II. A German application is allocated to a registered ethics committee under a nationwide plan, so the responsible committee is not known in advance; a 2024 proposal for a central federal ethics committee was contested by the medical profession, and you should check its status. Switzerland keeps a separate system: Swissmedic reviews the product, quality and safety dossier, the competent cantonal ethics committee reviews the ethics and legal aspects, and the two approvals are independent. Exemptions exist, for example for trials with authorised medicines used within their authorisation, so ask early which route applies.
The practical effect on data is small but real. A Swiss site may have a different approval date, a different consent version and different documents from a German site, yet the sponsor needs the same forms and checks everywhere. For the German detail see clinical trial software in Germany, and for the EU framework see EU CTR clinical trial software.
Treat Switzerland as its own submission stream with its own timetable. One Capture study can hold German, Austrian and Swiss sites together, with site-level participant numbering, a separate site coordinator portal and exports filtered by site. If the Swiss committee requires a change, the approved form version moves for the whole study through your normal amendment, not through three parallel databases. See ECRF versioning for mid-study changes.
Randomized
166 / 240
Open queries
24
Fields verified
84%
3 open queries · 92% SDV
7 open queries · 85% SDV
14 open queries · 61% SDV
0 open queries · 100% SDV
Site risk
Site 03 query backlog
Data lock
Site 04 ready to lock
Data protection
Germany and Austria apply GDPR with national and, in Germany, state-level rules on top, and hospital and research laws can add conditions. Switzerland applies its revised Federal Act on Data Protection. The EU and Switzerland generally recognise each other's level of protection, but whether that settles a transfer to a Frankfurt-hosted database for your study is a question for your data protection officer and the Swiss ethics committee, not something to assume.
Capture hosts study data in Frankfurt with AES-256 at rest and TLS in transit, and separates roles so that site coordinators see participant names while researchers and sponsors see coded IDs, enforced by row-level security at the database layer. The wider picture is in GDPR compliant clinical trial software. Capture has no region inside Germany, Austria or Switzerland, which matters only if your institution requires in-country storage.
Site coordinator
Jane Peterson
DOB: 04-Mar-1978
Subject 01-004
Sees direct identifiersResearcher
Subject 01-004
DOB: withheld
Coded ID only
Sees coded ID onlySame record, two roles. Row-level security enforces the split.
At a glance
| Question | Germany | Austria | Switzerland |
|---|---|---|---|
| Submission route | CTIS (EU CTR with AMG) | CTIS (EU CTR) | BASEC and Swissmedic (Human Research Act) |
| Authority decision | BfArM, Part I | BASG decision in CTIS | Swissmedic, where authorisation applies |
| Ethics review | Registered state ethics committee, allocated by plan | Ethics committee per national cooperation | Competent cantonal ethics committee |
| Document language | German | German | Depends on canton: German, French or Italian |
| Data protection | GDPR, national and state rules | GDPR, national rules | Swiss federal data protection act |
General practice summary, not legal advice. Confirm with BfArM, BASG, Swissmedic and the competent ethics committee.
Consent
Each country may end with a different approved consent text. Capture eConsent links every signature to the exact document content at signing, collects the participant's on-screen signature with an email one-time code and the investigator's countersignature with password re-authentication, and exports the signed consent as a PDF with timestamps and audit trail.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
The sandbox has the same features as a live study, so you can run your user acceptance testing on your own forms. No credit card.
The DACH ecosystem
DACH has dense networks of university hospitals, coordinating centres for clinical trials and a large pharmaceutical and medtech sector, alongside many biotech start-ups and university spin-outs. That produces two sponsor types: industry teams that need data controls an inspector will trust, and academic teams that carry sponsor duties on a grant. Neither wants a long contract. Capture has no setup or per-site fee, and you pay only once real participants are enrolled. See validation by sponsors and Annex 11 versus 21 CFR Part 11 for the control expectations that DACH inspectors and auditors commonly discuss.
Before you start
CTIS for Germany and Austria; Swissmedic and cantonal ethics committee for Switzerland.
German for DE and AT; the canton's language for Swiss sites.
GDPR basis, Swiss law position, hosting region and pseudonymisation in your DPIA.
Each approved text is the one participants sign.
Exported for each ethics package.
Site coordinator, researcher and admin accounts per site.
No. Switzerland applies the Human Research Act. Swissmedic and the competent cantonal ethics committee issue separate approvals, with applications through BASEC.
Under CTIS, applications are allocated to a registered committee through a nationwide allocation plan, so the committee is not known in advance. Confirm the current rules with BfArM.
Capture hosts in the EU (Frankfurt) and the USA (N. Virginia). Frankfurt is in Germany, but Capture does not offer a region in Austria or Switzerland, and does not claim a Swiss data residency.
Yes. One study can hold sites in all three, with site-level access, site-level participant numbering and exports filtered by site.
Yes. See the Germany guide for the German-specific detail.
Yes. The free sandbox has every feature, with no credit card and no time limit.
Keep exploring
Clinical trial software in Germany
German detail.
EU CTR clinical trial software
CTIS, Part I and Part II.
GDPR compliant trial software
EU data protection.
Annex 11 vs 21 CFR Part 11
Control expectations compared.
Clinical trial software in Central and Eastern Europe
The eastern neighbours.
EDC UAT and sandbox
Test before go-live.
EU-hosted EDC, eCRF and eConsent. Free sandbox, no credit card.