Swiss trials usually need two authorisations, from Swissmedic and a cantonal ethics committee, and run under Swiss data protection law rather than the EU one. Capture hosts in the EU (Frankfurt) or the US, not in Switzerland, so this page covers what that means.
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Study region
Switzerland
Key points for Swiss studies
Regulation
Clinical research in Switzerland is governed mainly by the Human Research Act (HRA) and its ordinances, the Therapeutic Products Act, the Clinical Trials Ordinance (ClinO) and, for devices, ClinO-MD. Trials are classified into categories A, B and C by risk. Sources describe that, for categories B and C, the sponsor submits to Swissmedic and in parallel to the cantonal ethics committee responsible for the study site, each issuing its own decision, and that the trial cannot start until both are in hand. Ethics submissions go through BASEC, the online portal of the ethics committees; the umbrella body is swissethics.
Our search found no confirmation of a single joint submission route between BASEC and Swissmedic, and the 2024 revision introduced time limits rather than merging the two tracks. Plan for two dossiers and two sets of amendment submissions. Swissmedic publishes a guideline on amendments (version 12.1 valid from June 2025) and a submission form for changes and reporting such as first participant first visit, interruption and completion.
For the data system, both authorities will care about the same things: a protocol-consistent eCRF, a trial master file that can be inspected, consent documentation, and a complete audit trail. Capture can export a blank eCRF PDF (cover page, form index, visit-by-form matrix and every approved form) for the ethics dossier, and keeps a field-level append-only audit trail. See the eCRF builder and essential documents checklist for ICH-GCP.
Data protection
Switzerland is outside the EU and has its own Federal Act on Data Protection (FADP) with a data protection ordinance. Health data is sensitive personal data. Transfers abroad generally need an adequate level of protection in the destination, or safeguards such as standard contractual clauses adapted for Swiss law, or another listed exception. Commentary notes that EU adequacy decisions are not automatically Swiss ones, and that cantonal health-data and professional-secrecy rules can apply to patient data held by hospitals, so research projects need their own legal check.
In practice, a Swiss sponsor using Capture is transferring coded study data to a service hosted in Germany or the US. Ask your data protection adviser and ethics committee which basis applies, what the participant information sheet must say, and whether the processing agreement needs Swiss clauses. A design that limits what moves helps: site coordinators see participant names while researchers see coded IDs, enforced by row-level security, and data is encrypted at rest (AES-256) and in transit (TLS). See EU-US data privacy framework for clinical research, GDPR compliant clinical trial software and pseudonymization vs anonymization.
Classify the data
Identifiable, coded, genetic. Ask your adviser what each counts as.
Choose a transfer basis
Adequacy, adapted clauses, or an exception.
Check hospital and cantonal rules
Patient data held by sites may have extra limits.
Write it into consent and agreements
Recipients, location, retention.
Set up site and researcher roles in the free sandbox, then show the design to your data protection adviser.
Consent
Participants sign on screen after an email one-time code; the investigator countersigns with password re-authentication and a meaning statement. Witness and legally authorised representative signatures are supported, each signature is hashed to the document content, and the signed PDF exports with timestamps and audit trail. Whether electronic consent is accepted at a given Swiss site, and what the information sheet must contain, is for your ethics committee to decide.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
Due diligence
| Question | Why it matters | What Capture offers |
|---|---|---|
| Which category is the trial? | Determines whether Swissmedic authorisation is needed. | Phase 1 to 3 drug and observational study set-up; category is your decision. |
| Can coded data go to EU or US hosting? | FADP transfer rules and cantonal rules. | Hosting in Frankfurt or N. Virginia only; no Swiss hosting claim. |
| Will participant materials be in German, French or Italian? | Ethics committees expect understandable consent. | Not claimed here; confirm in a demo. |
| Who sees identifiable data? | Minimisation and professional secrecy. | Coordinators see names, researchers see coded IDs; row-level security. |
| What will inspectors ask for? | Audit trail, signatures, delegation. | Field-level audit trail, e-signatures, signed consent PDF. |
| Is the result data submitted for transparency? | Registration and results duties under the revised rules. | SDTM export (SAS XPT with Define-XML) and CSV with data dictionary. |
Capture is not a legal adviser. Confirm each answer with counsel and the authorities.
Research landscape
Switzerland combines university hospitals, a strong pharma and biotech base and multi-centre networks, and Swiss sites often join studies led from the EU or US. A trial that spans Swiss sites and EU member states faces two regimes: the EU Clinical Trials Regulation for member states and Swiss rules for the Swiss part. Read EU CTR clinical trial software and EU CTIS submission guide alongside this page, and compare neighbouring Germany.
With a common platform, approved forms are identical at every site, site-level participant numbering keeps records apart (for example 001-0042), and exports filter by site. See multi-site clinical trial management.
Before you start
Swissmedic authorisation where required, and the cantonal committee for each site.
Written view on FADP and cantonal rules for coded data in EU or US hosting.
Approved text and languages, signed through the eConsent flow if accepted.
Trial registration before start and results summary timelines noted.
Coordinator and researcher views checked in the sandbox.
Who files protocol amendments with both Swissmedic and the committee.
No. Capture hosts in the EU (Frankfurt) and the USA (N. Virginia). Whether coded Swiss trial data may be processed there depends on Swiss data protection and cantonal rules and your ethics committee. Get advice first.
Sources describe Swissmedic and the responsible cantonal ethics committee each issuing an approval for trials in categories B and C, and both are needed before starting. Confirm the category and route with the authorities.
The online submission system of the Swiss ethics committees. Sponsors file their ethics applications there. Swissmedic receives its own submission separately.
A partial revision was adopted on 7 June 2024 and took effect on 1 November 2024, with transparency provisions from 1 March 2025. It introduced two-year limits for the second authorisation and for first enrolment. Read the current Swissmedic guidance.
It took effect on 15 September 2024 and covers only US organisations that have certified under it. Capture does not claim to be certified; do not rely on it unless the provider confirms.
Participant-facing language support is not claimed on this page. Ask us in a demo about your specific materials.
No regulator approves EDC software this way. Capture gives you an audit trail, e-signatures and access controls; your validated use and submissions are what authorities assess.
Yes. The free sandbox has every feature, no credit card and no time limit; you pay only when you go live with real participants.
Keep exploring
Clinical trial software in Germany
Neighbouring EU country guide.
EU CTR clinical trial software
The EU regime next door.
GDPR compliant clinical trial software
Transfer principles for EU hosting.
EU-US data privacy framework
US transfers explained.
Multi-site trial management
One study across countries.
eConsent software
Consent records for ethics review.
Build and test your study free, then take the hosting question to your adviser. Pay only at go-live.