Portuguese trials need an ethics opinion from the CEIC and authorisation from INFARMED, under a national law that is being aligned with the EU regulation. Capture is a self-serve EDC hosted in Frankfurt that you can test free first.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Portugal
Key points for studies in Portugal
Regulation
Portugal keeps two keys for a trial: INFARMED, the medicines authority, and the CEIC, the ethics committee. Under Law 21/2014 the sponsor applies to each, and authorisation follows a positive ethics opinion. Because the country has been updating its national law to match the EU regulation, older commentary may describe a procedure that no longer applies. For the EU side read our EU CTIS submission guide and EU CTR clinical trial software.
A data system supports the application with a clear picture of what is collected. Capture exports a blank eCRF PDF (cover page, form index, visit-by-form matrix and every approved form empty). After approval, inspectors and monitors want traceability, and every field change in Capture carries timestamp, user, old and new value and reason, in a trail that cannot be edited through the interface. See audit trail software for clinical trials.
A summary of the Portuguese framework notes that ethics approval is also a basis for exempting recruitment sites' data protection officers from a further assessment. That makes the data protection description in the dossier matter twice. Prepare a short description of roles, hosting and encryption early so the site DPO can reconcile it with the protocol.
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.
Routes
| Study type | Reported route | What to confirm | Where Capture helps |
|---|---|---|---|
| Medicinal product trial | CTIS, INFARMED authorisation with a positive CEIC opinion | Current post-2026 deadlines and fees | Blank eCRF PDF, audit trail description. |
| Medical device investigation | Single dossier to INFARMED and CEIC via the national registry | Registry steps and device class | Forms and device-event capture in the same study. |
| Non-interventional study | Ethics and data protection focus; route varies | Whether CEIC or another committee applies | Role split and coded IDs for analysis. |
| Legacy Directive trial | Moved to the CTR and CTIS by 30 Jan 2025 | Whether your file was transitioned | Continuity of the audit trail for ongoing data. |
Based on law-firm summaries. Confirm with INFARMED and the CEIC.
Build the forms free, export the blank eCRF PDF and describe roles and hosting before any fee. Pay only when participants enrol.
Data protection
Portuguese trial data is personal data under the GDPR, and health data is a special category. The national supervisor is the Comissão Nacional de Proteção de Dados (CNPD). Capture hosts in the EU (Frankfurt) and the USA (N. Virginia), so a Portuguese study can keep storage in the EU. Remote access from outside the EU, for example by a monitor, should be reviewed with your DPO.
Role-based access means 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. See GDPR compliant clinical trial software and GDPR DPIA template for clinical trials.
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.
Consent
Capture eConsent combines an on-screen participant signature, an email one-time code, and investigator countersignature with password re-authentication. Witness and legally authorised representative signatures are supported. The wording is yours and must match what the CEIC approved; Portuguese-language screens are not claimed here, so ask us what is currently 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
••••••••••
Before you start
Confirm Law 21/2014 as amended, including the 2026 changes, and whether your study is CTIS, device or non-interventional.
Know which CEIC reviews and what it needs, since INFARMED authorisation follows it.
Approved Portuguese consent and participant information, version controlled.
Processor agreement, records of processing, transfer analysis for non-EU access.
Who reports SUSARs and to which system.
Audit trail description, role matrix and hosting region for site DPOs.
Research landscape
Portuguese hospitals in Lisbon, Porto and Coimbra take part in both multinational programmes and investigator-led research. For academic teams the cost of getting started matters, and the free sandbox lowers it. See EDC for academic clinical trials.
Compare neighbours and similar regimes: France, Italy, Germany and multi-site clinical trial management.
INFARMED is the competent authority for medicines trials and the CEIC gives the ethics opinion. Law-firm summaries say authorisation depends on a positive CEIC opinion. Confirm current procedure with both.
A secondary source reports Law No. 9/2026 of 6 March amended Law 21/2014 to align with the EU regulation. We have not read the official text, so check it before relying on this.
No. Capture hosts in the EU (Frankfurt) and the USA (N. Virginia). Frankfurt keeps Portuguese study data in the EU. There is no Portuguese 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 Portuguese ePRO or consent flow.
Summaries describe a different route where one dossier reaches INFARMED and the CEIC through a national registry. Confirm which applies to your device.
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 France
Another EU CTR market.
Clinical trial software in Italy
Southern European sites.
EU CTR clinical trial software
What the regulation asks of the data system.
GDPR DPIA template
Prepare the data protection assessment.
EDC for academic trials
Investigator-led studies.
Pricing
Free sandbox, pay at go-live.
Build, test and export the blank eCRF PDF before any fee. You pay only when real participants enrol.