Spain combines an AEMPS assessment with a binding opinion from an accredited ethics committee (CEIm). Capture is a self-serve EDC hosted in Frankfurt that Spanish sites can test free before go-live.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Spain
Key points for studies in Spain
Regulation
A sponsor files one application in CTIS. Spain assesses its national items alongside the shared assessment: the AEMPS evaluates and the chosen CEIm issues an ethics opinion, and the integrated result is positive only when both are positive. For the EU procedure, read our EU CTIS submission guide and EU CTR clinical trial software.
What the dossier and the CEIm need from a data system is a clear picture of what is collected and how it is protected. Capture produces a blank eCRF PDF with a cover page, form index, visit-by-form matrix and every approved form printed empty, which suits the protocol and the ethics package. Every field change carries a timestamp, the user, the old and new value and the reason, and the trail cannot be edited through the interface. See audit trail software for clinical trials.
Because one accredited CEIm opinion is nationally valid, the choice of committee matters for timing, and it must be one that takes part in CTIS review. Ask the sites and the AEMPS list which committees are open to a new application, and what each needs from the data management plan.
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.
Who does what
| Step | Who | What is needed | Where Capture helps |
|---|---|---|---|
| Dossier submission | Sponsor or legal representative in the EU | Protocol, IB or IMPD, consent, site and investigator details | Blank eCRF PDF of the approved forms. |
| Regulatory assessment | AEMPS | Design, safety, quality, endpoints | Edit checks and derived fields documented in the form. |
| Ethics opinion | Accredited CEIm | Consent, recruitment, site suitability, data protection | eConsent record with countersignature and signed PDF. |
| Site start-up | Hospital, principal investigator, hospital management | Agreement, delegation, training | Site accounts, roles and site-level participant numbering. |
| Ongoing oversight | Sponsor monitors, inspectors | Source verification, safety reporting, audit trail | SDV per field, queries, field-level audit trail. |
Roles summarise secondary sources and the regulation. Confirm national detail with the AEMPS and the CEIm.
Build the visit schedule, forms and checks free, hand the blank eCRF PDF to your regulatory lead, and pay only when real participants enrol.
Data protection
Trial data is personal data under the GDPR, and health data is a special category. The Spanish data protection authority (AEPD) supervises, alongside the national organic law that adapts the GDPR. Capture hosts in the EU (Frankfurt) and the USA (N. Virginia). For a Spanish-site study the Frankfurt region keeps storage inside the EU. Whether access from a third country by a CRO or monitor amounts to a transfer is a question for your data protection officer.
In Capture, site coordinators see participant names while researchers see coded IDs, and row-level security enforces that at the database. Data is encrypted with AES-256 at rest and TLS in transit. Read GDPR compliant clinical trial software and the GDPR DPIA template for clinical trials.
EU (Frankfurt)
Default for EU-sponsored studies
US (N. Virginia)
Default for US-sponsored studies
Consent
The CEIm reviews the participant information and consent text, so the consent in the system must be the approved version. Capture eConsent takes the participant on-screen signature, confirmed by a one-time email code, then the investigator countersigns with password re-authentication. Witness and legally authorised representative signatures are supported, and each signature is hashed to the exact document content. The signed PDF carries timestamps and the audit trail. Language support is not claimed here, so confirm what is available before planning Spanish, Catalan, Basque or Galician screens.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
Research landscape
Spain is among the larger EU trial countries by volume, with hospital-based research institutes in Madrid, Barcelona, Valencia, Seville and elsewhere, run through regional health services. A study often adds Spanish sites to a multinational programme, which makes site-level participant numbering and by-site exports useful: Spanish data can be reviewed and reconciled without opening other countries.
For nearby markets read France, Italy and Belgium. For running sites across borders, read multi-site clinical trial management. For Spanish-speaking markets outside Europe see Latin America.
Before you start
Pick an accredited CEIm that is on the AEMPS list of committees taking part in CTIS review.
Name the EU legal representative if the sponsor is outside the EU.
Approved participant information and consent, and a plan for how each version is delivered.
Processor agreement, records of processing, transfer analysis for any non-EU access.
Hospital contracts and regional health service requirements, with timing built into the plan.
Audit trail description, role matrix and hosting region for your vendor assessment.
Medicinal product trials run under EU Regulation 536/2014 and Royal Decree 1090/2015. The AEMPS is the national contact point and an accredited CEIm gives the ethics opinion. Confirm current procedures with them.
Secondary sources describe the CEIm opinion as binding and valid nationwide. Sites still have their own agreements and management approvals. Confirm with the AEMPS and your chosen CEIm.
For medicinal product trials under the EU regulation, yes. The CEIm you choose must have signed the CTIS collaboration memorandum, and the AEMPS publishes the list.
No. Capture is hosted in the EU (Frankfurt) and the USA (N. Virginia). For a Spanish study the Frankfurt region keeps data in the EU. Capture has no Spanish data centre or office.
No regulator approves EDC software in that way. Capture provides an audit trail, e-signatures and role-based access, and your validated use is what an inspector looks at.
This page does not claim multilingual participant materials. Contact us about current language support before you commit to Spanish or co-official language screens.
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 Belgium
FAMHP and the College.
Clinical trial software in France
Neighbouring EU market.
Clinical trial software in Italy
Southern Europe sites.
Clinical trial software in Latin America
Spanish-speaking regions beyond Europe.
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.