Costa Rica regulates biomedical research through a dedicated law and a national health research council. Capture is a cloud, self-serve EDC your team or CRO can set up without local IT, hosted in the EU or the USA, and testable free before go-live.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Costa Rica
Key points for studies in Costa Rica
Regulation
Costa Rica's law on biomedical research, Law 9234, and its regulation set the framework for studies on human participants. Per secondary sources, CONIS sits within the Ministry of Health structure and works alongside scientific ethics committees (CECs) at institutions such as hospitals that have the accreditation to host them. Sponsors normally submit the protocol, consent documents, investigator and site details and the data-handling description for review before any participant is enrolled. Your CRO, local legal adviser or the site's research office will know the current forms and fees.
What the submission needs from a data system is a clear description 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 supports the protocol and the ethics package. Reviewers and inspectors also expect an inspectable record: every field change in Capture 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.
Consultancy blogs quote everything from 30 to 90 days to several months. Those are marketing pages, not regulator statements. Ask CONIS and your ethics committee for their current expectations in writing before you plan a start-up date.
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 |
|---|---|---|---|
| Protocol and consent submission | Sponsor or CRO, with the site | Protocol, consent, investigator and site details | Blank eCRF PDF of approved forms. |
| National and ethics review | CONIS and the ethics committee | Risk, consent, data protection | eConsent record with countersignature and signed PDF. |
| Site start-up | Hospital or clinic, principal investigator | Agreement, delegation, training | Site accounts, roles and site-level participant numbering. |
| Data collection | Site coordinators | Source documents, visit data | Edit checks, auto-queries and calculated fields. |
| Oversight | Sponsor monitors, authorities | Source verification, safety reporting, audit trail | SDV per field, queries, field-level audit trail. |
Roles summarise secondary sources. Confirm national detail with CONIS and your ethics committee.
Build the visit schedule, forms and checks free, give your regulatory lead the blank eCRF PDF, and pay only when real participants enrol.
Data protection
Capture hosts studies in the EU (Frankfurt) or the USA (N. Virginia), chosen at setup. Neither is in Costa Rica. Whether participant data may be stored or accessed abroad, and what consent wording that requires, is a legal question under Costa Rican law; ask your counsel or the site's research office rather than assuming either region is acceptable. Many sponsors of Costa Rican sites are based in the USA or Europe, so the question is often already answered in the sponsor's master agreements.
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. For how a data protection agreement for an EDC is usually structured, read GDPR compliant clinical trial software and HIPAA vs GDPR clinical trial data; neither is a statement about Costa Rican law.
EU (Frankfurt)
Default for EU-sponsored studies
US (N. Virginia)
Default for US-sponsored studies
Consent
Because Costa Rican sources stress informed consent, treat the consent record as a primary document. 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, each signature is hashed to the exact document content, and the signed PDF carries the timestamps and audit trail. The consent wording is yours. Language support is not claimed here, so if Spanish materials must be delivered inside the platform, ask us what is currently available before you plan around it.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
Operating reality
Sites are concentrated around the San José metropolitan area, with hospitals and private clinics hosting studies. A common pattern is a sponsor elsewhere adding Costa Rican sites to a multinational or regional protocol. That makes site-level participant numbering and by-site exports useful, so Costa Rican data can be reviewed on its own. The QR enrolment link needs no app, which suits sites without dedicated IT support.
Regional pages: Latin America, Colombia, Brazil, Argentina and Chile. For running sites across borders, read multi-site clinical trial management.
Before you start
Confirm with CONIS and the site which ethics committee reviews, and get timing in writing.
Ask counsel whether a local representative or CRO is needed for your sponsor type.
Approved Spanish consent text and participant information; decide how it is delivered.
Consent wording and legal basis for storing or accessing data abroad.
Who reports serious events to whom and by when.
Audit trail description, role matrix and hosting region for your vendor assessment.
Per secondary sources, trials fall under Law 9234 of 2014 and its regulation, with review by the National Health Research Council (CONIS) at the Ministry of Health and an accredited ethics committee. Confirm current procedures with CONIS.
No. Capture is hosted in the EU (Frankfurt) and the USA (N. Virginia). Ask counsel whether storing data abroad needs specific consent wording.
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 is assessed.
No. Capture is self-serve with no office, partner or CRO in Costa Rica.
This page does not claim multilingual participant materials. Contact us about current language support before you commit to Spanish ePRO or consent screens.
Sources conflict, from about 30 to 90 days to several months. Ask CONIS and the ethics committee for current expectations rather than relying on blogs.
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 Latin America
Regional overview.
Clinical trial software in Colombia
Neighbouring region.
Clinical trial software in Brazil
The largest regional market.
eConsent software
On-screen consent with countersignature.
HIPAA vs GDPR clinical trial data
How regimes compare.
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.