Brazil offers large, diverse, often treatment-naive populations and experienced research centres. Capture runs Brazilian sites in the same study as the rest of the world, with the same forms, checks and audit trail.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Brazil
Key points for studies in Brazil
Research landscape
Brazil has a large population, a public health system that treats many patients who are naive to newer therapies, and research centres with long experience of international trials, particularly in oncology, cardiology, infectious disease and vaccines. Including Brazilian sites can speed enrolment and broaden the diversity of a study population.
Historically, regulatory and ethics timelines have been the main planning challenge, which is why start-up should begin early and site activation should be tracked closely. Once sites are open, they should work exactly like every other site: same forms, same checks, same audit trail. See multi-site clinical trial management.
The LGPD includes specific provisions for research and treats health data as sensitive, with conditions for processing and for transfers to other countries. Keep identifying data at the site, pseudonymise what the sponsor sees, and document the transfer basis for the hosting region you choose. In Capture, sponsor-side users see coded participant IDs, and PII segregation is enforced at the database layer.
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.
Start-up
Each site passes an activation checklist before it can enrol: ethics approval, contract, initiation visit and delegation log. Brazilian sites can be added to the study and trained while approvals are pending, then activated as soon as the checklist is complete.
Pre-launch readiness
1 site activated
1 form not yet approved
Build and test the study in the free sandbox; go live when sites are approved.
Before you start
For medicinal product trials.
CEP/CONEP via Plataforma Brasil, under the current law.
Processing basis, sensitive data safeguards and transfer basis.
Approved consent and participant texts; official instrument translations.
Investigational product import timelines planned.
Ethics approval, contract, initiation visit and delegation log.
Participant protections
Brazilian research ethics has long placed strong emphasis on participant protection. Ethics guidance has traditionally required that participants who benefit from an investigational treatment continue to have access to it after the study, and the 2024 research law also addresses post-trial provision. Plan post-trial access with the sponsor and ethics committees early, because it affects budgets, supply and the consent text.
Rules on reimbursing participants' expenses, and on compensation and assistance for harm related to the research, are also written into the consent. Check the current requirements for your study type under the 2024 law, and make sure the approved consent version is the one each participant signs.
Consent version tracking, adverse events followed to resolution with outcome recorded, and a clean record of each participant's end of study status all support these obligations. In Capture, consent is signed on screen with a verified signature and linked to the exact document version, and AEs carry onset, outcome and resolution dates. See eConsent software.
Planning
| Area | What to plan |
|---|---|
| Regulatory and ethics | ANVISA and ethics submissions started early; timelines tracked per site. |
| Investigational product | Import licences and customs lead times. |
| Materials | Portuguese consent, participant texts and official instrument translations. |
| Data protection | LGPD legal basis, sensitive data safeguards and international transfer basis. |
| Post-trial access | Agreed approach reflected in the protocol and consent. |
| Site activation | Activation checklist complete before first enrolment. |
ANVISA, Brazil's national health regulatory agency, regulates clinical trials of medicines.
Through the CEP/CONEP system of local and national ethics committees, with submissions via Plataforma Brasil. A 2024 law reorganised research ethics review, so confirm the current process.
Brazil's general data protection law, which treats health data as sensitive and regulates international transfers.
Capture hosts study data in the EU (Frankfurt) or the US (N. Virginia), chosen at study setup, with AES-256 encryption at rest and TLS in transit. Assess the cross-border transfer rules that apply to your study before choosing.
Yes. The free sandbox has every feature with no credit card and no time limit.
Keep exploring
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A major Brazilian trial area.
Study start-up software
Site activation.
Free sandbox with every feature. No per-site fee.