Latin America is not one regulator. A regional study meets a different agency, ethics system and data law in every country. Capture keeps all of them in one study with identical forms, site-level access and one audit trail.
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Study region
Latin America
Key points for regional studies in Latin America
Why the region
Sponsors add Latin American sites for patient availability, treatment-naive populations, experienced investigators and population diversity. Brazil, Mexico and Argentina have long histories of hosting multinational studies, and Colombia and Chile are common additions to regional programmes. The same sites are also home to locally sponsored academic and investigator-initiated studies.
The challenge is not capturing data once sites are open. It is start-up: separate submissions, import licences for investigational product, translated documents, and ethics committees whose decisions arrive on different days. A data system should let you train site staff and rehearse visits while approvals are pending, then activate each site as it clears. See multi-site clinical trial management.
Pre-launch readiness
1 site activated
1 form not yet approved
At a glance
A starting point for planning conversations. We do not quote approval timelines here because published figures vary widely and mix drugs and devices.
| Country | Regulator and ethics | Data protection | Language |
|---|---|---|---|
| Brazil | ANVISA; CEP/CONEP system via Plataforma Brasil | LGPD | Portuguese |
| Mexico | COFEPRIS; ethics and research committees at sites | Federal personal data law (check current text) | Spanish |
| Argentina | ANMAT; ethics committees at sites | Personal data protection law (check current text) | Spanish |
| Colombia | INVIMA; institutional ethics committees | Personal data law (check current text) | Spanish |
| Chile | ISP; accredited scientific ethics committee | Ley 19.628, then Ley 21.719 | Spanish |
General summary, not legal advice. Confirm every row with the national agency. Country pages: Brazil and Chile are covered in detail on this site.
Control
One study holds every country. Each site has its own participant numbering and its own coordinator portal, sponsor users filter dashboards and exports by site, and edit checks behave identically everywhere. When the protocol is amended, all sites move to the new approved form version together, so you do not end up with Brazilian and Mexican data collected on different definitions.
Baseline severity: moderate
Block 7 of 12
Baseline severity: severe
Block 4 of 12
Baseline severity: moderate
Block 6 of 12
Subject 01-0048 randomized
BlindedRandomization no.
R-0166
Treatment arm
●●●●●●
Emergency unblinding
Built in for blinded designs, when participant safety requires it.
Create the forms, test them in the free sandbox and add country sites as approvals arrive.
Data protection
You do not need a different system per law, but you do need a consistent operating model. Keep identifying data at the site, show sponsor-side users coded IDs, record where data is hosted and the basis for any transfer, and make sure each consent says what happens to the data. Capture separates roles this way: site coordinators see participant names, researchers see coded IDs, and row-level security enforces it at the database layer. Data is encrypted with AES-256 at rest and in transit by TLS.
Country details sit in the dedicated guides: Brazil covers LGPD and the CEP/CONEP system, and Chile covers the ISP, Ley 20.120 and the new data protection law. For the principles behind GDPR-style rules, which several Latin American laws resemble, see GDPR compliant clinical trial software.
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.
Before you start
Which countries open first, and which regulator timelines drive the plan.
Spanish and Portuguese consent, participant information and questionnaire texts; instrument licences held in your study file.
Investigational product import timelines for each country.
Legal basis, transfer basis and pseudonymisation documented.
Exported once and reused in every national ethics package.
Coordinator, researcher and admin accounts created per site.
No. Each country has its own regulator and ethics process. Plan submissions country by country and confirm current rules with each agency.
Yes. One study can hold sites in many countries with site-level access, site-level participant numbering and exports filtered by site.
No. Capture hosts in the EU (Frankfurt) and the USA (N. Virginia). Record the transfer basis in your contracts and consent text.
Participant-facing text is whatever your approved materials say. If you need to understand how a study will handle several languages, talk to us before you commit.
Not to use Capture. The platform is self-serve. You still carry sponsor obligations and the country submissions.
Yes. The free sandbox has every feature with no credit card and no time limit.
Keep exploring
Clinical trial software in Brazil
ANVISA, CEP/CONEP and LGPD.
Clinical trial software in Chile
ISP and Ley 20.120.
Multi-site clinical trial management
Sites across countries.
GDPR compliant trial software
Principles shared by many laws.
Clinical trial software in India
Another large emerging market.
Clinical trial randomization software
Stratify by country.
Same forms, site-level access, one audit trail. Free sandbox.