Argentina has a new ANMAT clinical trial regime from December 2025, ethics committees accredited province by province, and a data protection law that restricts transfers to countries without adequate protection. Capture keeps Argentine sites in one global study, hosted in the EU or US.
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Study region
Argentina
Key points for studies in Argentina
Regulation
For years the rules for clinical pharmacology studies in Argentina rested on Disposicion 6677/2010 and later amendments. Law-firm bulletins report that ANMAT replaced that framework with Disposicion 7516/2025, which sets out Good Clinical Practice and the evaluation and oversight of studies for registration purposes. It covers Phase I, II and III studies and protocol changes, formally adopts the ICH E6 (R3) guidance and, according to one firm, also repealed several complementary dispositions and circulars. A transition rule keeps older pending procedures under the old regime.
A cautionary note: a 2026 CRO guide still lists the 2010 disposition, which suggests secondary sources are lagging. Read the 2025 text in the Boletin Oficial and confirm with ANMAT or your Argentine CRO before basing a plan on any summary. Capture follows a risk-based and flexible-build approach to data capture, and makes no claim of formal alignment to ICH E6 (R3). Your own validated use is what regulators look at.
What this means for the data system is the same under either regime: inspectors expect traceable records. Every change in Capture carries timestamp, user, old value, new value and reason for change, the trail is append-only and always exportable, and electronic signatures are linked to the signing user. See audit trail software for clinical trials and 21 CFR Part 11 compliant EDC.
Because Argentina is a federation, the City of Buenos Aires and the provinces run their own central ethics committees, which accredit and supervise institutional committees in their territory. A study at sites in several jurisdictions can therefore meet several committee structures. Ask each site which committee reviews you and whether a centralised arrangement is possible. See also how to get IRB approval.
What changed
Confirm every row against the Boletin Oficial text and ANMAT guidance.
| Topic | Disposicion 6677/2010 (previous) | Disposicion 7516/2025 (reported) | Planning note |
|---|---|---|---|
| Status | Core GCP framework for registration studies since 2010 | Effective 1 Dec 2025, replaces 6677/2010 | Check which regime governs a pending application. |
| Scope | Clinical pharmacology studies | Registration studies, new indications or doses, Phases I to III | Non-registration and non-interventional studies appear to be outside it. |
| GCP standard | GCP annex of the 2010 rule | Adopts ICH E6 (R3) guidance | Capture states no formal R3 alignment. |
| Transition | n/a | Procedures pending at 1 Dec 2025 stay under the old regime | Ask ANMAT how your timing is treated. |
| Exclusions | Bioequivalence rules separate | Bioequivalence and bioavailability excluded | Separate rules apply to those. |
Data protection
Argentina protects personal data through Ley 25.326, often called the habeas data law, supervised by the AAIP. Health data is sensitive and has stricter treatment, and patients have separate rights under health laws, including on the confidentiality of clinical records. The law generally prohibits sending personal data to countries or international bodies that do not provide adequate protection, with exceptions, including the data subject consent and certain medical cases. The authority also recognises contractual routes: model clauses for transfers between controllers and to processors approved in 2016, the Ibero-American Network clauses adopted by the AAIP in October 2023, and binding corporate rules guidelines from 2018.
The AAIP has also published a list of jurisdictions it treats as adequate. We could not confirm from our sources whether it covers the USA, and reports suggest it includes EU countries, so check the current list. With Capture, Argentine data goes to Frankfurt or N. Virginia. If the destination is covered by an adequacy finding, the question is simpler; if not, consent and model clauses between the sponsor, the institution and any processor are the usual route. Counsel should decide.
Put the transfer in the participant information and consent. Capture hosts in the EU or US only, encrypts with AES-256 at rest and TLS in transit, and keeps identity at the site: coordinators see participant names, researchers see coded IDs through row-level security. See GDPR compliant clinical trial software for the principles Argentine clauses often mirror.
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.
Sign a test consent and set site coordinator and researcher roles in the free sandbox.
Consent
Capture eConsent collects the participant on-screen signature, verified with 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 document content at signing. The signed consent exports as a PDF with timestamps and audit trail. Whether electronic consent is accepted at your site, and the Spanish text, are for your ethics committee and your own translators. This page makes no claim about built-in Spanish language support.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
Argentine research
Argentina has a long record in clinical research, with experienced investigators in Buenos Aires, Cordoba and Rosario, strong public and private hospitals and academic networks. It features in multinational programmes alongside Brazil, Chile, Colombia and Mexico, and the same sites also run investigator-initiated and observational studies.
For regional planning read clinical trial software for Latin America, then the neighbouring guides for Brazil, Chile and Colombia. Capture stratified randomization and site-level numbering keep Argentine sites distinct from the rest in one design: see clinical trial randomization software and EDC for Phase 3 clinical trials.
Typical start-up
A sketch for planning, not a regulatory timeline.
Check that your plan follows the current ANMAT disposition and any transition rule.
Find which institutional committee and which central committee apply at each site.
Protocol, consent in Spanish, investigator brochure and the blank eCRF PDF from Capture.
Consent wording and model clauses for EU or US hosting, agreed with counsel.
Create site accounts, train coordinators and enrol once approvals are in the file.
Before you start
Application under the current disposition, with transition status checked.
Institutional committee approval, with the accrediting central committee identified per jurisdiction.
Consent, participant information and questionnaire text approved by the committee, prepared by your team.
Transfer basis for EU or US hosting, consent wording and model clauses.
Public registration as required by national rules and sponsor policy.
Coordinator and investigator accounts matched to delegation.
ANMAT regulates clinical pharmacology studies, and ethics committees review each study. Secondary sources say Disposicion 7516/2025 replaced Disposicion 6677/2010 from 1 December 2025. Confirm the current rule with ANMAT.
Law-firm summaries say it was repealed with effect from 1 December 2025, with pending procedures staying under the old regime. Some guides still cite it, so read the Boletin Oficial text and ask ANMAT.
Institutional committees review studies, and provinces and the City of Buenos Aires have central committees that accredit them. Ask each site which applies.
It generally prohibits transfers to countries without adequate protection, with exceptions such as consent, and the AAIP publishes model clauses and a list of adequate jurisdictions. Ask Argentine counsel about the EU and US destinations.
No. Capture hosts in the EU (Frankfurt) and the USA (N. Virginia). Document the transfer basis in consent and contracts.
This page makes no claim about Spanish language support. Prepare approved Spanish materials with your own translators and ask in a demo what is available.
No regulator approves EDC software of this kind. Capture provides an audit trail, e-signatures and access controls. Your validated use is what is assessed.
Yes. The free sandbox has every feature, with no credit card and no time limit.
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Same forms, checks and audit trail everywhere. Free sandbox.