Chilean trials need an ISP authorisation, a favourable opinion from an accredited ethics committee and a data protection regime that is changing. Capture gives Chilean sponsors and investigators a self-serve EDC, eCRF and eConsent they can build and test free first.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Chile
Key points for studies in Chile
Regulation
A medicinal product trial in Chile has a regulator track and an ethics track. The ISP authorises the study and any importation of investigational product. The ethics track runs through an accredited scientific ethics committee, usually attached to a hospital or university, whose favourable opinion is required under Ley 20.120, and the institution where the study will be run authorises it as well. The investigator then reports progress and a final report to the committee, which is why you want a dataset and an audit trail that can answer committee questions months after approval.
Practical consequence: your submission package will include the protocol, consent form, participant information and a description of the data to be collected. Capture exports a blank eCRF PDF with a cover page, form index, visit-by-form matrix and every approved form printed empty, which is a convenient attachment for the committee. The submission itself is made by you or your CRO. For non-drug studies, devices or observational work, ask the ISP and the committee which route applies; this page cannot decide that for you.
Because the same committee follows the study after approval, amendments to the protocol or to consent text need to be tracked as versions. Capture locks approved forms for live use and keeps a field-level audit trail with timestamp, user, old value, new value and reason for change. See audit trail software for clinical trials.
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.
Data protection
Historically, protection of health data in trials was enforced mostly indirectly, through the ethics committee review under Ley 20.120, because Ley 19.628 is an older and lighter law with no dedicated agency. Ley 21.719 changes that: it creates a Data Protection Agency, strengthens rights and sets clearer legal bases and duties for health data. Whether it applies from December 2026 or a year later depends on the bill now before the Senate, so build a plan that works under either date: a documented legal basis, pseudonymised data for the sponsor, a record of where data is hosted and a transfer basis for any dataset leaving Chile.
In Capture, site coordinators see participant names and researchers and sponsors work with coded IDs, enforced by row-level security in the database. Data is encrypted with AES-256 at rest and TLS in transit, and hosted in the EU (Frankfurt) or the USA (N. Virginia). Hosting abroad means your consent and study agreements should say so. For comparison with another large law, read HIPAA vs GDPR clinical trial data.
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.
Consent
Capture eConsent collects the participant's on-screen signature, verified with a one-time email code, then the investigator countersigns with password re-authentication. Each signature is hashed to the exact document content at signing, and the signed consent exports as a PDF with signature data, timestamps and audit trail. Participant text is whatever your approved Spanish materials say; ask us before you commit if your study needs more than one language.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
Build the forms and sign a test consent in the free sandbox. Go live only when your committee and the ISP have cleared the study.
Chilean research
Chile has a concentrated research base in Santiago and a few other cities, with university hospitals, private clinics and research institutes that take part in multinational programmes as well as locally sponsored studies. Many smaller teams cannot justify an enterprise EDC contract or a full-service CRO for a single-country study. Capture has no setup fee and no per-site fee, and the sandbox is free, so a university team can build a study on its own. See EDC for investigator-initiated trials and clinical trial software without a CRO.
Chile is also a natural part of a wider Latin American programme with neighbouring countries. If you are planning that, the regional picture is in clinical trial software for Latin America, and the Brazilian regime is in clinical trial software in Brazil.
Before you start
Authorisation of the study and import of investigational product, and the right route for non-drug studies.
Favourable opinion, institution authorisation and the progress-report schedule.
Consent, participant information and any questionnaire text, with licences for instruments held in your study file.
Legal basis, pseudonymisation, hosting region and a transfer basis, ready for Ley 21.719.
Attach it to the ethics package.
Site coordinator, researcher and admin accounts, with two-factor authentication turned on for staff.
The Instituto de Salud Pública (ISP) authorises studies with medicinal products. An accredited scientific ethics committee must also give a favourable opinion under Ley 20.120. Confirm the current process with both.
Ley 19.628 today. Ley 21.719 replaces it and creates a Data Protection Agency, but its start date has been scheduled for 1 December 2026 with a bill proposing a postponement, so check the status.
No. Capture hosts in the EU (Frankfurt) and the USA (N. Virginia). Say where data is hosted in your consent and study agreements.
Yes. The platform is self-serve, so a sponsor or university team can build, test and run a study without a service contract. You remain responsible for submissions and sponsor duties.
No regulator approves or certifies EDC software in the way it approves a study. Capture provides controls such as an audit trail and e-signatures; your own validated use and your submissions are what regulators assess.
Yes. The free sandbox has every feature with no credit card and no time limit.
Keep exploring
Self-serve EDC, eCRF and eConsent. Free sandbox, no credit card.