Colombian trials run under INVIMA oversight, Resolucion 2378 de 2008 and institutional ethics committees, with Ley 1581 and the SIC governing personal data and transfers. Capture keeps Colombian sites in one study with a full audit trail, hosted in the EU or US.
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Study region
Colombia
Key points for studies in Colombia
Regulation
INVIMA is the national regulator for drug clinical research. Resolucion 2378 de 2008 makes GCP mandatory and describes the roles of the sponsor, investigator, institution and ethics committee. In practice a drug trial needs INVIMA approval of the protocol and product plus approval from the ethics committee at each participating institution, and INVIMA can halt a study over non-compliance or a public health risk. Medical device studies are handled through a separate INVIMA group, so a device trial follows a different file.
The ethics committee sits inside the research institution, and the institution is responsible for keeping it compliant with the technical annex. For multicentre studies, each site committee reviews, and sponsors normally coordinate through a Colombian CRO or local representative. Capture does not provide that representation. It supplies the data system your team or CRO configures.
Two features matter at inspection. The audit trail records timestamp, user, old value, new value and reason for change on every field, and the trail cannot be modified in the interface. The blank eCRF PDF, with form index and visit-by-form matrix, gives committees a clean view of what is collected. See audit trail software for clinical trials and how to get IRB approval.
Studies that do not test a medicine still need ethics review, and Resolucion 8430 de 1993 classifies research by risk. Low-risk observational and registry work is common in Colombian hospitals and universities. See EDC for observational studies and EDC for registry studies.
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
Ley 1581 de 2012 is Colombia's general data protection law, with the SIC as the authority. Health data is sensitive, so processing generally needs the express authorisation of the data subject, who must be told which data is sensitive and that they need not provide it. Data controllers also have registration and policy duties that a Colombian lawyer will walk you through, and the law distinguishes a transfer to a controller from a transmission to a processor.
For international movement, the law prohibits transferring personal data to countries that do not provide an adequate level of protection, with exceptions that include the express and unequivocal authorisation of the data subject. The SIC lists countries it considers adequate. We did not retrieve the current list or the text of the SIC circular on model clauses that reportedly came out in December 2025, so check both and decide, with counsel, whether the EU and US destinations are covered or whether authorisation and contractual clauses are the route.
Capture hosts in Frankfurt or N. Virginia, so Colombian data is processed abroad. Name the regions in the authorisation and consent form and in the clinical trial agreement. Role-based access gives site coordinators participant names and researchers coded IDs, enforced by row-level security, with AES-256 at rest and TLS in transit. See GDPR compliant clinical trial software for comparable transfer principles.
Sites active
4 of 5
Randomised
38
Open queries
12
Consents pending
3
Site 001
Site 002
Site 003
Site 004
Create site accounts, enrol sample participants and check site-level reports in the free sandbox.
Terms
| Term | Meaning | Why it matters for data |
|---|---|---|
| INVIMA | National regulator for medicines, devices and food. | Approves or issues no-objection for drug trials and can halt studies. |
| Resolucion 2378 de 2008 | GCP resolution for drug clinical research. | Sets GCP duties and the roles of committees and institutions. |
| Comite de etica en investigacion | Institutional research ethics committee. | Approves the study at each site; needs consent and the eCRF description. |
| IPS | Health service provider institution that hosts research. | Often needs GCP certification to host drug trials, per vendor guides. |
| Habeas data | The constitutional right behind Ley 1581. | Shapes authorisation wording for personal data. |
| SIC | Superintendencia de Industria y Comercio, the data authority. | Source of transfer guidance and model clauses. |
Consent
Capture eConsent records the participant on-screen signature, verified with a one-time email code, followed by the investigator countersignature with password re-authentication. Each signature is hashed to the exact document content signed. Because Ley 1581 expects express authorisation for sensitive data, include the data processing text in the same approved document so the record shows what was agreed. The Spanish text is prepared by your team, and 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
••••••••••
Colombian research
Colombia is a frequent member of Latin American programmes with sites in Bogota, Medellin, Cali and Barranquilla, specialised hospitals and an active contract research community. Sponsors use it for oncology, cardiology and rare disease studies alongside neighbouring countries. See EDC for oncology clinical trials and EDC for cardiology clinical trials.
For regional planning start with clinical trial software for Latin America, then the guides for Argentina, Brazil and Chile. Multi-country designs need consistent definitions and a clear way to report by country: see multi-site clinical trial management.
Typical start-up
A sketch for planning, not a regulatory timeline.
Confirm that each institution holds the INVIMA certification vendor guides describe, and has a compliant ethics committee.
Protocol, product data, consent with data authorisation and the blank eCRF PDF.
Submit through your representative or CRO and each site committee.
Authorisation wording and contractual clauses for EU or US hosting, agreed with counsel.
Create site accounts, train coordinators and enrol once INVIMA and committee decisions are on file.
Before you start
Obtained before the first participant, for drug studies.
Each committee approves the protocol, consent and participant information.
Certification checked for every site, per INVIMA guidance.
Express authorisation for sensitive data and transfer wording in the consent.
Contract clauses for EU or US hosting, checked against current SIC guidance.
Consent and questionnaire text approved by committees, prepared by your team.
INVIMA oversees clinical research with medicines, under Resolucion 2378 de 2008, and institutional ethics committees review each study. Confirm current requirements with INVIMA.
A vendor guide says institutions hosting drug trials need INVIMA GCP certification valid for five years. Check this with INVIMA and each site.
Ley 1581 de 2012, supervised by the Superintendencia de Industria y Comercio. Health data is sensitive and international transfers are limited. Ask Colombian counsel about your study.
The law prohibits transfers to countries without adequate protection, with exceptions such as express authorisation. Check the SIC list and the 2025 model clause circular with counsel.
No. Capture hosts in the EU (Frankfurt) and the USA (N. Virginia). Name the regions in authorisation 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.
Keep exploring
Clinical trial software in Argentina
ANMAT and Ley 25.326.
Clinical trial software in Brazil
The largest regional market.
Clinical trial software in Chile
ISP and Ley 20.120.
Clinical trial software for Latin America
The regional picture.
EDC for oncology trials
Common in regional programmes.
EDC for observational studies
Registries and low-risk research.
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