Peruvian trials are authorised by the national health institute INS with a DIGEMID opinion on investigational products and an accredited ethics committee. Capture is a self-serve cloud EDC hosted in the EU or US that you can test free first.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Peru
Key points for studies in Peru
Regulation
A medicine trial in Peru involves three parties with different jobs: INS authorises the study, DIGEMID opines on the investigational product and its import, and an accredited ethics committee approves it ethically. Foreign sponsors often ask whether a local representative or CRO is required; our sources do not settle that, so ask INS or local counsel. Handbooks from 2019 may predate later changes, so use them for structure only.
All three reviewers want to see what is collected. Capture exports a blank eCRF PDF with cover page, form index, visit-by-form matrix and every approved form empty to attach as supporting detail. Good clinical practice expectations are in our good clinical practice glossary entry, and how to get IRB approval covers the ethics side.
Inspectors trace records. Capture logs timestamp, user, old value, new value and reason for each field change, in an append-only trail. 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
Peru's personal data protection law, Law 29733, regulates processing of personal data, including sensitive data such as health information, and includes rules on cross-border flows. Our search did not return how those rules apply to trials, so settle it with Peruvian counsel before sending identifiable data abroad. Many trials use coded data with keys held at the site.
Be direct about hosting. Capture's regions are Frankfurt and N. Virginia. Data from Peruvian participants is processed outside Peru, and participant information should say so. If counsel or the committee requires in-country hosting, Capture should not be assumed to fit.
Use the role split to limit what travels: site coordinators see participant names while researchers see coded IDs, enforced at the database. Data is encrypted with AES-256 at rest and TLS in transit. See HIPAA vs GDPR clinical trial data for how other regimes treat the same questions.
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.
Create site and researcher roles in the free sandbox and check that coded IDs behave the way your counsel needs.
Due diligence
| Question | Why it matters | What Capture can offer |
|---|---|---|
| Can trial data be hosted outside Peru? | Determines whether an EU or US hosted system is acceptable. | Frankfurt or N. Virginia only; document it in the vendor file. |
| Is a local sponsor representative required? | Drives INS submissions and import handling. | No local entity; your team or CRO runs the study. |
| Which ethics committee reviews? | Affects start-up time per site. | Site accounts and by-site filtering once cleared. |
| What happens on protocol amendment? | INS and the committee review changes. | Draft to approved form lifecycle; approved forms are locked for live use. |
| What will an inspector trace? | Who changed what, when and why. | Field-level audit trail, e-signatures, query history. |
Capture is not a legal adviser. Confirm every row with Peruvian counsel or your CRO.
Consent
Capture eConsent records an on-screen participant signature with an email one-time code, then investigator countersignature with password re-authentication. Witness and legally authorised representative signatures are supported, which can matter where literacy or guardianship questions arise. The wording is yours; Spanish-language screens are not claimed on this page, so check what is currently available, and plan for connectivity since offline entry is not claimed.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
Typical start-up
A planning sketch, not a regulatory timeline.
Get written advice on processing coded data in Frankfurt or N. Virginia.
Check the current unit, forms and any representative requirement.
Build forms and checks in the sandbox with site staff.
Include it as supporting detail for INS and the committee.
Create site accounts after each committee approval.
Research landscape
Peru runs trials in Lima and at regional centres, and is often one country among several in Andean or Latin American programmes. Infectious disease, oncology and public health studies are common. For comparison see Latin America, Colombia, Chile, Brazil and Argentina.
Academic investigators can use the free sandbox to prove a design before funding commits. See EDC for academic clinical trials.
The INS authorises trials, DIGEMID gives a technical opinion on investigational products and an accredited ethics committee approves them. Confirm current procedure with INS.
No. Capture is hosted in the EU (Frankfurt) and the USA (N. Virginia). If your study must keep data in Peru, get legal advice and do not assume Capture fits.
The law covers sensitive data and cross-border flows, but our sources did not detail how it applies to trials. Ask Peruvian counsel for your study.
No. Capture is self-serve with no office, partner or CRO in Peru. Appoint a local representative separately if your sponsor needs one.
No regulator approves EDC software that way. Capture offers an audit trail, e-signatures and access controls, and your validated use is what is assessed.
This page does not claim multilingual participant screens. Ask us about current language support before designing a Spanish ePRO or consent flow.
Yes. The free sandbox has every feature with no credit card and no time limit. You pay only when you go live with real participants.
Keep exploring
Clinical trial software in Latin America
Regional view.
Clinical trial software in Colombia
Neighbouring regime.
Clinical trial software in Chile
Neighbouring regime.
Clinical trial software in Brazil
Largest regional market.
Audit trail software
Evidence for inspectors.
Free sandbox demo
See the platform with a demo study.
Build the study, check the role split and show your counsel before any fee. Pay only at go-live.