Indonesian trials need BPOM authorisation and a separate ethics committee approval, and trial data sits under the Personal Data Protection Law. Capture is a self-serve EDC hosted in the EU or US that you can build and test free first.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Indonesia
Key points for studies in Indonesia
Regulation
A trial of a medicine in Indonesia is assessed by BPOM on its scientific and administrative content. Law-firm and consultancy guides say the dossier includes the protocol, informed consent form, investigator information and preclinical or earlier clinical data, and that BPOM and the ethics committee work in parallel but separately. The exact documents, timelines and any local-representation requirement for foreign sponsors should be checked with BPOM or a local CRO, since the old handbooks we found predate the 2024 regulation.
The ethics approval comes from an accredited health research ethics committee, usually the committee at the principal site. Multi-site trials often need each site's committee to confirm, depending on the institution. Whichever committee reviews your study, it will want to see what is collected from participants. Capture exports a blank eCRF PDF (cover page, form index, visit-by-form matrix and every approved form empty), which is also useful for a Good Clinical Practice review. For the principles behind that review, see good clinical practice and how to get IRB approval.
Regulators inspect records, so the data system needs a clean audit trail. Capture records the timestamp, user, old value, new value and reason for each field change, and the trail is append-only. 21 CFR Part 11 compliant EDC explains the controls behind that.
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
The Personal Data Protection Law was enacted in 2022 with a two-year transition, which is generally understood to have ended in October 2024. It treats health data as specific personal data, requires a lawful basis for processing, and sets conditions for transfers abroad. Practitioners note that overseas data flows are routine in trials, since sponsors, CROs and central labs are often outside Indonesia, and that the law has to be met whichever way the data moves. How the transfer conditions are met in practice, for instance by relying on consent or on safeguards in contracts, is something to settle with counsel because the sources we reviewed did not set it out.
Be direct about hosting. Capture's regions are Frankfurt and N. Virginia. If you enter data from Indonesian participants, it is processed outside Indonesia, and the participant information should say so. If counsel or the ethics committee tells you data must stay in Indonesia, Capture should not be assumed to fit and you should choose a system hosted there.
To limit what travels, use the role split: site coordinators see participant names, while researchers see coded IDs, enforced by row-level security. 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 Indonesia? | Determines whether an EU or US hosted system is acceptable. | Frankfurt or N. Virginia only; document it in your vendor file. |
| What is the lawful basis and consent wording? | The PDP Law and the ethics committee both look at it. | eConsent record with signed PDF; the wording is your approved text. |
| Is a local sponsor representative or CRO required? | Often drives submissions and site management. | No local entity; your team or CRO runs the study. |
| How many ethics committees must review? | Affects start-up time across sites. | Site accounts and by-site filtering once each site is cleared. |
| What will an inspector want to 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 Indonesian counsel or your CRO.
Participant reporting
Indonesia spans thousands of islands, and many participants will complete a questionnaire on a phone. Capture supports QR-code enrolment with no app install and ePRO diaries on phone browsers, with reminders and a compliance view for the team. Local-language participant screens are not claimed on this page, so confirm what is currently available before designing around Bahasa Indonesia. Offline entry is also not claimed, so plan for connectivity at remote sites.
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Typical start-up
A planning sketch, not a regulatory timeline.
Get written advice on whether coded data may be processed in Frankfurt or N. Virginia.
Decide whether a local CRO or representative handles BPOM and ethics submissions.
Build forms and checks in the sandbox and have site staff test entry.
Include it with the BPOM and ethics packages as supporting detail.
Create site accounts only after each committee approval is in hand.
Research landscape
Indonesia is the region's largest population and a growing destination for vaccine, infectious disease, oncology and metabolic studies, with academic centres in Jakarta, Bandung, Yogyakarta and Surabaya. Academic investigators often run observational and phase 2 work with small teams, for whom a free sandbox and no setup fee lower the cost of getting started. See EDC for academic clinical trials.
For comparison with neighbouring regimes read Malaysia, Singapore and the wider Southeast Asia guide. For a country with a similar South Asian approval-plus-ethics pattern, see Pakistan.
BPOM authorises the trial and a health research ethics committee approves it ethically. Commentary says one does not replace the other. Confirm current procedures, including BPOM Regulation 8 of 2024, with BPOM or a local CRO.
No. Capture is hosted in the EU (Frankfurt) and the USA (N. Virginia). If your study must keep data in Indonesia, get legal advice and do not assume Capture fits.
The law sets conditions for overseas transfers, and trial data commonly goes to sponsors and CROs abroad. Our sources did not detail the mechanism, so ask Indonesian counsel for your study.
No. Capture is self-serve with no office, partner or CRO in Indonesia. Appoint a local representative separately if your sponsor needs one.
This page does not claim multilingual participant screens. Ask us about current language support before designing a Bahasa Indonesia ePRO or consent.
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.
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 Pakistan
DRAP and the Clinical Studies Committee.
Clinical trial software in Malaysia
Neighbouring regime.
Clinical trial software in Singapore
HSA and the PDPA.
Southeast Asia overview
Regional view.
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.