South African trials need SAHPRA authorisation and research ethics committee approval, and identifiable trial data sits under POPIA. Capture is a self-serve EDC hosted in the EU or US that you can build and test free.
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Study region
South Africa
Key points for studies in South Africa
Regulation
SAHPRA authorises trials and any import of unregistered investigational products. Section 21 of the Medicines Act is the legal basis for that authorisation. Ethics approval comes from a research ethics committee, usually at the university or hospital hosting the study, and a multi-site protocol often needs each site's committee to agree or accept a lead opinion. We found no current guidance on how committee approval interacts with SAHPRA for multi-country studies, so ask SAHPRA and your committee.
Both reviewers want to know what is collected from participants. Capture exports a blank eCRF PDF (cover page, form index, visit-by-form matrix and every approved form empty) to attach as supporting detail. For the ethics principles behind that review, read how to get IRB approval and good clinical practice.
After approval, inspectors look at 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
South Africa's Protection of Personal Information Act is supervised by the Information Regulator and treats health information as special personal information, with conditions for processing it. Commentary says a research exemption exists in principle, a draft Research Code was proposed to explain it, and that cross-border rules for health data were described as unclear in the draft materials. Whether coded data sent to a sponsor or EDC abroad is identifiable depends on who holds the key.
State hosting plainly. Capture's regions are Frankfurt and N. Virginia. Data from South African participants is processed outside South Africa, and participant information should say so. If counsel or your committee requires in-country hosting, Capture should not be assumed to fit.
To limit what travels, use the role split: 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 identifiable trial data leave the country? | POPIA transfer conditions for health data. | Frankfurt or N. Virginia only; coded IDs for analysis users. |
| Which ethics committees must approve? | Affects start-up time across sites. | Site accounts and by-site filtering once each site is cleared. |
| Is a local sponsor or CRO required? | Often drives SAHPRA submissions and monitoring. | No local entity; your team or CRO runs the study. |
| How are protocol amendments tracked? | SAHPRA needs approval of amendments. | 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 South African counsel or your CRO.
Enrolment and diaries
South African studies, including infectious disease and public health work, often enrol at clinics and community sites with participants on mobile phones. Capture supports QR-code enrolment with no app install and ePRO diaries in phone browsers, with reminders and a compliance view. Offline entry and local-language screens are not claimed on this page, so plan for connectivity and confirm language support first.
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Print it on posters and clinic flyers
Typical start-up
A planning sketch, not a regulatory timeline.
Get written advice on whether coded and identifiable data may be processed in Frankfurt or N. Virginia.
Decide whether a local CRO or representative handles SAHPRA and ethics submissions.
Build forms and checks in the sandbox with site staff.
Include it as supporting detail for SAHPRA and the committee.
Create site accounts after each committee approval is in hand.
Research landscape
South Africa has long-established university research units in Johannesburg, Cape Town, Durban and Pretoria and a large share of the continent's registered trials. Academic investigators with small teams can use the free sandbox to prove a design before funding commits. See EDC for academic clinical trials.
SAHPRA authorises trials, with Section 21 of the Medicines Act covering unregistered medicines, and a research ethics committee approves them ethically. Confirm current procedures with SAHPRA.
No. Capture is hosted in the EU (Frankfurt) and the USA (N. Virginia). If your study must keep data in South Africa, get legal advice and do not assume Capture fits.
Commentary says rules for cross-border transfers of identifiable health information are ambiguous in draft materials. Ask South African counsel what applies to your study.
No. Capture is self-serve with no office, partner or CRO in South Africa. 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 around isiZulu, Afrikaans or other languages.
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
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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.