Kenyan trials need Pharmacy and Poisons Board authorisation, ethics clearance and a clear plan for sending data abroad. Capture is a browser-based EDC and ePRO platform that university teams and sponsors can set up themselves, without a licence negotiation.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Kenya
Key points for studies in Kenya
Regulation
In Kenya, medicinal product trials are authorised by the PPB. Ethics review sits with an accredited ethics committee, which for many academic studies is a hospital or university committee, such as the joint committee of Kenyatta National Hospital and the University of Nairobi, or an institution-specific body. Research permits through NACOSTI sit alongside. Sponsors based abroad frequently need a Kenyan institution as partner or host. These are three conversations with different timelines, so start them in parallel and track them in the same plan.
The software is not the regulator's concern, but your documentation will be. Reviewers commonly ask what data is collected, who sees it, where it is stored and how participants consent. Capture helps you answer: it exports a blank eCRF PDF for the protocol package, role-based access separates identities from coded data, and consent is signed electronically with a verified signature and exportable audit trail. See good clinical practice for the expectations behind these questions.
Behavioural, diagnostic, device and observational studies are not authorised by the PPB in the same way as drug trials. Ethics clearance and a research permit usually still apply, and the PPB may need to be consulted for devices or products. Confirm the right route with your ethics committee at the start.
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 Data Protection Act 2019 treats health data as sensitive and sets duties for the controller and processor. Its Part VI covers transfers of personal data out of Kenya, and the Data Protection (General) Regulations 2021 add detail: transfers need an appropriate safeguard, an adequacy decision by the Commissioner, necessity or explicit consent, and each transfer should be documented. The Commissioner can also restrict transfers. The Act contains an exemption provision for research, but its conditions are specific, so do not assume a trial automatically qualifies. Ask your institution's data protection officer or counsel.
A defensible set-up for an international study usually combines three things: pseudonymised data for the sponsor, a contract that records the transfer basis, and consent text that tells participants their coded data is hosted outside Kenya. In Capture, site coordinators see participant names while researchers and sponsors see coded IDs, enforced by row-level security, and data is encrypted with AES-256 at rest and TLS in transit. You choose between Frankfurt and N. Virginia at study setup; neither is in Kenya.
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.
Participants
Participants answer ePRO questionnaires in a mobile browser by following a link, with no app to install, and reminders are sent by email. That removes app-store, storage and operating-system problems from the picture. Phone-based entry still needs data coverage on the participant side, so for studies where this is a concern keep a plan for site-assisted completion.
Evening diary
Question 3 of 8
How would you rate your fatigue today?
0 = no fatigue, 10 = worst imaginable
The free sandbox has every feature, with no credit card and no time limit. Build your forms, test the checks and show your team.
Kenyan research
Kenya has a long record of clinical and public-health research, with studies running through universities, national research institutes, hospitals and international collaborations, in areas such as infectious disease, maternal and child health, vaccines and non-communicable disease. Many studies run on grant funding with small data teams, which suits a self-serve platform with no setup fee and no per-site fee. See EDC for investigator-initiated trials and EDC for independent trial sites.
Where sites are spread across regions, the combination of site-level participant numbering, a separate site coordinator portal and exports by site keeps each centre separable. Moving from paper to electronic capture is a common first step, covered in paper CRF to eCRF conversion, and the AI study builder can draft forms from an uploaded protocol or form file for human review.
Before you start
Trial authorisation for medicinal products, and what applies to devices or non-drug studies.
Accredited committee identified; amendments and progress reports scheduled.
Research permit needs for your study type and for foreign investigators.
Safeguard or consent for data hosted in Frankfurt or N. Virginia, recorded in the contract and consent text.
How source is captured when a site has no connection, and who enters it.
Staff roles assigned and authenticator-app two-factor switched on.
The Pharmacy and Poisons Board authorises clinical trials of medicinal products. Ethics clearance and research permits are separate tracks, so confirm all three with your institution.
No. Capture hosts in the EU (Frankfurt) and the USA (N. Virginia). Under Kenya's Data Protection Act this is a transfer out of Kenya, so document the basis for it.
No. Capture is web based and needs a connection to enter data. Plan how sites with unreliable connectivity capture source records and enter them later.
No. Questionnaires are completed in a phone browser through a link, and sites can enrol participants with a QR code.
Yes. There are no setup or per-site fees, the sandbox is free with every feature, and you pay only when the study goes live.
Participant text is whatever your approved materials say. If you need to understand how a study will handle several languages, talk to us before you commit.
Keep exploring
BYOD ePRO, no app download
Questionnaires in the phone browser.
EDC for investigator-initiated trials
Academic sponsors.
Paper CRF to eCRF conversion
Moving off paper.
EDC for independent trial sites
Site-run studies.
eConsent software
Verified electronic signatures.
Clinical trial software in India
Another emerging research market.
Browser-based EDC, eCRF, ePRO and eConsent. Free sandbox, no credit card.