Africa is 54 countries, not one regulator. A multi-country study meets a different medicines authority, ethics system and data law in each. Capture keeps every site in one study with identical forms, site-level access and one audit trail, and you can build and test it free first.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Africa (multi-country)
Key points for studies in Africa
Regulation
For a medicinal product trial, each country normally has two or three separate conversations: the national medicines authority that authorises the trial and any import of investigational product, an ethics committee, and sometimes a research permit or council. In Nigeria that is NAFDAC and an NHREC-registered committee; in Kenya the Pharmacy and Poisons Board, an ethics committee and NACOSTI; in Egypt the Egyptian Drug Authority and a national ethics council. Country detail sits in the dedicated guides for Nigeria, Kenya and Egypt. Other authorities that sponsors commonly meet include SAHPRA in South Africa, the Food and Drugs Authority in Ghana and the National Drug Authority in Uganda, with UNCST on the research-governance side. Confirm each one directly, as roles and procedures change.
AVAREF matters when the same application goes to several African countries at once. Its joint review model brings assessors from several regulators and ethics committees into one coordinated review, and its harmonisation toolkit (application forms, assessment templates, joint review guidelines and GCP inspection tools) has been adopted by AVAREF members, with countries such as Ghana, Kenya, Zambia and Nigeria reported as early implementers. A joint review does not replace national approval; each country still issues its own decision. Ask your regulatory lead whether your product qualifies.
You will probably open countries at different times and receive different requests for changes to consent or participant information. Keep one protocol-level form set, activate sites as each approval lands and track consent versions per site. Capture locks approved forms for live use and keeps a field-level audit trail with timestamp, user, old value, new value and reason for change, so amendments are traceable. See multi-site clinical trial management and international multi-site trials.
Pre-launch readiness
1 site activated
1 form not yet approved
At a glance
A planning aid for the first conversation with each country. Confirm every row with the national authority and the ethics committee before you plan around it.
| Country | Trial authority | Data protection | Dedicated guide |
|---|---|---|---|
| Nigeria | NAFDAC; ethics committee registered with NHREC | Nigeria Data Protection Act 2023, NDPC | Nigeria page on this site |
| Kenya | Pharmacy and Poisons Board; ethics committee; NACOSTI | Data Protection Act 2019, ODPC | Kenya page on this site |
| Egypt | Egyptian Drug Authority; national ethics council | Personal Data Protection Law 151 of 2020 | Egypt page on this site |
| South Africa | SAHPRA; research ethics committees | POPIA (check current guidance) | Not covered separately |
| Ghana | Food and Drugs Authority; ethics committees | Data Protection Act (check current text) | Not covered separately |
| Uganda | National Drug Authority; UNCST and ethics committees (roles differ by source) | Data protection law (check current text) | Not covered separately |
General summary, not legal advice. Rows other than Nigeria, Kenya and Egypt were not verified in detail.
Connectivity
Capture runs in a browser and needs a connection to save data. It does not capture data offline. For African sites the practical answer is a study design that does not depend on the internet being available at the point of care: collect source on paper or in the clinic record, then enter it in Capture when a site has signal, with edit checks raising auto-queries at entry. Participants can answer questionnaires in a phone browser through a link with no app to install, but they need data coverage at that moment, so keep site-assisted completion as the fallback.
Evening diary
Question 3 of 8
How would you rate your fatigue today?
0 = no fatigue, 10 = worst imaginable
Build the forms, set the site roles and run a mock visit in the free sandbox. No credit card, no time limit.
Data protection
You do not need a different system per country, but you do need one consistent operating model: keep identifying data at the site, show sponsor-side users coded IDs, record where data is hosted and the legal basis for any transfer abroad, and make each consent say what happens to the data. In Capture, site coordinators see participant names while researchers see coded IDs, enforced by row-level security at the database layer, and data is encrypted with AES-256 at rest and TLS in transit.
Because hosting is in the EU or the USA, every African country in your study involves an international transfer. Several national laws, including those in Nigeria and Kenya, have a dedicated chapter on this, and some regulators expect a documented assessment or approval. Write the basis into your data sharing agreement and your participant information. For how the two best-known regimes compare, see HIPAA vs GDPR clinical trial data and GDPR compliant clinical trial software.
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.
Who uses it
Capture has no setup fee and no per-site fee, and the sandbox is free, so it suits teams that do not have an enterprise EDC budget or a service contract.
Investigator-led studies where the data manager is also the statistician. Build your own forms and run the study without a vendor project.
Read more Multi-countryA coordinating centre in one country and sites in several others, with site-level access and exports filtered by site.
Read more Paper to eCRFConvert existing paper CRFs into electronic forms and let the AI study builder draft them from your protocol or form file, for human review.
Read more Self-serveRun the data side yourself. You still carry sponsor duties and the national submissions.
Read moreBefore you start
Which countries open first, and whether a joint review route applies.
Run them in parallel and track in one plan.
Consent and participant information approved in the language each site uses; instrument licences held in your study file.
Written into contracts and consent text for each country.
Paper source plus delayed entry, and who is responsible.
Export it once for every national ethics package.
Site coordinator, researcher and admin accounts; authenticator-app 2FA for staff.
No. Each country has its own medicines authority and ethics process. Joint review routes such as AVAREF can coordinate assessment, but each country still decides for itself. Confirm current procedures with every authority.
No. Capture hosts in the EU (Frankfurt) and the USA (N. Virginia). Under several African data protection laws this is a transfer abroad, so document the basis for it in your contracts and consent text.
No. Capture is web based and needs a connection to enter data. Plan how each site captures source records when connectivity fails and who enters them later.
Yes. One study holds sites in many countries with site-level participant numbering, a separate site coordinator portal and exports filtered by site.
No. Questionnaires open in a phone browser through a link, and sites can enrol participants with a QR code. Participants do need data coverage when they answer.
Participant-facing 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.
Not to use Capture. The platform is self-serve, so a sponsor or university team can build, test and run a study. Sponsor obligations and national submissions remain yours.
Yes. The sandbox has every feature, with no credit card and no time limit. You pay only once you go live with real participants.
Keep exploring
Clinical trial software in Nigeria
NAFDAC, NHREC and the NDPA.
Clinical trial software in Kenya
PPB, ethics and the Data Protection Act.
Clinical trial software in Egypt
EDA and Law 151 of 2020.
International multi-site trials
Running sites across countries.
Multi-site clinical trial management
Site-level control in one study.
BYOD ePRO, no app download
Questionnaires in the phone browser.
Clinical trial software in India
Another large emerging market.
Self-serve EDC, eCRF and eConsent. Free sandbox, no credit card.