Nigerian trials need NAFDAC authorisation, an ethics committee registered with NHREC and a data plan that fits the Nigeria Data Protection Act 2023. Capture gives sponsors, universities and teaching hospitals a self-serve EDC they can build and test free.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Nigeria
Key points for studies in Nigeria
Regulation
A Nigerian drug trial has a regulator track and an ethics track. For NAFDAC, the application form is accompanied by the protocol, the informed consent form and the participant information leaflet, plus evidence that the ethics committee is accredited by NHREC, the committee's approval from participating centres and the meeting minutes. The investigator's brochure and product quality data are also reviewed. The NHREC-registered committee, usually based at a university or teaching hospital, issues the ethical opinion that NAFDAC waits for before final authorisation. NHREC also runs the Nigeria Clinical Trials Registry, and registration of a trial there is commonly expected, so ask your committee.
NAFDAC's guideline still refers applicants to its Good Clinical Practice guidelines, and one practitioner source says an updated GCP framework aligned to ICH E6(R3) applied from May 2025. We could not confirm that from NAFDAC itself, so check the current GCP document on the NAFDAC website. Either way, the consequence for your data system is the same: an audit trail, controlled forms and reliable consent records. See good clinical practice.
Behavioural, questionnaire, registry and many diagnostic studies are not authorised by NAFDAC in the same way. They still need NHREC-registered ethics review, and NAFDAC may need to be consulted for devices or products. Ask the committee at the start which route applies.
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 NDPA lists health-related data as sensitive personal data, which needs a lawful basis such as explicit consent and stronger safeguards. Section 28 requires a DPIA where processing is likely to pose a high risk, and the controller may have to consult the Commission. Part VIII covers transfers outside Nigeria: the Commission looks at adequacy, and the Act lists other bases such as contractual clauses and binding corporate rules. Secondary summaries simplify this, so use the statute and your counsel. The research provisions are not covered by this page, because the search sources we used did not set out their conditions.
A defensible set-up for an international trial usually combines pseudonymised data for the sponsor, a contract recording the transfer basis and consent text telling participants that their coded data is hosted outside Nigeria. In Capture, site coordinators see participant names, researchers see coded IDs, and row-level security in the database enforces it. Data is encrypted with AES-256 at rest and TLS in transit; you choose Frankfurt or N. Virginia at study setup, and neither is in Nigeria. See also GDPR compliant clinical trial software for the principles Nigerian law partly resembles.
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.
Multi-centre
NAFDAC asks for ethics approval from each participating centre, so a multi-site Nigerian study accumulates approvals at different times. Create sites in Capture as they are cleared. Participants are numbered by site, site coordinators work in their own portal and see only their own participants, and sponsor-side users can filter dashboards and exports by site.
Study owner
Builds and configures the study
Principal investigator
Oversees the site, signs off the casebook
Sub-investigator
Enters and signs clinical data
Study coordinator
Screens subjects, enters visit data
Monitor (CRA)
Verifies data, raises queries
Data manager
Reviews, freezes and locks data
Participant
Completes their own questionnaires
Build the forms, test the checks and rehearse a visit in the free sandbox. No credit card, no time limit.
Practicalities
Capture is web based and has no offline mode. Planning for connectivity is part of your study design, and these patterns are common.
Capture source in the clinic record or on paper at the visit. Enter it in Capture when the site has a connection. Edit checks raise an auto-query as each value is saved.
Read moreGive each site a coordinator responsible for entry and timeliness. Role-based access keeps everyone else away from names and unrelated sites.
Participants answer in the phone browser through a link, with no app to install. They need data coverage at that moment, so keep site-assisted completion available.
Read more RemoteWhere visits are far apart, consider remote data collection for questionnaires and consent steps, within what your ethics committee approves.
Read moreNigerian research
Nigeria hosts studies run through university teaching hospitals, research institutes and international collaborations, in areas such as infectious disease, maternal and child health, sickle cell disease and non-communicable disease. Many projects run on grant funding with small data teams, which suits a platform with no setup fee, no per-site fee and a free sandbox. See EDC for investigator-initiated trials and research data capture for academic studies.
Nigeria also sits inside wider West African and pan-African programmes. For the regional picture, including joint review routes, see clinical trial software for Africa. For a neighbouring regulator with a different structure, compare Kenya.
Before you start
Approvals for each participating centre and meeting minutes ready for NAFDAC.
Form, protocol, consent form, participant information leaflet and product data, using the current guideline.
Ask the committee whether registration in the Nigeria Clinical Trials Registry applies.
Lawful basis, section 28 DPIA if high risk, transfer basis for EU or US hosting.
Paper source plus delayed entry, and who is responsible.
Site coordinator, researcher and admin accounts with authenticator-app two-factor sign-in.
NAFDAC authorises clinical trials of medicinal products. A health research ethics committee registered with NHREC must give an opinion first. Confirm the current guideline version on the NAFDAC website.
Both are commonly needed for a drug trial: NAFDAC for the trial itself and a NHREC-registered ethics committee for the ethical opinion. NAFDAC issues final authorisation only after the ethical opinion is in.
The Nigeria Data Protection Act 2023, supervised by the NDPC. Health data is sensitive, and the Act has rules on transfers abroad. Ask counsel how its research provisions apply to your study.
No. Capture hosts in the EU (Frankfurt) and the USA (N. Virginia). Hosting there is a transfer outside Nigeria, so document the basis in your contract and consent text.
No. Capture is web based and needs a connection to enter data. Plan how sites capture source records when connectivity fails and who enters them later.
No regulator approves or certifies EDC software the way NAFDAC authorises a trial. Capture provides controls such as an audit trail and e-signatures; your validated use and submissions are 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 for Africa
The continental picture.
Clinical trial software in Kenya
PPB and the Data Protection Act.
Clinical trial software in Egypt
EDA and Law 151 of 2020.
Multi-site clinical trial management
Site-level control.
Paper CRF to eCRF conversion
Moving off paper.
GDPR compliant trial software
Principles shared by many laws.
Self-serve EDC, eCRF and eConsent. Free sandbox, no credit card.