Egypt regulates trials through its own Clinical Trials Law, the Egyptian Drug Authority and a national ethics council, with a newer data protection law on top. Capture gives Egyptian sponsors, universities and investigators a cloud EDC they can build and test without local IT or a service contract.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Egypt
Key points for studies in Egypt
Regulation
Before Law 214 of 2020, trial oversight in Egypt was spread across several bodies. The law and its executive regulation gave the EDA a central role, including authorising trials, monitoring safety, inspecting sites and checking that sponsors have arranged participant safety and insurance measures. The EDA has published a guideline for good regulatory oversight of clinical trials, with versions updated as recently as March 2026, so download the current edition rather than relying on a summary.
Practically, expect a dossier to the EDA containing the protocol, investigator brochure, consent materials and participating site details, alongside ethics review. Sponsors outside Egypt commonly work through a local legal representative or a partner institution, and your regulatory lead should confirm what the EDA expects. This page cannot decide that for you. What the software can do is shorten the evidence loop: Capture exports a blank eCRF PDF with a cover page, form index and visit-by-form matrix for the submission package, and keeps a field-level audit trail that can answer an inspector's questions later.
The EDA's GCP guideline is described as applying to interventional medical research on human subjects. Observational, registry and academic questionnaire studies may follow lighter routes, but they usually still need ethics approval. Ask the committee and the EDA which route applies before you build the schedule.
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
Egypt's Personal Data Protection Law 151 of 2020 sets out data subject rights, controller and processor duties and a supervisory authority, the Personal Data Protection Center. Its application was held back until executive regulations arrived. Secondary sources report that these were issued in December 2025 and that regulated entities have until around 31 October 2026 to comply, with attention on licences, cross-border transfers and appointing a data protection officer. Sources disagree on regulation numbers and details, so rely on the official text.
For a trial, the questions are familiar. What is the legal basis for processing health data, can the sponsor work with pseudonymised data, and what is the basis for transferring data outside Egypt? Capture hosts in the EU (Frankfurt) or the USA (N. Virginia). Hosting there is a transfer abroad, so state it in the data sharing agreement and participant information, and ask counsel whether a licence or permission is needed. Within Capture, site coordinators see participant names, researchers see coded IDs, and row-level security enforces the split in the database. Compare the logic with 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.
Consent
Capture eConsent collects the participant's on-screen signature, verified with a one-time email code, then the investigator countersigns with password re-authentication. Each signature is hashed to the exact document content at signing, and the signed consent exports as a PDF with signature data, timestamps and audit trail. Consent text is whatever your approved Arabic or English materials say. Confirm with the ethics council whether electronic consent is acceptable for your study type before you rely on it.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
Build forms, run a mock visit and sign a test consent in the free sandbox. Go live only when the authority and the ethics bodies have cleared the study.
Typical start-up
A sketch for planning, not a regulatory timeline. Confirm every step with the EDA and your ethics committee.
Decide whether the study is interventional, observational or a device or diagnostic study, and ask the EDA and committee what applies.
Protocol, investigator brochure, Arabic and English consent materials, insurance evidence and the blank eCRF PDF exported from Capture.
Site committee review and the national ethics council step, as the EDA guideline describes. Track amendments as versions.
Authorisation of the trial and any import of investigational product. Do not enrol before it arrives.
Create site accounts, train staff and open enrolment site by site. Participant numbers are assigned per site, for example 001-0042.
Egyptian research
Egypt has a large patient population, major university hospitals and a growing base of investigators, which makes it a frequent addition to Middle East and North Africa programmes as well as a home for locally sponsored academic studies. Teams without an enterprise EDC budget can use Capture without a setup fee or a per-site fee; the sandbox is free. See EDC for investigator-initiated trials and research data capture for academic studies.
If Egypt is one country in a wider African programme, the regional picture, including joint review routes, is in clinical trial software for Africa. Teams comparing with another large market in the region can also read the Nigeria guide, which has a different regulator and data law.
Before you start
Interventional, observational or device route, plus phase conditions for your product origin.
Site committees and the national ethics council, with amendment and report schedules.
Consent, participant information and questionnaire text; instrument licences held in your study file.
Legal basis, pseudonymisation, transfer basis and any licence for data hosted in Frankfurt or N. Virginia.
How source is captured when a site loses connection, and who enters it.
Site coordinator, researcher and admin accounts with authenticator-app two-factor sign-in.
The Egyptian Drug Authority (EDA) authorises trials of investigational drugs and biologics under Clinical Trials Law 214 of 2020. Ethics review runs alongside and includes a national council step. Confirm the current process with the EDA.
Personal Data Protection Law 151 of 2020, with executive regulations reported as issued in December 2025. Check the official text and the compliance date, which sources cite as around 31 October 2026.
No. Capture hosts in the EU (Frankfurt) and the USA (N. Virginia). Treat this as a transfer abroad, document the basis and ask counsel whether any permission is required.
No. Capture is web based and needs a connection to enter data. Plan how sites capture source records when connectivity fails.
No regulator approves or certifies EDC software the way it approves a study. Capture provides controls such as an audit trail and e-signatures; your own validated use and submissions are what the EDA reviews.
Participant text is whatever your approved materials say. If you need to understand how a study will handle Arabic and English side by side, talk to us before you commit.
Yes. The free sandbox has every feature with no credit card and no time limit.
Keep exploring
Clinical trial software for Africa
The continental picture.
Clinical trial software in Nigeria
A different regulator and data law.
Clinical trial software in Kenya
East Africa.
eConsent software
Verified electronic signatures.
GDPR compliant trial software
Principles shared by many laws.
EDC for investigator-initiated trials
Academic sponsors.
Self-serve EDC, eCRF and eConsent. Free sandbox, no credit card.