Israeli trials combine Ministry of Health approval, Helsinki committee review and a privacy law whose Amendment 13 tightened rules on health data in 2025. Capture is a self-serve EDC with EU or US hosting that sponsors and startups can build free.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Israel
Key points for studies in Israel
Regulation
In Israel the MoH regulates clinical trials of medicines and devices, and each trial site has a Helsinki committee that reviews ethics, which is the Israeli term for the ethics committee under the Declaration of Helsinki. Commentary describes a registration requirement on the MoH MyTrial site and a national committee that evaluates multi-centre trials under a 2023 guideline. We could only confirm these through secondary law-firm material, so read the MoH pages and ask your CRO or site office for the current steps.
Whoever reviews your protocol, they will ask what is collected and how identity is separated from analysis. Capture exports a blank eCRF PDF (cover page, form index, visit-by-form matrix and every approved form empty) and keeps a field-level audit trail with timestamp, user, old value, new value and reason. See how to get IRB approval and good clinical practice.
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
Summaries of Amendment 13 agree on the main points: a broader definition of personal data that includes health information, a category of especially sensitive data that includes genetic data, enhanced enforcement powers for the Privacy Protection Authority, and obligations for some organisations to appoint a data protection officer or register databases. Which of those apply to a sponsor, a CRO or a hospital in a given trial is a legal question. We found no source on how Amendment 13 interacts with Helsinki committee approval, so do not assume one answers the other.
Tell participants clearly where data is stored. Capture hosts in Frankfurt and N. Virginia, so Israeli data is processed abroad, and consent should say that. If a site or the MoH requires that data stay in Israel, Capture should not be assumed to fit. To limit exposure, use the role split: site coordinators see names, researchers see coded IDs, enforced by row-level security. AES-256 protects data at rest and TLS in transit. Compare regimes in HIPAA vs GDPR clinical trial data.
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.
Set up coordinator and researcher roles in the free sandbox and screenshot the views for your privacy officer.
Due diligence
| Question | Why it matters | What Capture can offer |
|---|---|---|
| Is the study in scope of a Helsinki committee? | Scope disputes show it is not always obvious for data-only work. | Forms, consent and exports that match what the protocol says. |
| Does the MoH need registration on MyTrial? | A start-up step reported in a legal guide. | Protocol fields reused when registering. |
| Can data be processed outside Israel? | Determines whether EU or US hosting is acceptable. | Frankfurt or N. Virginia only; state it in the consent. |
| Does Amendment 13 trigger a DPO or database registration? | Depends on organisation and volume. | Role matrix and audit trail to support your documentation. |
| Is genetic or biometric data collected? | Treated as especially sensitive. | Keep it out of the eCRF unless counsel has cleared it. |
Capture is not a legal adviser. Confirm each row with Israeli counsel.
Digital health studies
Israel has a large digital health and medtech sector, and many studies combine a device with participant-reported outcomes. Capture supports native OAuth sync for configured devices, where the participant connects their own account and data flows into the study with last-sync time, sync-now and disconnect controls. Which devices are configured is set per deployment, so ask before assuming a specific device. Pair this with eConsent and a clear data flow statement.
Research landscape
Israeli research is concentrated in the large medical centres around Tel Aviv, Jerusalem, Haifa and Beer Sheva, backed by a dense startup scene in digital health, medtech and oncology. Startups often run first-in-human or pilot work at one or two sites, then extend to Europe or the US. A single platform that moves from a pilot to Phase 2 or 3 is useful: see clinical trial software for medtech startups and EDC for Phase 3 clinical trials.
For multi-country data, site-level participant numbering and by-site exports keep each country's data apart, as set out in multi-site clinical trial management. Nearby markets include Turkey, Egypt and Saudi Arabia, and a mature EU example is the Netherlands.
Typical start-up
A planning sketch, not a regulatory timeline.
Decide if it is a clinical trial, a device study or data-only research, and which committee applies.
Get advice on Amendment 13 duties and on processing abroad.
Build forms, consent and diaries and test with the site team.
MoH registration and Helsinki committee submission, with the blank eCRF PDF attached.
Create site accounts after approvals and enrol participants.
The Ministry of Health and a Helsinki committee at the site, with a national committee for multi-centre trials according to one 2025 legal guide. Confirm the current process with the MoH or your CRO.
No. Capture is hosted in the EU (Frankfurt) and the USA (N. Virginia). If your study must keep data in Israel, get legal advice and do not assume Capture fits.
An amendment to the Privacy Protection Law reported to have taken effect on 14 August 2025. Summaries say it broadens personal data, treats health and genetic data as especially sensitive and adds duties for some organisations. Ask counsel how it applies to you.
No. Capture is self-serve with no office, partner or CRO in Israel.
No regulator approves EDC software that way. Capture gives you an audit trail, e-signatures and access controls, and your validated use is assessed.
This page does not claim multilingual or right-to-left support. Ask us about current language options before planning around them.
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 in the Netherlands
WMO, METC and CCMO.
Clinical trial software in Turkey
TITCK and KVKK.
Clinical trial software in Egypt
Regional market.
Clinical trial software for medtech startups
From pilot to pivotal.
HIPAA vs GDPR clinical trial data
How regimes compare.
Pricing
Free sandbox, pay at go-live.
Build, test and share the role views with your privacy officer for free. Pay only at go-live.