CTIS is the single portal through which sponsors apply for, update and close out clinical trials in the EU. It does not collect your trial data, but it asks what your data system will do. This guide explains the portal, the dossier and the readiness work around it.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Sponsor prepares the dossier
Part I (scientific) and Part II (national)
Submission in CTIS
One application for all member states concerned
Validation and assessment
Requests for information answered in the portal
Decision per member state
Authorisation, with conditions where set
Conduct, modifications, safety reports
Updates go through the same portal
End of trial and results
Notification, summary of results, layperson summary
CTIS in one page
The portal
CTIS, the Clinical Trials Information System, is the EU single-entry point for submitting clinical trial information. It is run by the European Medicines Agency together with the member states and the European Commission, and it supports sponsors and authorities across the whole life of a trial. It replaced the older national submission routes under the Clinical Trials Directive. Trials authorised under that Directive and still running beyond 30 January 2025 had to be transitioned into CTIS, so for practical purposes any medicinal product trial with EU sites now lives in this system. Check the current EMA pages for the exact transition rules that apply to your trial.
Three groups use it. Sponsors, or the CROs and regulatory teams acting for them, prepare and submit applications and keep the trial record current. Member state authorities and ethics committees assess and decide. The public sees a transparency view of much of the trial information, which is why the content you upload has to be written with publication in mind. If you are working in a specific country, the national flavour of the same process is covered on our pages for Denmark, Sweden, France and Germany.
If you are deciding what the regulation itself changed and where your software fits, start with our EU Clinical Trials Regulation guide. This page goes one level down: the portal, the dossier and the preparation.
The dossier
An initial application is split so that the parts that are the same everywhere are assessed together, and the parts that depend on national law are assessed locally. In general terms, Part I carries the scientific and safety substance: the protocol, the investigator brochure, the investigational medicinal product dossier and the documents about the product and its manufacture. Part II carries the national and participant-facing content: informed consent materials, recruitment and advertising, subject compensation, suitability of the investigator and the sites, and data protection information.
The exact document list and which authority assesses which section vary by country and by trial type, so treat any summary, including this one, as orientation and open the EMA sponsor handbook for the current list. What matters for your data system is how many of those documents describe it indirectly. The protocol defines the visits and the data. The consent form states what is collected and who sees it. The site suitability documents describe where data is entered. Each is a promise your system must keep.
Whatever the protocol says about visits, assessments and windows is what your case report forms and schedule must reproduce. A clean way to avoid mismatches is to build from the approved protocol and keep the build in step with every amendment. Our guide to protocol amendments without change orders and the note on eCRF versioning for mid-study changes explain how to do that without losing history.
Part II content is judged by the ethics side of the review, and the version approved is the version participants must see. If you use electronic consent, keep the approved text and the system record aligned, and read eConsent software for clinical trials for what to check.
After submission
A summary of the stages the EMA sponsor handbook describes. Timelines and wording are set by the regulation and the EMA evaluation-timelines document, so they are deliberately not copied here.
| Stage | What happens in the portal | What your data system should be ready for |
|---|---|---|
| Initial application | Sponsor submits the dossier; the application is validated and then assessed. Requests for information are answered in the portal. | A study build that matches the draft protocol, plus a test environment assessors and auditors can be told about. |
| Decision | Each member state concerned decides on the trial; for multinational trials the assessment of Part I is shared, with an individual national decision. | Only approved forms and consent versions go live, per country if versions differ. |
| Substantial modification | Changes affecting safety, rights or data reliability are submitted, assessed and decided before they are implemented. | Amend forms and schedule with a trail of who changed what, when and why. |
| Notifications and safety reporting | Start, recruitment status, temporary halt and serious breaches are notified; safety reports are submitted. | Dates, counts and safety data you can pull quickly and trust. |
| End of trial | The sponsor notifies the end of the trial in the portal. | A defined last-visit and data-cleaning plan, so the date you notify is real. |
| Results | Summary of results, layperson summary and, where required, the clinical study report are submitted. The summary is generally due within 12 months of the end of the trial, but confirm the deadline in Article 37 and the sponsor handbook. | A locked, reproducible dataset and exports with a data dictionary. |
Orientation only. Open the current regulation and the EMA documents before you plan dates.
Draft the visits and forms from your protocol and test skip logic, edit checks and the audit trail in the free sandbox before you submit anything.
Readiness
CTIS does not validate your EDC. It does, however, set expectations that your data system then has to meet, and inspectors compare the two. The EMA guideline on computerised systems and electronic data in clinical trials is the reference for what an inspector expects of the system, covering audit trails, access control, validation and archiving. Our EMA computerised systems guideline guide summarises it, and Annex 11 versus 21 CFR Part 11 compares the EU and US rules.
Readiness is easier when it is concrete. Decide where the data will be hosted and say so in your data protection documents. Capture can host in the EU (Frankfurt) or the USA (N. Virginia), chosen per study. Make sure the people who will access data are in the right roles. Agree who will build, test and release changes, and how you will show the approved version of every form. Then rehearse the end: an export with a data dictionary, an audit trail export and a plan for lock, covered in our database lock checklist.
Capture provides 21 CFR Part 11-aligned controls: a field-level audit trail with timestamp, user, old value, new value and reason for change; role-based access; electronic signatures with re-authentication on countersignature; and a draft to approved form lifecycle where approved forms are locked for live use. It also exports a blank eCRF PDF with a cover page, form index and visit-by-form matrix that can support your documentation. Capture does not submit to CTIS for you and does not replace your regulatory team: the application, the dossier and the portal workflow stay with the sponsor.
Checklist
Use this alongside, not instead of, the EMA sponsor handbook.
Build visits and forms from the draft protocol and review every field against it before submission.
One approved version per country and language, with a record of who consented to which version.
State the hosting region and the roles that can see identifiable data.
Run a test record through entry, change, query and signature in the sandbox and export the trail.
Know how a change to forms is requested, tested, approved and released, and who signs.
Define last visit, cleaning, lock and the exports that feed the results summary.
In Capture
Assessment time is build and test time. Upload the protocol and let the AI study builder draft the visit schedule and forms, then review every item yourself, since nothing is saved without human review. Test edit checks, skip logic and e-signatures with sample data, and export the blank eCRF PDF for your files.
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.
CTIS is the Clinical Trials Information System, the EU single-entry portal for submitting and managing clinical trial applications and information under Regulation (EU) No 536/2014. Sponsors and authorities use it throughout the lifecycle of a trial.
No. CTIS holds the dossier, decisions, notifications and public information. Participant-level data stays in your own data capture system, which must be consistent with what you submitted.
In general terms Part I covers the scientific and safety content assessed jointly by the member states concerned, and Part II covers national aspects such as consent, recruitment and site suitability. Check the EMA sponsor handbook for the exact document lists.
Trials authorised under the old Directive that were foreseen to continue beyond 30 January 2025 had to be transitioned to CTIS. Check the current EMA guidance for your trial.
A summary of results is generally due within 12 months of the end of the trial, with layperson summary and clinical study report requirements alongside. Confirm the deadline in the regulation and the sponsor handbook for your case.
No. The submission is made by the sponsor or its representative in the portal. Capture supports the data side: study build, audit trail, e-signatures, role-based access, EU hosting in Frankfurt and exports.
Capture provides 21 CFR Part 11-aligned controls. Compliance is a shared responsibility with your own validated use, so keep your validation file and test your build in the sandbox first.
No. Use it as orientation and check the current regulation, the EMA documents and your national authority before acting.
Keep exploring
EU CTR guide
What the regulation changed.
EMA computerised systems guideline
What inspectors expect.
Annex 11 vs 21 CFR Part 11
EU and US rules compared.
Clinical trial software in Germany
National picture.
Clinical trial software in Sweden
Parallel review in practice.
Protocol amendments without change orders
Amend safely.
Database lock checklist
Prepare for the end.
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