A Horizon Europe consortium needs one data system that many partners can use from day one, with the data management plan already in mind. Capture gives each partner site its own access, hosts study data in the EU (Frankfurt) and keeps one audit trail across forms, diaries and consent. Build and test it free before the work package starts.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Partner sites with access
4 of 5
Forms approved
12 of 14
What a Horizon Europe clinical work package needs from its data system
The consortium reality
A Horizon Europe project is usually a consortium: a coordinator, several beneficiaries, sometimes associated partners, all bound by a grant agreement and a consortium agreement. Clinical data is rarely the only deliverable. It sits inside a work package with milestones, a periodic reporting cycle and a budget that was fixed when the proposal was written. Nobody on the clinical side has a procurement department with six months to run a vendor selection, and the IT support at partner institutions varies widely.
That shapes the shortlist. The system must be usable by a partner site coordinator with an afternoon of training, must not require each partner to install or validate anything locally, and must be testable before the first participant is screened. A free sandbox with every feature lets the work package lead build the case report forms, invite two partners to rehearse, and write the data section of the plan from what actually exists rather than from a vendor brochure.
The project also has a life after the grant. Data may need to be preserved, shared in a controlled way or deposited in a repository once it is coded and anonymised as far as the consent and the law allow. Those decisions belong to the consortium, but the tool should not make them harder. Exports in CSV or Excel with an automatic data dictionary, and SDTM datasets as SAS XPT files with Define-XML, give a statistician and a repository something structured to work with.
Capture is not approved, endorsed or certified by the European Commission or any funding body, and no such approval exists for a data capture tool. Whether software or hosting is an eligible cost, and how it is budgeted, depends on the call and the funding model, so ask your project office or national contact point. The EDC budget line item for grant proposals page lists what to write down about a data system when you cost it.
Partner access
Site coordinators at each partner see their own participants and enter data in the approved forms. Researchers and statisticians see coded IDs, not names, and exports can be filtered by site. Roles are the way the consortium agreement is reflected in the system.
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
Data management plan
Funder templates differ, so use this as a map of what the tool can show you, then write the plan in your own words. The data management plan template gives a document skeleton.
| Typical DMP question | What to describe | Where it lives in Capture |
|---|---|---|
| What data will be collected? | Variables, units, visit schedule | Approved forms and the automatic data dictionary |
| How is quality assured? | Validation at entry, query handling | Edit checks with auto-queries, calculated fields, source data verification set per field |
| Who can access what? | Roles by partner and function | Researcher, site coordinator and admin roles; PII segregation |
| Where is it stored? | Hosting region and security | EU (Frankfurt) or USA (N. Virginia), AES-256 at rest, TLS in transit |
| How is change traced? | Audit trail and signatures | Field-level audit trail with old and new value and reason; e-signatures |
| How is it shared or preserved? | Formats and documentation | CSV/Excel with data dictionary; SDTM as SAS XPT with Define-XML |
| How is personal data protected? | Pseudonymisation, minimisation | Coded IDs for researchers; configurable forms so you collect only what you need |
Capture provides GDPR-ready infrastructure and 21 CFR Part 11-aligned controls. Your sponsor responsibilities, consortium agreement and data protection impact assessment remain yours. This is not legal advice.
Build one study in the sandbox, invite a partner, and attach a real data dictionary to the draft plan. Free, every feature, no credit card.
Regulation and ethics
Horizon Europe money does not replace regulatory approval. If the project tests a medicinal product, the EU Clinical Trials Regulation and the national ethics review apply as for any trial, and the sponsor role has to be assigned to a real legal entity in the consortium. The EU CTR guide explains how an EDC fits into that picture, and the EMA computerised systems guideline lists the data-system expectations that sponsors, academic or not, are asked to meet.
For observational, device or behavioural work packages the regulatory route differs, but the data principles are the same: informed consent that matches what you do with the data, access limited by role, changes traceable, and a way to show an auditor or reviewer what happened. GDPR compliant clinical trial software and the DPIA template cover the data-protection side, and European universities describes the sponsor view of a single academic institution.
Plan for the participation of partners outside the EU separately. Who counts as an associated or third-country participant, and what that means for data transfers and eligibility, changes over time. Take that question to your project office and data protection officer, not to a software vendor.
Rollout
One person in the consortium owns the forms, roles and data dictionary. Without a named owner, partners drift into local variations.
Upload the protocol and let the AI propose the visit schedule and forms, then review every field with the clinical leads. Nothing is saved without human review.
Invite one hospital and one university into the sandbox, enter test participants and trigger edit-check queries so everyone sees the same workflow.
National ethics committees approve their own consent text. Build the eConsent versions you need and keep the approvals with your project records.
Approve the forms, invite site coordinators, enroll, and export with the data dictionary for each reporting period. Paid plans apply from go-live; see pricing.
Before you commit
Hosting region, roles, audit trail and export formats are described from what you tested.
The consortium agreement states who decides purposes and means; the vendor agreement states processing terms.
A coordinator can be invited and trained without installing software.
A full export with the data dictionary opens in your statistician’s software.
Participants are told about any controlled sharing or deposit of coded data.
No. No funder approves a data capture tool. This page describes practical fit: EU hosting, role-based partner access, an audit trail and structured exports. What the grant requires is set by your call, grant agreement and project office.
Yes. Partner sites share one study with the same approved forms, separate site coordinator access, site-level participant numbering and by-site exports.
It gives you facts to write down: an automatic data dictionary, hosting region, roles, audit trail and export formats. The plan itself, and any funder template, is yours to complete.
You choose EU (Frankfurt) or USA (N. Virginia) at study setup. For most Horizon Europe projects the EU region is the natural choice.
Capture exports CSV/Excel with a data dictionary and SDTM datasets as SAS XPT with Define-XML. Whether and how coded data is shared is a consortium and consent decision.
The sandbox is free with every feature and paid plans apply once you go live with real participants. Check the pricing page, and confirm with your project office whether and how it is an eligible cost.
Keep exploring
Clinical trial software for European universities
The single-institution academic sponsor view.
EU CTR and clinical trial software
How an EDC fits the Clinical Trials Regulation.
GDPR compliant clinical trial software
Pseudonymisation and EU hosting.
Multi-site clinical trial management
Sites, numbering and exports.
Data management plan template
A skeleton for the data section.
Clinical research software for universities
Research-office requirements.
Free sandbox with every feature. No credit card, and you pay only when you go live with real participants.