France has large academic hospital networks and a well-defined framework for research involving people, with specific data protection rules. Capture runs French sites in the same study as the rest of your programme, hosted in the EU.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
France
Key points for studies in France
Research landscape
In France, the regulatory and data protection sides of a study are closely linked. The research category under the Jardé law determines the ethics and authority steps; the data protection route depends on whether the study fits a CNIL reference methodology or needs a specific authorisation. Planning both at protocol stage avoids surprises during start-up.
Whatever the route, the study database should collect only what the protocol needs, keep identifying information separate from study data, and record who accessed and changed what. Capture shows sponsor-side users coded participant IDs, keeps names at the site, and records every change in a field-level audit trail. See GDPR compliant clinical trial software.
French rules on hosting personal health data for third parties can require the host to hold HDS certification. Whether they apply depends on your study set-up and who hosts what. Ask each vendor about it during selection, and document the conclusion with your data protection officer.
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.
Controls
Approved forms are locked and identical at every site, edit checks raise queries at entry, electronic signatures require re-authentication, and the audit trail is append-only. French sites see only their own participants, and sponsor-side users see coded IDs.
Weight changed 68.0 to 68.5 kg
Site coordinator · Reason: Transcription error
Query Q-0014 answered on Weight
Site coordinator · Reason: Source checked
Vital signs form locked
Data manager · Reason: Visit cleaned
Build the study in the free sandbox and export the blank casebook PDF.
Jardé law
| Category | Scope | Typical approvals |
|---|---|---|
| RIPH 1 | Interventional research not justified by usual care | CPP opinion and ANSM authorisation |
| RIPH 2 | Interventional research with minimal risks and constraints | CPP opinion; ANSM informed |
| RIPH 3 | Non-interventional research | CPP opinion |
Clinical trials of medicinal products follow the EU Clinical Trials Regulation. Check current requirements for your study type.
Academic research
Public university hospitals sponsor a large share of French clinical research, often funded through national programmes such as the hospital clinical research programme (PHRC). Hospital sponsors typically have research departments that manage regulatory submissions, data protection and monitoring for their investigators.
For those teams, a self-serve system that investigators can build and test before submission, with blank eCRF PDFs for the CPP and no per-site fee as other hospitals join, fits the way academic trials are run. See clinical trial software for European universities.
Before you start
EU CTR trial or Jardé category confirmed.
Submissions planned for the category.
Reference methodology or specific authorisation.
Health data hosting rules assessed with vendors.
Approved consent and participant documents.
Ethics approval, contract, initiation visit and delegation log.
Public university hospitals sponsor many trials, often funded by national programmes.
Yes. The blank eCRF PDF includes every approved form.
The ANSM is the national competent authority, and CPPs (ethics committees) review the ethical aspects.
The French framework for research involving people, which defines three categories of research with different approval requirements.
A CNIL reference methodology for health research. Studies that meet its conditions can follow a simplified data protection route.
They can, depending on who hosts personal health data for whom. Assess them with your data protection officer and ask each vendor.
Capture hosts study data in the EU (Frankfurt) or the US (N. Virginia), chosen at study setup, with AES-256 encryption at rest and TLS in transit. Choosing Frankfurt keeps study data in the EU.
Yes. The free sandbox has every feature with no credit card and no time limit.
Keep exploring