A RIPH / CNIL checklist generated from your study
Proposed classification, identified ethics committee / ANSM / CNIL formalities, exportable traceability document: regulatory qualification done early, not the night before submission.
How it works
Three entry points, one defensible qualification
- 1
Study characteristics
From a Protocolis synopsis or an uploaded external document, the module identifies the nature of the research, the population and the intervention.
- 2
Loi Jardé decision tree
The AI applies the RIPH 1 / 2 / 3 / non-interventional logic and lists the related formalities: ethics committee opinion, ANSM authorisation, CNIL reference methodology.
- 3
Checklist + Word annex
You get an actionable checklist and an exportable traceability document, ready to attach to the protocol or to the ethics committee dossier.
What you get
Regulation framed early, not at the end
Justified classification
For each study, the proposed classification comes with the reasoning and the supporting articles (Loi Jardé, public health code).
Ethics committee / ANSM / CNIL formalities
List of expected steps based on the classification: ethics committee opinion, ANSM authorisation, MR-001 to MR-006, CNIL declaration if needed.
Annex to the protocol
Reusable .docx traceability document as a regulatory annex to the protocol — useful for internal research office reviews and ethics submissions.
Standalone endpoint
You can also qualify an external synopsis without going through the full design: upload the document, classification returned.
Frequently asked questions
What you should know about qualification
Is the returned classification binding for the ethics committee?
No. The classification returned is a reasoned proposal to frame your file; the ethics committee, and ultimately the sponsor, validate the final qualification. The goal is to avoid back-and-forth.
Can I qualify a study without having drafted the synopsis on Protocolis?
Yes. The module accepts an external document (Word or PDF synopsis) and returns a standalone qualification. Typical use case: a research office receives an in-flight dossier and wants a quick framing.
Does the module cover non-interventional research on data?
Yes. The non-interventional branch is handled, with reminders of the relevant CNIL reference methodologies (MR-004 in particular) and their application conditions — useful for retrospective studies.
Is it included in every plan?
The module is included by default in DRCI licences (Essential and Premium). On the Team licence, it ships as a 30-day trial so you can evaluate its value before subscribing.
Qualify your study before it gets blocked
Trigger qualification from your Protocolis synopsis or upload an external document — the regulatory checklist is delivered in minutes.