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In 2021, technology platforms play a major role in supporting clinical trials, making it possible for documentation to be tracked and submitted securely online and for any concerned parties to quickly access the latter.
As a French medical translator, I have frequently seen references to one such platform used by the CNRIPH (Commission Nationale des Recherches Impliquant La Personne Humaine [National Committee for Trials Involving Human Subjects]) called the SI-CNRIPH, with SI standing for information system. However, in recent months, I noticed a shift to SI-RIPH2G. I wondered what the 2G stood for and what it was modifying in this acronym.
Well, I was pleased to find a manual for France’s information system and a French ethics committee website that gave me some answers.
SI-RIPH2G means Système d'Information des Recherches Impliquant la Personne Humaine 2ème Génération, [2nd-generation information system for research involving human subjects]). I learned that the 2nd generation modifies the IS, because this is an IS replacing the SI-CNRIPH. According to the CPP SUD MED 2 website, the shift to the 2G IS took place as of May 26, 2021. Now, the old IS is only available for viewing purposes, and all submissions will now be made on the new system.
I also learned that, in this SI-RIPH2G, the sponsor can submit documentation related to their research, a CPP is assigned and can communicate with the sponsor, and opinion/request notifications can be accessed easily. This supports the correct application of European law and the creation of a robust information system on clinical trials in France.
Hopefully, this short post has piqued your interest to better understand the clinical trial process in France or even in the USA. I have translated for this field for 6 years, and I’m always learning new facts, which keeps me on my toes and always coming back for more.