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Resources on academic clinical research
In-depth articles written by the Protocolis team, drawing on our hands-on experience in academic clinical research. Methodology, regulation, funding — the fundamentals for structuring your projects.
Investigator and DRCI: roles, responsibilities and friction points
The investigator ↔ DRCI relationship is at the heart of every academic clinical study — and the most common source of delays. A map of the roles, the distinction between investigator-side and sponsor-side CRAs, 5 recurring friction points and best practices to smooth collaboration.
The Protocolis team9 min read
Information sheet and informed consent in clinical research
The information sheet and the informed consent form (ICF) are among the documents most often sent back for revision by ethics committees (CPP). Distinguishing the two documents, the expected structure, adaptations by RIPH category and drafting mistakes to avoid.
The Protocolis team7 min read
PHRC, PREPS, PHRIP, PRME: clinical research funding calls
Understanding PHRC, PREPS, PHRIP, PRME, RHU, FHU, IHU and the Émergence calls — their differences, timelines and selection criteria — to plan 12 to 18 months ahead and submit a competitive application.
The Protocolis team8 min read
RIPH classification, RNIPH and European regulation
Every clinical study in France falls under a dual regulatory framework — national (the Jardé Law: RIPH 1/2/3 or RNIPH) and European (CTR, MDR, IVDR). This article offers a step-by-step decision logic and an operational summary table.
The Protocolis team12 min read
Writing a clinical research synopsis
The synopsis is the entry point into the DRCI process. Structuring it well saves weeks in maturing the project. Expected sections, common mistakes and recommendations.
The Protocolis team5 min read
The PICO method in clinical research
PICO breaks the research question down into four dimensions — population, intervention, comparator, outcome — that then drive every methodological decision. An overview of best practices and common mistakes.
The Protocolis team6 min read