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[Not Available].

Catherine Cornu1, Clémence Camberlein2, Christine Binquet3

  • 1Inserm, CIC201, Lyon, France ; CHU Lyon, Service de Pharmacologie Clinique, Lyon, France ; Université Lyon, UMR 5558, Lyon, France.

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Summary
This summary is machine-generated.

A new manual standardizes clinical research practices across French Clinical Investigation Centres (CICs). This guide ensures consistent quality in study management and execution nationwide.

Keywords:
bonnes pratiquesclinical investigationclinical researchdémarche qualitégood practicesinvestigation cliniquequality approachrecherche clinique

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Area of Science:

  • Clinical Research
  • Health Services Research
  • Medical Research Infrastructure

Context:

  • Clinical Investigation Centres (CICs) form a national network in France, coordinated by Inserm and DGOS.
  • Specialized working groups and networks exist within the CIC framework.
  • The Harmonisation of CIC Procedures (HPCIC) group developed the manual.

Purpose:

  • To describe the CIC Good Professional Practices manual.
  • To outline the manual's development through consensus and validation by stakeholders.
  • To introduce the manual as a guide for standardizing clinical research.

Summary:

  • The manual is divided into two sections: general CIC management and core activities (coordination, investigation, data management, analysis, valorisation).
  • It was written by consensus, approved by CIC coordinators and external experts, and validated by Inserm and DGOS representatives.
  • The guide is available to all CICs and other research organizations.

Impact:

  • The manual will serve as a basis for quality evaluation, internal audits, and external audits of CICs.
  • It demonstrates the commitment of CICs to standardizing procedures nationwide.
  • The goal is to ensure the highest quality in performing clinical studies for partners.