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Clinical Research Unit

The URC is the operational structure dedicated to clinical research projects promoted by CHU Caen Normandie. Its role is to support health professionals in carrying out their clinical research projects, from the instruction to the promotion of the results obtained, including the design, monitoring and coordination of the study.

Throughout the study, the URC ensures respect for the rights and safety of the patient, it ensures that the trial is carried out in accordance with the protocol, the regulations in force, and according to its internal procedures.


  • Crew

  • Tasks

    Coordination
    • Coordination of the instruction and design of a clinical research project as part of a response to a call for tenders followed by a request for CHU promotion or a request for CHU promotion without response to a invitation to tender;
    • Coordination and management of projects funded by Clinical Research Associates ( CRA ): creation of study documents (CRF, brochures, inclusion sheet, procedures, etc.) / set-up visits (MEP), monitoring, closure / assistance with amendments / management of archiving / center correspondence (letters, telephone contacts, meetings, newsletters, etc.);
    • End of trial coordination: declaration of end of trial and coordination of the writing of the final report for the ANSM ;
    Follow up
    • Follow-up of inclusions, follow-up of monitoring reports, follow-up of MEP and closing reports;
    • Regulatory affairs: creation and follow-up of the regulatory file for authorization requests from the competent authority, the CPP and the CNIL, regulatory monitoring, training on the legislation governing research carried out on the person;
    Vigilance of clinical trials
    • Declaration of SAEs and their follow-up within the imposed deadlines, drafting of annual safety reports, provision by the ANSM of the collection of SAEs/SUEs at any time during the study;
    Drafting & procedures
    • Drafting and implementation of standard operating procedure, operational documents, operating mode, technical sheets contributing to the quality of clinical research;
  • Team functioning

    Regulatory affairs manager

    The regulatory affairs manager is the promoter's representative for compliance with the Public Health Law, the decrees and orders relating thereto for research projects carried out on the person by the CHU Caen Normandie.

    Pharmacovigilant

    The pharmacovigilant is the sponsor's representative for compliance with the rules of vigilance and safety governing the biomedical research promoted by the CHU Caen Normandie.

    The project manager

    The project manager manages and coordinates a portfolio of projects promoted by the CHU on the logistical, organizational and budgetary aspects.

    Clinical research associates

    The clinical research associates ( CRA ) ensure the smooth running of clinical research in accordance with the regulations and in compliance with the promoter's procedures, from its practical design to its end, in permanent collaboration with the "project" team. .