Clinical Research Unit

• • Instruction and design : the URC of the CHU of Caen Normandie coordinates the instruction and design of clinical research projects, whether they are responses to regional or national calls for tenders, but also those requiring support from the CHU.

• • Project management and monitoring : from document creation to organizing site visits and monitoring enrollment, the URC ensures rigorous and transparent control. Each step is documented through detailed reports, guaranteeing optimal traceability.

• • Regulatory support : The URC provides essential support for the preparation and monitoring of regulatory files, necessary for applications for authorizations to the competent authorities.
• • Training : The URC organizes regular training sessions for investigators and research teams on legislation governing research involving people, ensuring that all stakeholders are informed of the latest regulatory and ethical requirements.

The URC is committed to maintaining rigorous vigilance throughout the clinical trials. It is responsible for managing serious adverse events (SAEs) within the timeframes mandated by the relevant authorities.

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

Clinical research associates ( CRAs ) sponsors ensure the smooth running of a clinical research study in accordance with regulations and in compliance with the sponsor's procedures, from its practical design to its completion, in ongoing collaboration with the "project" team.

The pharmacovigilance officer is the representative of the sponsor for compliance with the vigilance and safety rules governing biomedical research sponsored by the Caen Normandy University Hospital.

The regulatory affairs manager is the sponsor's representative for compliance with the Public Health Law, decrees and related orders for research projects conducted on human subjects by the Caen Normandy University Hospital.

Thanks to its recognized expertise and the dedication of its teams, the Clinical Research Unit (URC) at Caen Normandy University Hospital offers comprehensive, rigorous, and personalized support for the success of clinical research projects sponsored by the unit. It plays a strategic role in the development of medical research and the improvement of healthcare practices, thus contributing to public health, therapeutic innovation, and biological advancements.

For any project support request,
please contact us by submitting your request via our online portal (link).

Or by writing to the following address:
drci-secretariat@chu-caen.fr

Do you have a research project not involving human subjects (retrospective or prospective data reuse),
a thesis or a dissertation to complete?

The Caen Normandy University Hospital and the University of Caen Normandy have set up a single Guidance Desk (GO) to guide you at each stage: methodological, statistical, regulatory, and ethical.

The Research Ethics Committee (REC) assesses the ethical dimension of research projects not falling under the purview of a Research Ethics Committee ( REC ). It ensures respect for ethical principles (autonomy, beneficence, non-maleficence, justice) by evaluating the benefits and risks of the projects. This committee is responsible for:

• Studies not involving human subjects.
• Reuse of data for theses, dissertations, scientific articles.

Important: Research ethics is a reflective process, involving each researcher far beyond simply obtaining an opinion.

How to submit a project to the Guidance Desk?

1. Go to: https://depot-dossier.unicaen.fr/ 
2. Select the Research Ethics Committee procedure
3. To submit an application with a Unicaen email address, log in using the "Log in with SAML" button; otherwise, create an account.
4. Fill out the form and attach the required documents
5. If you require methodological and statistical support , please answer YES to the question: "Do you need support with statistical methodology?"
6. Once the application is complete, click on "Submit my application".

The compliance (with regard to the General Data Protection Regulation – GDPR) of your database will be checked in parallel.

Examination time and follow-up

• CER : Applications must be submitted no later than four weeks before the monthly meeting. If this deadline is missed, you will have the option of submitting your application for the following session.

The CER's opinion will be communicated to you no later than two weeks after the meeting.

• Methodological COTECH : meeting on the 1st ^Tuesday of each month, the decision will be given to you in the following days.

For certain documents requested (attestation of the research manager, commitment to comply with MR-004, information notice in case of MR-004, needs assessment form in case of access to the Health Data Warehouse of the University Hospital of Caen Normandy), downloadable templates are available.

Useful contacts

• CER : martin-aude@chu-caen.fr (CER coordinator)
• Methodological COTECH contact : drci-secretariat@chu-caen.fr
• Regulatory affairs and data protection : chaillot-f@chu-caen.fr