Clinical Research Unit

• • Instruction and design : the URC of Caen Normandy University Hospital coordinates the instruction and design of clinical research projects, whether they are responses to regional or national calls for tender, but also those requiring support by the university hospital.

• • Project management and monitoring : from the creation of documents to the organization of implementation visits, including monitoring of inclusions, 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 creation and monitoring of regulatory files, necessary for authorization requests from 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 clinical trials. It is responsible for the treatment of serious adverse events (SAEs), within the deadlines imposed by the competent 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 ( ARCs ) ensure the smooth running of clinical research in accordance with regulations and in compliance with the promoter's procedures, from its practical design to its end, in permanent collaboration with the team. "project".

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

The head of regulatory affairs is the promoter's representative for compliance with the Public Health Law, the decrees and orders relating thereto for research projects carried out on individuals by the Caen Normandy University Hospital.

Thanks to its recognized expertise and the involvement of its teams, the URC of Caen Normandy University Hospital offers complete, rigorous and personalized support for the success of clinical research projects promoted by the structure. It plays a strategic role in the development of medical research and the improvement of care practices, thus contributing to public health and therapeutic and biological innovation.

For any request for support regarding a project,
contact us by submitting your request via our counter (link)

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

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

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

The Research Ethics Committee (CER) evaluates the ethical dimension of research projects not covered by a Committee for the Protection of Persons ( CPP ). It guarantees respect for ethical principles (autonomy, beneficence, non-maleficence, justice) by evaluating the benefits and risks of projects. This committee is responsible for:

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

Important: research ethics is a reflexive approach, involving each researcher well beyond obtaining a simple opinion.

How to submit a project to the Guichet d’Orientation?

1. Go to: https://depot-dossier.unicaen.fr/ 
2. Select the Research Ethics Committee procedure
3. To submit a file with a Unicaen email address, log in with the “Connect with SAML” button; otherwise, create an account.
4. Complete the form and attach the required documents
5. If you would like methodological and statistical support , please answer YES to the question: “Do you need support for statistical methodology”
6. Once the file is complete, click on “Send my file”.

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

Review time and follow-up

• CER : files must be submitted no later than four weeks before the monthly meeting. If this deadline is exceeded, you will have the opportunity to submit your file for the following session.

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

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

For certain requested documents (certificate from the research manager, commitment to compliance with MR-004, information notice in the case of MR-004, needs assessment sheet in the event of access to the Health Data Warehouse of Caen Normandy University Hospital), downloadable models are available to you.

Useful contacts

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