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.

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.