A new process for translational research project support is available. The CRT Opendesk, which was set up in 2017, is being replaced by the “Guichet Unique”. This ensures optimal evaluation of projects according to their typology and the associated risks, and that support for researchers can be tailored accordingly.
What projects are involved?
Any project involving:
- Primary human samples or their derivatives
- Individual human data (medical, social, anthropological, genetic, etc.)
- The administration of a health product (drug, vaccine) to humans
- The evaluation of a medical device (computer application for doctors or patients, prosthesis, diagnostic test, etc.)
How does the process work?
A centralization process:
- Scientists contact email@example.com
- In return, they receive a form to be completed
- Scientists return the completed form with a brief description of their project
- Upon receipt of the form 2 project managers appraise the project, after which:
- Either the project is simple from a regulatory or ethical standpoint, in which case it is directly transferred to the support teams
- Or the project is more complex from a regulatory or ethical standpoint, in which case it is brought before the Sponsorship and Monitoring Committee
The Sponsorship and Monitoring Committee:
- Is composed of the Medical Director or his deputy, members of the support teams from the Medical Department, and the Department of Legal Affairs and possibly ad hoc members (ethicists, Data Protection Officer, DARRI, CRB-IP, etc.)
- Meets weekly (unless in exceptional circumstances)
- Appraises the project from an ethical and regulatory standpoint, assesses the risks, the complexity of the project, decides whether to sponsor the project
- Invites the scientist to join the meeting (by telephone or telegram) when particular topics are to be discussed
Back to the scientist:
- A reply is sent to the scientist, including a roadmap and a request for further information if clarifications are needed
- The project could then be supported by the PC-RC or other support teams
The whole process takes place on Teams, ensuring effective interaction between support teams. Some steps will be gradually computerized.