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 CRT”. 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 one-stop shop:
- Scientists contact firstname.lastname@example.org
- 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 CRT teams
- Or the project is more complex from a regulatory or ethical standpoint, in which case it is brought before the Promotion and Monitoring Committee
The Sponsorship and Monitoring Committee:
- Is composed of the Director of Medical Research or his assistant, members of the CRT and the Department of Legal Affairs and possibly ad hoc members (ethicists, Data Protection Officer, DARRI, etc.)
- Meets twice a month
- Appraises the project from an ethical and regulatory standpoint, assesses the risks, the complexity of the project, decides whether to sponsor the project and appoints a CRT project manager to oversee the project
- The scientist does not participate, but may be called upon if the Committee needs additional information
Back to the scientist:
- A reply is sent to the scientist together with a roadmap and a request for further information if there is a need for clarification
- The project is then overseen by the CRT teams
The whole process takes place on Teams, ensuring effective interaction between support teams. Some steps will be gradually computerized.