Certification and agreement process
As far as the clinical research projects in CERIMED are concerned, the requests for authorization to the Nuclear Safety Agency (ASN), the Medicines and Health Products Safety Agency (ANSM) and the Pharmacy Inspectorate part of the Regional Health Agency (ARS) are or will be dealt with by the AP-HMaccording to the terms of the convention in the process of being signed.
As regard preclinical projects, the authorizations from the veterinary control services cannot be granted before the delivery of the building.
The conception and realization of clinical research in imaging protocols must be validated by the Technical Committee of the Clinical Investigation Center of Marseilles (AP-HM, Inserm, Aix-Marseille University) and respect the following criteria :
- identified promotor,
- favorable decision of the C.P.P. (Ethic committee for research on hulan beings),
- validation of the budget by the Direction of clinical research of AP-HM,
- respect of scientific, ethic and budgetary criteria, mandatory for all research protocols realized in the C.I.C..,
- feasability (technical conditions, human resources).
Positron-emitting isotopes case
Certain imaging techniques need the use of positron-emitting isotopes of short-life span. These isotopes are produced by nuclear reaction through irradiation of different target materials (gas, liquids, solids) with beams of accelerated particles.
These beams are produced by 2 cyclotrons, property of AAA, installed in a dedicated part of the building (Radiopharmaceutical Department) which is composed as such :
- a sector of production of irradiated products, with the installation of a 18 MeV cyclotron and the neighbouring rooms : access room, control room, gas storage room, hot mecanic, and technical room.
- a research and production sector for radiopharmaceuticals, including product quality control and packaging rooms.
This zoning conforms to regulations of confined spaces in which ionising products are manipulated, as well as, with regard to the space of production and packaging, to the regulations of the production of pharmaceutical products.
Every access to the building will be subject to controls in order to prohibit any unlikely intrusion in CERIMED.
Ethics and Quality
To be completed soon.