Section 4: Conditions for authorising certain research sites

The issue of the site authorisation provided for in the second paragraph of Article L. 1121-13 is subject to compliance with the following conditions:

1° The possibility of ensuring appropriate supervision of persons undergoing research and, in the event of an emergency, emergency care and immediate transfer to an appropriate care service;

2° Where appropriate, a number of beds commensurate with the planned activities;

3° An organisation to ensure the conservation and confidentiality of data and information relating to the research and the persons involved and, where appropriate :

a) Collecting, preparing and storing biological samples ;

b) To store, under appropriate conservation conditions, the products used in the course of the research;

c) Ensuring the maintenance of medical equipment and devices and the quality control of medical equipment and devices as mentioned in article R. 5212-26 ;

d) If meals are prepared, to have separate premises reserved for this purpose;

4° The conditions for fitting out, equipping, hygiene, maintenance and operation as well as the necessary qualifications of the staff working in these research facilities to ensure the safety of individuals and the quality of the data collected, and which are specified, where necessary, by order of the Minister for Health;

5° The implementation of a quality assurance system;

6° Where the authorisation includes the operations provided for in the fourth paragraph of Article L. 1121-13, the site has :

a) A pharmacist with at least one year's practical experience in the packaging and labelling of investigational medicinal products;

b) Premises, equipment and personnel suitable for the supply, packaging and labelling of investigational medicinal products and the corresponding storage operations required for the research carried out at these sites.

In the case of outpatient research, provisions are made to ensure the same safety guarantees.

When the research concerns patients whose state of health requires hospitalisation, the research may not take place outside a health establishment.