Professionnels

The Sponsorship Unit is located at Saint Philibert Hospital. The unit provides medico-regulatory and logistical support to conduct projects at GHICL. It also helps with projects proposed by other health facilities (institutional or academic projects). The Sponsorship Unit defines the quality assurance policy for research and ensures that all of those involved are properly trained in Good Clinical Practice (GCP).

The different roles:

Sponsor CRA (clinical research associate) :

• Is responsible for regulatory procedures
• Help  in the elaboration of clinical protocols
• Is In charge of the elaboration of the CRF and information letters
• Setsup the necessary circuits (collection of biological samples, pharmacy, etc.)

Monitor CRA :

• Sets up the study and handles the logistics until the study is closed
• Performs monitoring to ensure data quality
• Relays between the sites
• Guarantees that the study is carried out according to the protocol, the regulations in force and the GCP

We will help you to classify the type of studies, based on the tree structure above.

Your project must be submitted to 2 authorities before it can start:

• Ethics committee : The ethics committee issues an opinion (favourable or unfavourable) on Human Subject Research (HSR) projects with regard to the protection of study participants.

In France, there are 39 ethics committees that meet once or twice a month to evaluate clinical research projects.

Once the dossier has been submitted, the ethics committee has 10 days to decide admissibility and 45 days to render its decision

• ANSM : The French National Agency for Medicines and Health Products Safety (ANSM) guarantees patient safety by monitoring the clinical trial from start to end.

Once the dossier has been submitted, the ANSM has 60 days to render its decision (favourable or unfavourable).

Contact us for further information!

Délégation à la Recherche Clinique et à l’Innovation (DRCI)

Hôpital Saint Philibert - Rue du Grand But - BP 249

59462 Lomme Cedex - France

Hôpital Saint Vincent de Paul - Boulevard de Belfort - BP 387

59020 Lille Cedex - France

Tel.: +33 (0)3 20 22 52 69

Pipeline email address: drci@ghicl.net

General sponsorship address: urm@ghicl.net