Category : CLINICAL SITES | Date : Mar 29, 2019

The evaluation team was composed of Eva Ariza Vioque, study coordinator (IDIBAPS) and Holy Nandrianina Andriamamonjisoa (IPM).

The purpose of this visit was to assess whether the capacity needs of clinical sites and laboratories are being met and to put in place the appropriate procedures to ensure that all sites are ready to recruit patients and process samples in 2020.
In the clinical sites, the assessed items were about human resources; procedures and performance (i.e. pulmonary/CFS specimen collection, storage and shipment); infrastructure, equipment and supplies; data management and infection control.

In the laboratories, the assessed items were about human resources; procedures and performance (i.e. specimen collection, storage and shipment, GeneXpert procedures, culture procedures, drug sensibility testing…); data management; laboratory infrastructure, equipment and supplies; biosafety control and quality management system.