Clinical Trial Documentation Management Area (AGDAC)
Functions
- Manage and supervise all documentation associated with active clinical trials in the experimental phase and destruction of documentation for terminated clinical trials located in the external archive.
- Store the supplies until the end of the studies, when they are destroyed or recycled.
- Oversee and manage documentation of completed trials for the Centre for Drug Research (CIM)
- Maintain and update the clinical workstation database and manage clinical studies.
- Manage restricted access by clinical trial monitors to the clinical workstation.
- Supervise data processing and management.
- Coordinate researchers and monitors; draw up agendas for meetings and study monitoring.
- Provide logistical support to the cold area and the clinical materials store associated with clinical trials in the experimental phase.
- Ship biological samples to central laboratory services..
Facilities
Several areas have been designated to implement these functions:
- Head office and administration area.
- Data processing and management area.
- Clinical trial monitoring meeting rooms.
- Documentation filing area.
- Cold room.
- Archive.