AGDAC

Description

Area of Management and Documentation of Clinical Trials. This is the area where all the documentation related to the development of Clinical Trials activity is efficiently organized, controlled, and managed, both by the Institut de Recerca and the Hospital Sant Pau.

This cross-cutting area is a firm commitment to providing optimal working conditions for all professionals associated with it. In this way, compliance with Good Clinical Practices and the Data Protection Law is ensured.

AGDAC was inaugurated on October 24, 2007, thanks to the initiative of the Management, to centralize the documentation of clinical trials that, until that year, was distributed among different departments. Currently, AGDAC is located on the -2 floor of Hospital Sant Pau.

• It involves the custody of documentation associated with active clinical trials in the hospital and the management of documentation from closed clinical trials, sending them to an external custody archive.
• Supervision of the areas of data management and processing and coordination of the monitors’ zone. In addition, coordination of meeting room schedules and monitoring of studies.

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.

Manager

Coordinator

Staff