Accreditation is a quality assessment carried out by a team of peer experts (team of assessors) based on established quality standards, to obtain recognition that an institution or program study has met the specified quality standards, making it feasible to carry out its program. The establishment of a Research Data Center at CISM is within the general EDCTP aim of improving clinical research in sub-Saharan Africa in Sub-Saharan Africa. 

The enhancement of the CISM’s IT infrastructure started in the first program of TESA as part of Capacity Building and infrastructure upgrading. The Date Centre at CISM in Maputo-Mozambique was identified to be accredited. Data Capture Devices were acquired and the corresponding system installed.

The present project seeks to establish, in the sub-Saharan Africa region, a reference data centre that will provide high quality, compliant, and safe data management, as well as effective management of the underlying systems and IT infrastructure, to attend to the ever-increasing demand, in the region, for the conduct of clinical research, and clinical trials in particular.

Main objectives:

• To create at CISM a Reference Data Center to be used by the TESA network to support multinational clinical trials (CT)
• To build the infrastructure of high-quality multinational CT in African countries and the certification process to be replicated and lessons learned spread across the network

150 ECRIN standards

• Upgrade basic IT infrastructure, while developing staff competencies in DM
• Upgrade System: Data management practices (quality clinical data)