| The scope of this project is to prepare for the implementation of a central and validated data management system for all sites that participate in the INTERACT programme. The ultimate data management system will have to fulfil the criteria for handling clinical trial data that are required by international standards for conducting clinical trials. A standardisation of the system is crucial to guarantee acceptable and standardized data collection- and management over the different projects of INTERACT. The compliance with international regulations is important for the acceptance of study results into top rank peer reviewed journals, and acceptance of data by international and national communities, which is one of the key objectives of NACCAP. Key characteristic of the implementation of a Good Clinical Practice (GCP) based data management system is the emphasis on defining standard operating procedures (SOP) that will guide the data management process, thus ensuring a constant quality each time a database and other data management tool need to be designed. For this purpose, the selection of an internet based, GCP and 21 CFR part 11 compliant data management system will be the most appropriate ultimate goal. It is recognised that the costs for the fully GCP compliant data management system cannot be absorbed by the NACCAP grant, however, the grant will allow for significant preparation that will pave the way for an internationally accepted system for clinical trials. Within INTERACT there is considerable expertise with high quality data management systems, both in Europe and in developing countries, from preparation of the Case Report Form (CRF) to the release of a validated data set ready for statistical analysis. Building capacity in the data management process in Uganda and Rwanda is guided by this experience. |
