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The Pan African Clinical Trials Registry (PACTR) is a regional register of clinical trials conducted in Africa. The registry is an African initiative serving the needs of Africans. It provides a platform where clinical trials can be registered prospectively. In addition, it also provides a searchable, electronic database of planned trials and trials currently in progress. The PACTR is unique in recognising that African trialists face additional challenges in trial registration and seeks to provide feasible ways of overcoming these. For example, a common problem for individuals living in sub-Saharan Africa is limited, unreliable and costly internet access. With this in mind, the registry provides alternative means of trial registration for registrants who do not have reliable access to the internet. Trials may be registered manually by email, postal mail or facsimile correspondence and trial registration is free.

Performing clinical trials in resource-constrained settings requires an affordable and easy to use data management system that is compliant with applicable standards. It is a bold step to adopt a web-based system in a large multi-site clinical trial in an area with challenging communication infrastructure. The process has been successful but not without its challenges. In this presentation, we look at the experience in setting up and use of OpenClinica in Africa with a case study on a large multi-site clinical trial in East Africa that has adopted OpenClinica. The presentation describes the difficulties faced, approaches taken to counter the challenges and best practices adopted. We also propose additional functionality that we believe would make the system more useful in such settings.

Although not intended for clinical trials per se it has a FDA 21CFR-Part11 Compliant Project ongoing and this is planned to be built into the system by the end of 2010