The second programme of the European and Developing Countries Clinical Trials Partnership (EDCTP2) was launched in 2014 and will be implemented over a 10-year period. The overall objective of EDCTP2 is to contribute to the reduction of the social and economic burden of poverty-related diseases (PRDs) in developing countries by accelerating the clinical development of effective, safe, accessible, suitable and affordable medical interventions for poverty-related diseases, in partnership with sub-Saharan Africa. In EDCTP2, PRDs include: In the EDCTP2 programme, “poverty-related diseases (PRDs)” include HIV, malaria, tuberculosis and the following neglected infectious diseases (NIDs): dengue/severe dengue; rabies; human African trypanosomiasis (sleeping sickness); leishmaniases; cysticercosis/taeniasis; dracunculiasis (guinea-worm disease); echinococcosis; foodborne trematodiases; lymphatic filariasis; mycetoma; onchocerciasis (river blindness); schistosomiasis; soil-transmitted helminthiases; Buruli ulcer; leprosy (Hansen disease); trachoma; yaws; diarrhoeal infections; lower respiratory infections; as well as emerging infectious diseases of particular relevance for Africa, such as Ebola or yellow fever. The EDCTP2 programme supports: • Clinical trials and related research activities on PRDs. All phases of clinical trials (phases I to IV) for new or improved medical interventions, as well as advanced testing and field validation of new diagnostic tools can be supported under EDCTP2 • Capacity development for clinical trials and related research in sub-Saharan Africa. Capacity development activities supported by EDCTP aim to strengthen the enabling environment for clinical research in sub-Saharan Africa, in particular for conducting clinical trials in compliance with fundamental ethical principles and relevant national, Union and international legislation. Moreover, EDCTP2 promotes networking, coordination, alignment, collaboration and integration of national research programmes and activities on PRDs at scientific, management and financial levels. This manual aims to assist applicants to the EDCTP2 programme by providing an overview of the key steps in the EDCTP grant-giving process, and gives guidance and information to applicants on: • How to apply to EDCTP2 calls for proposals (proposal or pre-submission phase: see the chapters 2, 3 and 4) • How applications are processed and evaluated (assessment phase: see chapters 6-9) • The grant contract process for successful applicants (awarding phase: see chapter 10)
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