Barcelona 2013
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| Abstract #9 - E-Posters English | ||||
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Session: 50.23: E-Posters English (Poster) on Sunday in Chaired by Authors: Presenting Author: Dr Annet Nanvubya - UVRI-IAVI HIV Vaccine Program, Uganda |
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| Additional Authors: Dr. Jordi Casabona, Sra Cristina Sanclemente, Dra. Anna Esteve, Dra. Victoria Gonzalez, Grupo HIVITS TS, | ||||
| Aim: As several rigorous clinical trials and pragmatic health research emerge in resource-limited countries, sponsors and researchers are exploring alternative efficient and affordable ways of attaining high-quality research and ensuring human subject safety comparable to using costly contracted research organizations. In January 2010, the European and Developing Countries Clinical Trials Partnership funded the East African Consortium for Clinical Research to initiate a Reciprocal Monitoring Scheme (RMS) in East Africa. This is an accessible regional pool of trained and experienced health professionals who monitor trials using standardized tools in mutual cross-site visits for strategic quality management and exchange of best practices as a planned part-time activity for each monitor. | ||||
| Method / Issue: Two RMS co-coordinators liaise with research institutional heads, monitors, and principal investigators to address monitoring needs of prioritized trials in the region. The coordinators provide oversight and logistical support. An experienced monitor is paired with a new or less experienced one per site in order to generate an expansible human resource. The assigned pairs conduct introductory and other monitoring visits for trials, where they are not employed. | ||||
| Results / Comments: Twenty eight members of the RMS participated in three refresher monitoring workshops. Twenty two monitors have monitored 12 trials and completed 21 site visits. It has recently attracted consultative requests for the service from 3 regional research sites. | ||||
| Discussion: This alternative approach nurtures more affordable external monitoring of trials while maintaining on-going mutually-rewarding cross-site interactions. It also offers a dependable platform for mentoring new clinical monitors in the region. It is potentially replicable in other resource-limited settings. | ||||
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