PA-597 Experiences and lessons learnt in the 13 years of the EDCTP funded EACCR reciprocal monitoring scheme

BackgroundIn April 2010, East African Consortium for Clinical Research (EACCR) in partnership with the University of Oxford initiated the Reciprocal Monitoring Scheme (RMS). This is an innovative, practical and affordable monitoring scheme whose main aim is strategic quality management of health res...

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Veröffentlicht in:BMJ global health 2023-12, Vol.8 (Suppl 10), p.A101-A101
Hauptverfasser: Nanvubya, Annet, Kikaire, Bernard, Kaleebu, Pontiano
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Sprache:eng
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Zusammenfassung:BackgroundIn April 2010, East African Consortium for Clinical Research (EACCR) in partnership with the University of Oxford initiated the Reciprocal Monitoring Scheme (RMS). This is an innovative, practical and affordable monitoring scheme whose main aim is strategic quality management of health research for the 23 institutions that form the consortium. The main role of the RMS is to oversee the progress of clinical trials while ensuring that they are conducted, recorded, reported in accordance with approved Protocols, Standard Operating Procedures (SOPs), applicable local and international regulatory requirements and Good Clinical Practice. We share our experiences and lessons learnt in the past 13 years.MethodsEach institution identified one or two experienced monitors who were paired with unexperienced monitors for mentorship and capacity building. Cross-country pairing was done and monitors were allocated studies to monitor. Physical training was periodically done to refresh skills and brainstorm on experiences.ResultsA regional pool of 42 monitors were trained and paired from 6 Eastern Africa countries and 5 Northern countries. Seven sponsors have been supported to monitor thirty three (33) studies so far. The scheme offered an opportunity for cross-site sharing of best practices and networking at a cheaper cost compared to using conventional clinical research associates. Dedicating time for monitoring activities remains a big challenge for the study team and monitors. ConclusionPaired monitoring fostered capacity building and maximized sharing of best practices for quality management of internationally recognized health research. Cross-country monitoring visits promoted networking and dialogue between researchers, communities and other stakeholders.
ISSN:2059-7908
DOI:10.1136/bmjgh-2023-EDC.247