Reciprocal Monitoring Scheme

In January 2010, the European and Developing Countries Clinical Trials Partnership (EDCTP) funded the East African Consortium for Clinical Research (EACCR) to initiate a Reciprocal Monitoring Scheme (RMS) in East Africa. This is an innovative practical and affordable scheme for strategic quality management of health research in Africa. The scheme provides mentorship for monitoring the quality and ethics of health research. The scheme provided pragmatic ways of ensuring that trials are conducted in accordance with protocols and established standard operating procedures (SOPs); produced reliable data and accurate results; complied with relevant regulations and safeguarded the rights, safety and wellbeing of participants. It 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. The scheme built on the experience of researchers from the Kenyan Medical Research Institute (KEMRI)/ Welcome Research Program in Kilifi who have developed an in-house system for monitoring trials. The scheme is a partnership of 13 research and academic institutions in five East African countries (Tanzania, Uganda, Kenya, Sudan, and Ethiopia). The partner institutions nominated members to constitute the 22- member RMS who were trained in 2 monitoring workshops conducted in February 2011 and May 2012 in Kenya. Eleven experienced monitors were paired with eleven new or less experienced monitors for ‘hands-on’ mentoring in order to increase and sustain capacity. A series of exchange monitoring activities were conducted by the monitors who were allocated in pairs to trials conducted at institutions where they were not employed.  A number of trials (vaccine trials, drug safety studies, longitudinal intervention studies) across Africa were monitored by the scheme. In addition, three (3) consultative requests for services from Principal investigators (PI) were conducted at a fee. Activities of the scheme were coordinated by two experienced monitors (one is based at the Uganda Virus Research Institute in Entebbe and the other at Kenyan Medical Research Institute-US Centers for Disease Control Program in Kisumu). They liaise between monitors, research institutes and investigators to ensure that monitoring activities are conducted as planned. The RMS coordinators were responsible for developing monitoring tools and providing oversight and logistical support. This ‘Network of Excellence’ was administered by KEMRI/CDC Research & public health collaboration, Kisumu Kenya.