Continuous research monitoring improves the quality of research conduct and compliance among research trainees: internal evaluation of a monitoring programme.

Background: Research site monitoring (RSM) is an effective way to ensure compliance with Good Clinical Practice (GCP). However, RSM is not offered to trainees (investigators) at African Institutions routinely. The Makerere University/Uganda Virus Research Institute Centre of Excellence in Infection and Immunity Research and Training (MUII-Plus) introduced internal monitoring to promote the quality of trainees' research projects. Here, we share our monitoring model, experiences and achievements, and challenges encountered. Methods: We analysed investigators' project reports from monitoring visits undertaken from April 2017 to December 2019. Monitors followed a standard checklist to review investigator site files and record forms, and toured site facilities. We planned four monitoring visits for each trainee: one at site initiation, two interim, and a closeout monitoring visit. A team of two monitors conducted the visits. Results: We monitored 25 out of the 26 research projects in progress between April 2017 and December 2019. Compliance with protocols, standard operating procedures, GCP, and GCLP improved with each monitoring visit. Median (IQR) compliance rate was 43% (31%, 44%) at site initiation visit for different monitoring items, 70% (54%, 90%) at the 1st interim monitoring visit, 100% (92%, 100%) at 2nd interim monitoring visit and all projects achieved 100% compliance at site closeout.  All investigators had good work ethics and practice, and appropriate facilities. Initially, some investigators' files lacked essential documents, and informed consent processes needed to be improved. We realized that non-compliant investigators had not received prior training in GCP/GCLP, so we offered them this training. Conclusions: Routine monitoring helps identify non-compliance early and improves the quality of research. We recommend continuous internal monitoring for all research studies. Investigators conducting research involving human subjects should receive GCP/GCLP training before commencing their projects. Institutional higher degrees and research ethics committees should enforce this as a requirement for project approvals

Analysis of the MUII-plus mentorship programme: reflections of Fellows� experiences and lessons for other programmes

Background: The MUII mentorship programme began 11 years ago with a successful group mentorship model. Over the years, the programme has evolved and is presently anchored on the �GROW� approach. This model allows individuals to: set Goals (What I want?); Reflect (Where am I now?); think of Options (What can I do?); What to implement (my actions?). It is intended to help fellows (current, honorary, alumni) herein referred to as mentees achieve their short, medium, and long-term research, career and professional goals. Methods: A mixed methods study combining a cross-sectional survey, one focus group discussion and 11 in-depth key informant interviews were carried out between November 2018 and January 2019 to 1) assess the status of the mentorship programme, 2) perform a strength weakness opportunity and threats (SWOT) analysis, and 3) identify factors relevant for sustainability. Results: An open invitation was made to 52 fellows to participate in the survey, and 23 responded. Among respondents, the largest proportions were male [70% (16/23)], and PhD fellows [35% (8/23)]. The respondents rated the fellowship experience as excellent [65% (15/23)], and most [78% (18/23)] revealed they had benefitted greatly from the programme. The SWOT analysis revealed outstanding strengths of having regular fellows� meetings for peer support, and availability of international collaborations, linkages and exposure. Opportunities identified included large pool of mentees within MUII-plus and evidence of fellows taking up leadership positions. The biggest threat to the mentorship programme was the busy schedule of mentors. Conclusions: The MUII-plus mentorship programme has strong potential to offer research and career mentorship to its fellows. To promote sustainability of the programme, there is a need for innovative ways to engage mentors; such as digital platforms (e-mentorship) for greater mentor-mentee interactions.</ns3:p

Analysis of the MUII-plus mentorship programme: reflections of Fellows’ experiences and lessons for other programmes

Background: The MUII mentorship programme began 11 years ago with a successful group mentorship model. Over the years, the programme has evolved and is presently anchored on the “GROW” approach. This model allows individuals to: set Goals (What I want?); Reflect (Where am I now?); think of Options (What can I do?); What to implement (my actions?). It is intended to help fellows (current, honorary, alumni) herein referred to as mentees achieve their short, medium, and long-term research, career and professional goals. Methods: A mixed methods study combining a cross-sectional survey, one focus group discussion and 11 in-depth key informant interviews were carried out between November 2018 and January 2019 to 1) assess the status of the mentorship programme, 2) perform a strength weakness opportunity and threats (SWOT) analysis, and 3) identify factors relevant for sustainability. Results: An open invitation was made to 52 fellows to participate in the survey, and 23 responded. Among respondents, the largest proportions were male [70% (16/23)], and PhD fellows [35% (8/23)]. The respondents rated the fellowship experience as excellent [65% (15/23)], and most [78% (18/23)] revealed they had benefitted greatly from the programme. The SWOT analysis revealed outstanding strengths of having regular fellows’ meetings for peer support, and availability of international collaborations, linkages and exposure. Opportunities identified included large pool of mentees within MUII-plus and evidence of fellows taking up leadership positions. The biggest threat to the mentorship programme was the busy schedule of mentors. Conclusions: The MUII-plus mentorship programme has strong potential to offer research and career mentorship to its fellows. To promote sustainability of the programme, there is a need for innovative ways to engage mentors; such as digital platforms (e-mentorship) for greater mentor-mentee interactions.</ns3:p

Internal monitoring within MUII-plus for research capacity development

A dataset on 25 projects that provided data on an internal monitoring evaluation of the Makerere University-Uganda Virus Research Institute Centre of Excellence for Infection and Immunity Research and Training (MUII-plus) research programme. The dataset contains 75 variables on projects adherence to the approved protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCP) and Good Clinical Laboratory Practices (GCLP), other applicable regulatory requirements, study related training and presence of adequate facilities required for study related procedures