Abstract
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.
Highlights
Research site monitoring (RSM) is an effective way to ensure compliance with Good Clinical Practice (GCP)
We realized that non-compliant investigators had not received prior training in good clinical practice (GCP)/Good Clinical Laboratory Practice (GCLP), so we offered them this training
MA, a registered midwife, worked as a research nurse for nine years, trained as a clinical trial monitor in 2011 under the East African Consortium for Clinical Research (EACCR), and was certified as a Clinical Research Associate (CRA) in 2017 by African Clinical Research Organisation (ACRO); she is experienced in monitoring observational studies and clinical trials
Summary
Research site monitoring (RSM) is an effective way to ensure compliance with Good Clinical Practice (GCP). Research Ethics Committees are critical in giving independent corrective review of proposed studies to ensure that the dignity and wellbeing of potential participants are fully protected[1] These committees review study tools such as consent and data collection forms and laboratory and data analysis protocols, to ensure that they align with GCP and Good Clinical Laboratory Practice (GCLP) guidelines[4,6]. Research site initiation procedures and routine monitoring of ethically approved human studies are essential to ensure that all investigators are qualified and competent to undertake the proposed work, required study facilities and tools are available, participants’ rights and safety are protected during data collection, and data is collected accurately to produce reliable results[4]. Continuous monitoring prevents research fraud, minimizes un-ethical practices, enables early detection of protocol deviations, and ensures rightful and effective dissemination of research results[4,6,7]
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