Akello Mirriam, Coutinho Sarah, N-Mboowa Mary Gorrethy, Bukirwa Victoria D, Natukunda Agnes, Lubyayi Lawrence, Nabakooza Grace, Cose Stephen, Elliott Alison M
Medical Research Council/Uganda Virus Research Institute and London School Hygiene Tropical Medicine Uganda Research Unit, Entebbe, Uganda.
Makerere University/ Uganda Virus Research Institute Centre of Excellence in Infection and Immunity Research and Training (MUII-Plus), Uganda Virus Research Institute, Entebbe, Uganda.
AAS Open Res. 2020 Nov 25;3:57. doi: 10.12688/aasopenres.13117.1. eCollection 2020.
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. 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. 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. 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.
研究现场监测（RSM）是确保遵守《药物临床试验质量管理规范》（GCP）的有效方法。然而，非洲机构通常不会定期为学员（研究者）提供研究现场监测。马凯雷雷大学/乌干达病毒研究所感染与免疫研究与培训卓越中心（MUII-Plus）引入了内部监测，以提高学员研究项目的质量。在此，我们分享我们的监测模式、经验、成就以及遇到的挑战。我们分析了2017年4月至2019年12月监测访视期间研究者的项目报告。监测人员按照标准检查表审查研究者的现场文件和记录表格，并巡视现场设施。我们为每位学员计划了四次监测访视：一次在项目启动时，两次中期访视，以及一次结束监测访视。由两名监测人员组成的团队进行访视。我们对2017年4月至2019年12月期间正在进行的26个研究项目中的25个进行了监测。随着每次监测访视，对方案、标准操作规程、GCP和《药物临床试验伦理审查规范》（GCLP）的遵守情况都有所改善。不同监测项目在项目启动访视时的中位（四分位间距）合规率为43%（31%，44%），在第一次中期监测访视时为70%（54%，90%），在第二次中期监测访视时为100%（92%，100%），所有项目在项目结束时均达到100%合规。所有研究者都有良好的职业道德和实践，以及适当的设施。最初，一些研究者的文件缺少关键文件，知情同意程序需要改进。我们意识到，不符合规定的研究者此前未接受过GCP/GCLP培训，因此我们为他们提供了该培训。常规监测有助于早期发现不符合规定的情况，并提高研究质量。我们建议对所有研究进行持续的内部监测。进行涉及人类受试者研究的研究者在开始项目前应接受GCP/GCLP培训。机构的高等学位和研究伦理委员会应将此作为项目批准的一项要求予以执行。
