It was hands on! For Principal Investigators (PIs), Research Ethics Committee – REC personnel (Administrators, Chairs, members, Information Technology officers) and staff of other regulatory agencies, on 17– 18 January 2019, at the Skyz Hotel, Naguru, Kampala. This was at the inaugural training on the Clinical Research Information Management System (CRIMS), jointly hosted by the Uganda National Council for Science and Technology (UNCST), the National Drug Authority (NDA), Uganda National Health Research Organisation (UNHRO), Infectious Diseases Institute (IDI) – Makerere University and Mbale Regional Referral Hospital within the auspices of the Consortium for Clinical Research Regulation and Ethics Capacity Development in Uganda (CREDU). CREDU is a project funded by the European and Developing Countries Clinical Trials Partnership (EDCTP).
Participants were introduced to CRIMS, which is an online platform that provides the researcher with an interface with regulatory agencies for: data capture, data management, data validation, quality control and overall regulatory compliance to clinical research management processes. The institutions which are responsible for regulating clinical research in Uganda are NDA, UNCST, UNHRO, Office of the President and the RECs. CRIMS is a collaboration of three (3) approval processes for clinical research, namely: UNCST, NDA. CRIMS can be accessed through the link https://www.crims.ug/
CRIMS seeks to help institutions which regulate clinical research in Uganda, conduct the a high – quality review of clinical research protocols and to adhere to stipulated turnaround times for protocol approvals. It is envisaged that this platform will ease the research management process by among other things: reducing paperwork; facilitating timely action and feedback on clinical research protocols; enhancing transparency; reducing duplication; and avoiding the practice of “REC shopping.”
The training provided experience and feedback about the platform and its capacity to handle the day-to-day administration of clinical research. Participants made recommendations on all aspects of the platform, including terminologies; additional parameters to improve the data capture; accessibility of the platform by research personnel, etc. A number of issues pertaining to research management and ethics were also discussed in the course of the hands-on activities, including insurance, compensation and regulation of devices for clinical research.
It should be appreciated that CRIMS platform is aimed at easing clinical research management, and as such works in tandem, rather than as a substitute to ethical research practice and adherence to guidelines for clinical research.
Dr. Maxwell Otim Onapa, while presiding over the training, expressed UNCST’s commitment to continued efforts to safeguard the interests, values and rights of human research participants, whose voluntary participation in research provides the country with evidence that in turn informs policies and practices. He urged researchers to exhibit professionalism and ethics in research so as to foster credibility and acceptance of their findings by the public.
By: Deborah Kasule