Project: Enhancing Togo's ethical review and regulatory competencies for health research
Acronym | ERUDIT (Reference Number: CSA2017ERC-1917) |
Duration | 01/01/2019 - 30/06/2021 |
Project Topic | Francophone African countries have to catch up in terms of clinical trials and clinical research, and in the ethics review of such research. CBRS (Comite de Bioethique pour la Recherche en Sante) and DPML (Direction de la Pharmacie, du Medicament et des Laboratoires) have partnered with COHRED (conceptual work, sustainability planning, ongoing training in research ethics), TCD eClinical Solutions (installation, technical tranining and technical support for RHInnO Ethics), PharmaEthics (SOP development, virtual REC administration) and Pharmalys (Francophone support, clinical research, training in auditing and inspection activities, monitoring of adequacy of REC review of clinical trials, SOP development, and training in inspection activities) to prepare a high quality proposal. ERUDIT ensures that CBRS and DPML will have the operational knowledge, information system and finances needed to operate a professional research ethics review and regulatory service with particular reference to clinical trials and more widely to health research. The specific aims of ERUDIT are: 1. Equip CBRS with the RHInnO Ethics platform for research ethics review – with appropriate training and back-up.2. Provide training and tele-consultancy services to develop Standard Operating Procedures (SOPs) for the professional administration of CBRS – in a way that such professionalism is immediately available (through virtual REC Administration).3. Provide training in review of clinical trials and clinical research – study design, ethical issues and advanced problems related to emergency situations.4. Provide infrastructure, training and information technology to ensure that the installed RHInnO Ethics can function optimally.5. Support the improvement and maintenance of the dedicated websites for CBRS and DPML.6. Provide access to the growing RHInnO Ethics platform and its resources and services.7. Enable CBRS and DPML to implement financial management to sustain this project.8. Provide support in drafting a code for ethics in human research as the current Code de Santé Publique does not explicitly address human research.9. Provide support to DPML in setting up procedures for the ongoing inspection and enable knowledge transfer.10. Provide assistance for the establishment of a document management system leading to paper free organisations.11. To explore how best to link CBRS to DPML through RHInnO Ethics, for an improved communication and collaboration related to pharmacovigilance aspects.12. Enable on the job training of DPML inspectors with the support from experienced clinical quality assurance experts. |
Network | EDCTP2 |
Call | Ethics and regulatory capacities 2017 |
Project partner
Number | Name | Role | Country |
---|---|---|---|
1 | Ministère de la Santé et de la Protection Sociale | Coordinator | Togo |
2 | Council on Health Research for Development | Partner | Switzerland |
3 | Pharma-Ethics (Pty) Ltd | Partner | South Africa |
4 | Pharmalys SARL | Partner | Senegal |