Strengthening Clinical Trial Regulatory and Ethical review Oversight in East Africa

Project Information

ACCESSAFRICA2

Grant agreement ID: 101103296

DOI

10.3030/101103296

Project closed

EC signature date 28 April 2023

Start date 1 July 2023

End date 30 June 2026

Funded under

• Health

Total cost

€ 600 000,00

EU contribution

€ 600 000,00

Coordinated by

UNIVERSITETET I OSLO
Norway

CORDIS provides links to public deliverables and publications of HORIZON projects.

Links to deliverables and publications from FP7 projects, as well as links to some specific result types such as dataset and software, are dynamically retrieved from OpenAIRE .

Deliverables

Documents, reports (12)

Report from desk review of RAs and IRBs
Final joint review guidelines and framework
Training Manual on research leadership
Final proposal for COVID 19 survey
Development and roll out the guidelines and framework to Ethiopia partners
Joint Inspections conduct
Joint review guidelines development and approval
Develop a clinical trial operational manual for NDA
Exploitation and dissemination plan

A plan with a strategy for making the project results known and used will be developed.

Publish summarized evaluation reports of clinical trial applications
Safety monitoring system development
Training Manual on Ethics capacity

Other (1)

Hold annual General Meetings

Data Management Plan (1)

Data Management Plan

A Data Management Plan in line with the FAIR principles will be developed.

Websites, patent fillings, videos etc. (1)

Project website

The Project website communicate and disseminate information about the projects activities and results

Publications

Peer reviewed articles (4)

Collaborative clinical research ethics and regulatory governance in Sub-Saharan Africa: Gaps, challenges and implications

Author(s): Vivian Nchanchou Mbanya, Christopher Ddamulira, Pacifique Ndayishimiye, Marceline Djuidje Ngounoue, Diana Nakitto Kesi, Hiwot Getachew Mekuria, Million Molla Sisay, Gudina Terefe Tucho, Beth Mutumba, Hellen Opolot, Dorcas Lamunu, Rosemarie de la Cruz Bernabe
Published in: Open Research Europe, Issue 6, 2026, ISSN 2732-5121
Publisher: F1000 Research Ltd
DOI: 10.12688/OPENRESEUROPE.24762.1

A Qualitative Exploration of Stakeholder Experiences and Perceptions of Uganda’s Clinical Research Policies and Guidelines During the COVID-19 Pandemic

Author(s): Christopher Ddamulira, Hellen Opolot, Beth Mutumba, Dorcas Lamunu, Steven Ssebale, Irene Semakula, Jacob Komakech, Bernard Kikaire, Helen Byomire Ndagijje, Vivian Nchanchou Mbanya, Rosemarie De La Cruz Bernabe
Published in: Open Research Europe, Issue 6, 2026, ISSN 2732-5121
Publisher: F1000 Research Ltd
DOI: 10.12688/OPENRESEUROPE.24264.1

Strengthening pharmacovigilance systems through Africa-Europe collaboration: Insights from a regulatory roundtable discussion

Author(s): V.N. Mbanya, A. de Jong, P. Ndayishimiye, S. W. Vattekar, V.P. Nambasa, S. Chambiri, C. Ddamulira, H. Opolot, J. Batera, H. B. Ndagije, H. Getachew, A. Duga, C. C Gispen-de Wied, R. Bernabe
Published in: Open Research Europe, Issue 6, 2026, ISSN 2732-5121
Publisher: Open Research Europe/F1000
DOI: 10.12688/OPENRESEUROPE.24694.1)

Navigating ethical research during crisis: Facilitators and barriers to research conduct in Uganda amid the public health emergencies (COVID-19)

Author(s): Christopher Ddamulira, Hellen Opolot, Beth Mutumba, Dorcas Lamunu, Steven Ssebale, Irene Semakula, Jacob Komakech, Bernard Kikaire, Helen Byomire Ndagijje, Vivian Nchanchou Mbanya, Rosemarie De La Cruz Bernabe
Published in: Open Research Europe, Issue 6, 2026, ISSN 2732-5121
Publisher: F1000 Research Ltd
DOI: 10.12688/OPENRESEUROPE.24163.1