Strengthening Clinical Trial Regulatory and Ethical review Oversight in East Africa

Informations projet

ACCESSAFRICA2

N° de convention de subvention: 101103296

DOI

10.3030/101103296

Projet clôturé

Date de signature de la CE 28 Avril 2023

Date de début 1 Juillet 2023

Date de fin 30 Juin 2026

Financé au titre de

• Health

Coût total

€ 600 000,00

Contribution de l’UE

€ 600 000,00

Coordonné par

UNIVERSITETET I OSLO
Norway

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Les liens vers les livrables et les publications des projets du 7e PC, ainsi que les liens vers certains types de résultats spécifiques tels que les jeux de données et les logiciels, sont récupérés dynamiquement sur OpenAIRE .

Livrables

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 (3)

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

Auteurs: 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
Publié dans: Open Research Europe, Numéro 6, 2026, ISSN 2732-5121
Éditeur: 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

Auteurs: 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
Publié dans: Open Research Europe, Numéro 6, 2026, ISSN 2732-5121
Éditeur: F1000 Research Ltd
DOI: 10.12688/OPENRESEUROPE.24264.1

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

Auteurs: 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
Publié dans: Open Research Europe, Numéro 6, 2026, ISSN 2732-5121
Éditeur: F1000 Research Ltd
DOI: 10.12688/OPENRESEUROPE.24163.1