Strengthening Clinical Trial Regulatory and Ethical review Oversight in East Africa

Informazioni relative al progetto

ACCESSAFRICA2

ID dell’accordo di sovvenzione: 101103296

DOI

10.3030/101103296

Progetto chiuso

Data della firma CE 28 Aprile 2023

Data di avvio 1 Luglio 2023

Data di completamento 30 Giugno 2026

Finanziato da

• Health

Costo totale

€ 600 000,00

Contributo UE

€ 600 000,00

Coordinato da

UNIVERSITETET I OSLO
Norway

CORDIS fornisce collegamenti ai risultati finali pubblici e alle pubblicazioni dei progetti ORIZZONTE.

I link ai risultati e alle pubblicazioni dei progetti del 7° PQ, così come i link ad alcuni tipi di risultati specifici come dataset e software, sono recuperati dinamicamente da .OpenAIRE .

Risultati finali

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

Pubblicazioni

Peer reviewed articles (3)

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

Autori: 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
Pubblicato in: Open Research Europe, Numero 6, 2026, ISSN 2732-5121
Editore: 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

Autori: 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
Pubblicato in: Open Research Europe, Numero 6, 2026, ISSN 2732-5121
Editore: 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)

Autori: 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
Pubblicato in: Open Research Europe, Numero 6, 2026, ISSN 2732-5121
Editore: F1000 Research Ltd
DOI: 10.12688/OPENRESEUROPE.24163.1