SCALING UP CAPACITY TO SUPPORT CONDUCT OF CLINICAL TRIALS IN THE EAST AFRICAN COMMUNITY

Informazioni relative al progetto

SCALE-IT

ID dell’accordo di sovvenzione: 101103332

DOI

10.3030/101103332

Progetto chiuso

Data della firma CE 11 Maggio 2023

Data di avvio 1 Giugno 2023

Data di completamento 31 Maggio 2026

Finanziato da

• Health

Costo totale

€ 600 312,50

Contributo UE

€ 600 000,00

Coordinato da

EPICENTRE
France

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 (17)

Support Dissemination

KEMRI will support IDI for dissemination activities.

Stakeholder’s meeting report

The technical team comprising of PI, project co-investigators and hired content experts will conduct a stakeholders workshops to ascertain the current state of the gaps the project aims to address to ensure that the project is centred around meeting their needs. Stakeholders workshops will have representatives from the East African Community partner states, national regulatory bodies and all implementing partners. Implementation will be done based on the findings of this baseline report from stakeholders meeting

Curriculum on personal effectiveness and leadership skills

An updated curriculum following stakeholders meeting will be available

Publications in open access journal

workshops to disseminate project evaluation findings. We shall prepare manuscripts for publications following recommendations from the stakeholders meeting, and project evaluation. At all time, we shall abide by the EU and EDCTP3 funding acknowledgement format on all communication and dissemination.

TAC terms of reference

A Technical Advisory Committee (TAC) comprising of at least 1 member from each partner state and 2 international members will be constituted to oversee management of the project planned trainings and will meet quarterly to deliberate on the project based on the agreed terms of reference

Updated curriculum clinical trial monitoring

An updated training curriculun will be available following considerations from the stakeholder's meetings

Training report clinical trial monitoring

Epicentre lean in training in clinical trial monitoring. IDI will support epicentre in identifying a pool of trainers who will review/develop training materials. In order to update the online course version, trainers will record their presentations with a voice over together with the training department, which will be edited and uploaded on the e-learning platform; -Moodle Platform. The Trainees will include participants from the East African Community partner states in the EAHRC. The trainings for NRRAs,and clinical trial monitors will be pooled from all the EAC partner states due to the few numbers as well as targeted number. The participants will be identified through the EAHRC focal points and secretariats of NRRAs of the implementing partner states such as UNCST and NDA of Uganda and research organisations. The trainers will conduct trainings using a blended approach [face to face and virtual sessions]. The IDI training and capacity development team will coordinate training preparations like sending invitations to participants and identifying suitable training venues. The team will also oversee training logistics management and conduct training evaluations that will feed into the final training report.

Project initiation meeting Notes

An inaugural project meeting will be held to ensure that all consortium members establish rapport and align priorities for achieving project goals and objectives

Training report on emerging and complex

IDI will identify a pool of trainers who will review/develop training materials. In order to update the online course version, trainers will record their presentations with a voice over together with the training department, which will be edited and uploaded on the e-learning platform; -Moodle Platform. The Trainees will include participants from the East African Community partner states in the EAHRC. The trainings for NRRAs, researchers, clinicians in research will be pooled from all the EAC partner states due to the few numbers as well as targeted number. The participants will be identified through the EAHRC focal points and secretariats of NRRAs of the implementing partner states such as UNCST and NDA of Uganda. The trainers will conduct trainings using a blended approach [face to face and virtual sessions]. The IDI training and capacity development team will coordinate training preparations like sending invitations to participants and identifying suitable training venues. The team will also oversee training logistics management and conduct training evaluations that will feed into the final training report.

Training report on personal effectiveness and leadership skills

IDI will identify a pool of trainers who will review/develop training materials. In order to update the online course version, trainers will record their presentations with a voice over together with the training department, which will be edited and uploaded on the e-learning platform; -Moodle Platform. The Trainees will include participants from the East African Community partner states in the EAHRC. The participants will be identified through the EAHRC focal points and secretariats of NRRAs of the implementing partner states such as UNCST and NDA of Uganda. The trainers will conduct trainings using a blended approach [face to face and virtual sessions]. The IDI training and capacity development team will coordinate training preparations like sending invitations to participants and identifying suitable training venues. The team will also oversee training logistics management and conduct training evaluations that will feed into the final training report.

Dissemination, exploitation and communication plan

The IDI communications team will work with the technical team to develop and implement a dissemination, exploitation and communication plan.

Project communications impact report

The communications team will track the impact and reach of the project activities on the various platforms used for dissemination and evalaute the impact.

Updated curriculum on emerging and complex study design

An updated training curricula using recommendations from the stakeholder meetings on emerging and complex study designs

Presentation at national and international conferences

We will support the annual national research ethics conference in Uganda by supporting delegates from the project partner states to attend the conference. A dedicated panel session for the project will be arranged to disseminate project activities and findings

TAC meeting notes

A Technical Advisory Committee (TAC) will meet quarterly to deliberate on the project based on the agreed terms of reference

Support Training

Kemri will be involved in the training work package by being a focal person in Kenya for the training programs. Kemri will support IDI in delivery of the training wp3.

Project news letters

A project newsletter will be prepared annually highlighting the project activities and those of partners.

Websites, patent fillings, videos etc. (2)

Web and social media posts

The communications team will create social media accounts including twitter, LinkedIn, which will be tagged to the IDI social media channels

Web page

The communications team will design a project webpage on the IDI website where project activities will be showcased and these feeds will also be linked to our partners’ websites

Data Management Plan (1)

Data management plan

The data management plan will be developed to guide the management and analysis of data collected during the project time

Pubblicazioni

Peer reviewed articles (2)

Strengthening research regulatory capacity in the East African community: a multi-country training program on emerging and complex study designs

Autori: Mathius Amperiize, Belinda Twesigye, Beth Mutumba, Hellen Opolot, Soazic Gardais, Steve Wandiga, Helen Ndagije, Jeremiah Kidola, Vincent Mutabazi, Ramadhan Nyandwi, Lina S. Mathew, Novat Twungubumwe, Barbara Castelnuovo, Joseph Walter Arinaitwe, Stephen Okoboi, Provia Ainembabazi, Pauline Byakika-Kibwika
Pubblicato in: BMC Medical Ethics, 2026, ISSN 1472-6939
Editore: Springer Science and Business Media LLC
DOI: 10.1186/S12910-026-01418-2

Strengthening capacity for clinical trial monitoring in the East African community: a multi-country training programme

Autori: Belinda Twesigye, Mathius Amperiize, Steve Wandiga, Barbara Castelnuovo, Stephen Okoboi, Beth Mutumba, Hellen Opolot, Helen Ndagije, Soazic Gardais, Jeremiah Kidola, Vincent Mutabazi, Ramadhan Nyandwi, Lina S. Mathew, Novat Twungubumwe, Provia Ainembabazi, Pauline Byakika-Kibwika
Pubblicato in: BMC Medical Education, 2026, ISSN 1472-6920
Editore: Springer Science and Business Media LLC
DOI: 10.1186/S12909-026-09664-Z