1. health and fitness
2. disease
3. infertility

DMS # 72347-V1
EDCTP Report for the Regional Networks of Excellence
Submission of individual reports per site will no longer be accepted by EDCTP. Project Coordinators are requested to submit
ONE consolidated report per Network
Call Scheme
Report type
Report
Reporting period
Capacity-building
Annual
Fifth
From [16th May 2013] To [31st March 2014] (Year 5)
SECTION A: PROJECT PROFILE
This information is used in the Project Profile published on the EDCTP website
Project Coordinator
Please provide a recent photograph for your profile
Annex 1
Name: Prof. Pontiano Kaleebu
EDCTP grant code
CB.07.41700.001
Name of Network
EACCR
Grant title
The East African Consortium for Clinical Research: A capacity-building network of excellence,
training and mentorship in the conduct of clinical trials in Africa
Coordinating Institution
Email Address: [email protected]
Uganda Virus Research Institute (UVRI)
P.O Box 49
Entebbe (Uganda)
51-59 Nakiwogo Road
Phone: +256 417704103
Country
Uganda
Total number of sites/institutions*
35 institutions
Number of active sites contributing to this report
17 regional leading & 18 sister institutions continue to be active members
Grant start and end date
From
Value of EDCTP grant
3.5 million euros
16th May 2009
To
31st December 2014
*only applies to sites with legal entity status
EDCTP -East African Consortium for Clinical Research 5th Year report (2)
Page 1 of 25
DMS # 72347-V1
1.1
List of collaborators
Please provide details of the work package leaders and other collaborators on the grant, indicating their role in the project (for example, project coordinator,
PhD and MSc supervisor, site PI, work package leader, etc). Where collaborators have more than one role, please provide details.
Site/Institution
Country
Active
(Y/N)*
Role in Network
Overall project
coordinator
HIV
Male
Prof. Pontiano Kaleebu
Former Director
MRC/UVRI Unit &
co-applicant
Deputy Overall
project
coordinator
Facilitator of
capacity-building
activities & coapplicant
Co-applicant &
Head of institution
HIV
Male
TB
Male
[email protected]/
[email protected]
Immunology
& Infectious
Diseases
Female
[email protected]
Malaria
Male
[email protected]
Chairman EACCR
Steering
committee &
Director, UVRI
Malaria node
coordinator
HIV, Bioethics,
oncology
Male
[email protected]
Malaria
Male
[email protected]
Member, EACCR
Steering
committee &
training/mentorin
g
Member, EACCR
Steering
committee &
Head of IHI
Malaria,
clinical trials,
Training (elearning)
Female
[email protected].
uk
Malaria
Male
[email protected]/
[email protected]
Y
1. Uganda Virus
Research Institute
Uganda
2. MRC/UVRI
Research Unit
Uganda
3. Kilimanjaro
Christian Medical
Centre (KCMC)
Tanzania
Y
Prof. Heiner Grosskurth
Y
Prof. Gibson Kibiki
Y
4. MRC/UVRI
Research Unit
5.
Kenya Medical
Research InstituteKilifi
Uganda
Prof. Alison Elliott
Y
Kenya
Prof. Kevin Marsh
Y
6. Uganda Virus
Research Institute
Uganda
7. Kenya Medical
Reserach Institute
Kenya
Dr. Edward Katongole
Mbidde
Y
Dr. Nobert peshu
Y
8. University of
Oxford
9. Ifakara Health
Research InstituteIHI
UK
Dr. Trudie Lang
Y
Tanzania
Area of
expertise
Name of collaborator
Dr. Abdulla Salim
EDCTP -East African Consortium for Clinical Research 5th Year report (2)
Gender
Current email
Pontiano.Kaleebu@mrcug
anda.org/pkaleebu@infoco
m.co.ug
heiner.grosskurth@gmail.
com
Page 2 of 25
DMS # 72347-V1
Site/Institution
10. National Institute
for Medical
Research – Mwanza
11. National Institute
for Medical
Research – Mwanza
12. Armauer Hansen
Reserach Institute
(AHRI)
13. Muhimbili
University of Health
and Allied Sciences
(MUHAS)
14. Institute of
Endemic Diseases
(IEND)
15. Muhimbili
University of Health
and Allied Sciences
(MUHAS)
16. National Institute
for Medical
Research Dar es
Salaam
17. National Institute
for Medical
Research –
Muhimbili
18. National Institute
for Medical
Research –
Muhimbili
19. Muhimbili
University of Health
and Allied
Sciences(MUHAS)
Country
Active
(Y/N)*
Name of collaborator
Y
Tanzania
Dr. John Changalucha
Y
Tanzania
Mr. Mark Urassa
Y
Canadian
Prof. Engers Howard
Y
Tanzania
Dr. Muhammed Bakari
Y
Sudan
Prof. Maowia Mukhtar
Y
Dr. Patricia Jane
Munseri
Tanzania
Y
Dr. Mwele Ntuli
Malecela
Tanzania
Y
Dr. Sayoki Godfrey
Mfinanga
Tanzania
Y
Tanzania
Dr. Beatrice K Mutayoba
Y
Tanzania
Role in Network
Area of
expertise
Gender
Current email
Member, EACCR
Steering
committee &
Head of site
Facilitator, HIV
activities
Medical
microbiology
Male
[email protected]
HIV
Male
[email protected]
Supervisor
Training & coapplicant
Mentoring & coapplicant
Training
Male
[email protected]/en
[email protected]
HIV, Training
Male
[email protected]/mba
[email protected]
Facilitator of
EACCR capacitybuilding activities
Facilitator of
EACCR capacitybuilding activities
Malaria,
Training
Male
mmukhtar@tropmedicine.
org
Training
Female
[email protected]
Vice chair,
Steering
Committee &
Director General –
NIMR
TB node
coordinator
Neglected
infectious
diseases
Female
[email protected]/
[email protected]
TB
Male
[email protected]
Facilitator of
activities in the
TB Node
Scientist-TB
Female
[email protected]/be
[email protected]
m
Trainer
Training
Male
[email protected]
Prof. Japhet Killewo
EDCTP -East African Consortium for Clinical Research 5th Year report (2)
Page 3 of 25
DMS # 72347-V1
Site/Institution
20. Muhimbili
University of Health
and Allied
Sciences(MUHAS)
Country
Active
(Y/N)*
Name of collaborator
Y
Tanzania
Prof. Eligius Lyamuya
Y
21. Uganda Virus
Research Institute
Uganda
22. KEMRI/CDCKisumu
Kenya
23. Walter Reed
Project/KEMRI
Kisumu
24. University of
Nairobi/Kenya
AIDS Vaccine
Initiative (KAVI)
25. Maseno University
Dr. Jonathan Kayondo
Y
Mr. Stephen Wandiga
Y
Kenya
Dr. Berhards Ogutu
Y
Dr. Walter Godfrey
Jaoko
Kenya
Kenya
Y
Prof.Ofulla Ayub V.O
Y
26. Ugandan Ministry
of Health
Uganda
Dr. Asuman Lukwago
Y
27. St Rapheal
Nsambya Hospital
Uganda
Dr. Martin Nsubuga
N
28. NIMR-Tabora
Tanzania
29. National Institute
for Medical
Research -Tanga
Tanzania
Dr. Zakayo Mrango
Y
Dr. Martha Lemnge
EDCTP -East African Consortium for Clinical Research 5th Year report (2)
Role in Network
Area of
expertise
Member, steering
committee &
Trainer
HIV,
microbiology,
immunology
Male
[email protected]
Member,
implementation
committee
HIV, malaria,
molecular
biology, bioinformatics
TB
Male
[email protected]
Male
[email protected]
Malaria
Male
[email protected]
HIV,
microbiology,
training
Male
[email protected]
Malaria,
training
Internal
medicine,
policy
Male
[email protected]
Male
[email protected]
Internal
medicine
Male
[email protected]
o.uk/
martin.nsubuga.dr@gmail.
com
Parasitology,
Human
African
Trypanosomia
sis
Malaria
Male
[email protected]
Female
[email protected]
m
Trainer/facilitator
of capacitybuilding activities
Steering
committee
member
Co-applicant &
trainer
Co-applicant,
trainer
Steering
committee
member, coapplicant
Director of sister
site, co-applicant,
source of
potential
participants
Representative of
sister site, coapplicant, source
of potential
participants
Director of sister
site, co-applicant
Gender
Current email
Page 4 of 25
DMS # 72347-V1
Site/Institution
Country
Active
(Y/N)*
Name of collaborator
Y
30. NIMR-Mbeya
Tanzania
31. University of
Munich
Germany
32. Karolinska Institute
Sweden
Dr. Leonard Maboko
N
Dr. Michael Hoelscher
Y
Prof. Eric Sandstrom
Y
33.Masaka Hospital
34.Centre for
International Health,
University of Bergen
35.KNCV Tuberculosis
Foundation
36. Goteborg
University
37. Infectious Disease
Institute- Mulago
38. Radbourd
University Medical
center Nijmmegen
(RUMCN)
Dr. Florence
Tugumisirize
Uganda
N
Norway
Netherlands
Sweden
Uganda
Netherlands
Prof. Odd Morkve
N
N
Y
N
Dr. Van der Leth
Prof. Ashton Michael
Dr. Andrew Kambugu
Prof. Van der Ven
Role in Network
Area of
expertise
Gender
Current email
Site Director,
Steering
committee
member
Steering
committee
member
Steering
committee
member
Director of sister
site, source of
potential
participants
CollaboratorNorthern partner,
co-applicant
Advisor TB
research
HIV
Male
[email protected]
TB
Male
[email protected]
HIV
Male
Eric.sandstrom@karolinsk
a.se
Paediatrics,
epidemiology
Female
[email protected]
or masakarrh.gmail.com
TB
Male
[email protected]
TB
Male
[email protected]
Training
Training
Male
[email protected]
Facilitator of
capacity-building
HIV
Male
[email protected]
CollaboratorNorthern partner,
co-applicant
Networking
Male
[email protected]
*Active: Sites involved with EDCTP-funded project activities during the current reporting period
Please submit copies of CV’s of any new collaborators as supporting annexes
EDCTP -East African Consortium for Clinical Research 5th Year report (2)
Page 5 of 25
DMS # 72347-V1
1.2
Abstract (max 850 characters)
Give a summary of the project and what was achieved, including the aims and objectives, research questions being addressed, study methods, results, findings
and achievements of the project.
Introduction: Since May 2013, the East African Consortium for Clinical Research (EACCR) has continued its collaboration with the 35 17 leading regional
stitutions and 7 northern partners to support initiatives towards conduct of multi-centre clinical trials (on drugs, devices and other solutions), capacity
development and networking. The leading institutions work closely with other 18 sister sites. The Network addresses challenges of fragmented/uncoordinated
efforts, diminishing indigenous scientists, insufficient funds and inadequate infrastructure in Eastern Africa in partnership with the policy makers. EACCR
integrates scientists, health practitioners, academicians and policy makers from the region (including Ethiopia and Sudan) and Europe. It has networked actively
with other research consortia and development partners in Africa Europe and Northern America (Canada).
Methods: With guidance of EDCTP, we held consultative stakeholder meetings, Networking, document review, email discussions and teleconferences between
May 2013-March 2014. EACCR’s work packages are categorized into: governance, training, infrastructure, research and networking. Governance is structured
regionally into 4 coordinating centers: Malaria (Kenya), TB (Tanzania), HIV (Uganda) and Training (Tanzania). We leveraged the main framework programme 6
(FP6) grant, the coordination support action (CSA) subgrant and the additional core support funds to consolidate key operations in the Network.
Results and achievements: We maintained a consensus-governed and networked consortium whose contract with EDCTP has been extended to December
2014. This Network has also secured additional 95, 000 euros from EDCTP for essential operational and preparatory activities to respond to the upcoming EDCTP
2 grant calls. EACCR has contributed to: 2 additional published peer-review articles; training 10 regional scientists in 5 short courses; supporting 6 on-going
masters degree students sponsored by EDCTP and 10 networking events. One of its EDCTP senior fellows was successfully awarded an African Research Leaders’
grant of up to 5 years support in mental health and capacity-building. Two more grant applications have been submitted by the TB node to sustain Network
activities. In addition, other affiliated institutions have had more publications and co-funding mechanisms.
Kindly note that this space is expandable
1.3
Description of the project
The project description should cover background, objectives, results and outcomes, capacity building and networking (max: 5000 characters).
Background
EACCR is an Eastern African-led, EDCTP-enabled network that was established in May 2009 to contribute to: health research coordination; increased active mass
of African scientists and research administrators; upgraded infrastructure; stronger networking and advocacy for conducting clinical trials or other research on
HIV, Malaria, TB and other diseases of public health importance under best practices. It has 35 regional institutions from Kenya, Uganda, Tanzania, Ethiopia and
Sudan in partnership with 7 northern partners. It coordinates & promotes health product innovation, capacity development and networking in Eastern Africa for
improved health and social advancement of its population.
Objectives




To
To
To
To
strengthen regional research coordination and infrastructure for multi-centre clinical trials plus other health research
enable less developed sites within EACCR to improve their capacity to participate in multi-centre clinical trials through mentorship and collaboration
plan and support training/mentoring of promising regional scientists and administrators through both short and long term courses
contribute to improved strategic quality management of research through an affordable reciprocal monitoring scheme
EDCTP -East African Consortium for Clinical Research 5th Year report (2)
Page 6 of 25
DMS # 72347-V1


To apply an interactive website for better communication, enhanced networking, advocacy, common databases and training
To promote advocacy for: regionally-owned research and health agenda; research use in policy and programming and resource mobilization
Results and outcomes
EACCR contributed to 2 published peer-review articles in year 5 (annexes 1 and 2). It trained 10 regional scientists through 5 short courses conducted during this
period. This Network also supported 6 continuing masters degree students sponsored by EDCTP. We maintained a consensus-governed and networked consortium
whose contract was amended and extended to December 2014. EACCR has secured additional funds (95,000 euros) for core support functions in 2014. The
consortium has engaged meaningfully in 10 networking events outlined below to increase its contributions to research plus capacity-building and visibility. In
addition, other affiliated institutions have had more publications and co-funding mechanisms.
Capacity building
The Hon. Minister of State for Health in charge of primary health care, Dr. Sarah Opendi, was invited by EDCTP and EACCR to participate in a high-level meeting
for policy makers in Dakar, Senegal on the 21st October 2013. Prior to this EDCTP meeting, EACCR secretariat updated her on the: contributions, activities of
EDCTP in Uganda and the region; purpose of the scheduled meeting; possible areas of engagement by the Ugandan Ministry of Health and the challenges that the
Network has experienced (annex 3: policy brief).
EACCR continued to support 6 on-going Masters degree students sponsored by EDCTP and also trained 10 scientists and health workers through 5 short courses
mentioned in section D below. Our pool of clinical monitors and research staff are now able to access an accredited open online research ethics course with the
support of the Global Health Network website. More planned infrastructure upgrades were implemented at KCMC/KCRI as described in section D. The Network
continued to work with the EDCTP Africa office and The Hague to coordinate and execute the EDCTP stepwise laboratory accreditation programme and the
financial audit processes.
Networking







The HIV node coordinator and Network scientific liaison officer participated through learning observation in a Joint planning meeting of WANETAM and
CANTAM in Dakar, Senegal in June 2013 with facilitation from EDCTP so that EACCR could hold a similar joint capacity-building event with TESA in July
2013 (Refer to photograph in annex 4)
Mrs. Emily Nyanzi, the project manager, attended an evaluation meeting of MDGs organised by the Ugandan Economic Policy and Research Centre (EPRC)
and UK Aid at Sheraton Hotel Kampala, Uganda in June 2013
The HIV node coordinator and Network scientific liaison officer was invited and attended some of the scientific presentations and the annual general
meeting of the Welcome Trust-funded THRiVE consortium (www.thrive.or.ug) in Kampala, Uganda, 10-12 July 2013
EACCR participated in and contributed to a joint planning meeting of stakeholders from EACCR and TESA in Johannesburg, South Africa in mid July 2013
(see annex 5: SAPESA report)
Prof. Kaleebu and Mr. Tom Lutalo attended and participated in the HIV stakeholders’ meeting in Lisbon, Portugal, 3rd - 4th september 2013
Dr. Sarah Opendi attended the EDCTP High-level meeting in Dakar, Senegal on 21st October 2013 upon the invitation of EDCTP and EACCR.
The HIV node coordinator participated in a skills-sharing workshop on sexual and reproductive health organized by the Canada-Africa Prevention Trials
Network at the Infectious Disease Institute, Mulago Hospital, Uganda in December 2013 (Refer to annex 6)
EDCTP -East African Consortium for Clinical Research 5th Year report (2)
Page 7 of 25
DMS # 72347-V1



1.4
Dr. Reginald Kavishe, the assistant training node coordinator, from KCMC represented EACCR at the WANETAM annual general meeting (AGM) in Dakar,
Senegal, 16-18 December 2013
Dr. Miiro, the HIV node coordinator and Network liaison officer, attended an EU-funded information dissemination workshop on the released Horizon 2020
calls hosted by the Uganda National Council for Science and Technology (UNCST) in Kampala, Uganda on 22nd January 2014 followed by another
workshop by UNCST at UVRI on the same subject in February 2014. Refer to annex 7.
Dr. Miiro attended the 11th TaMoVac meeting in Dar es Salaam, Tanzania in February 2014 (Refer to report in annex 8)
Relevance to EDCTP’s objectives and mission
Public health relevance to developing countries and alignment with the priorities of the EDCTP Joint Programme
In line with EDCTP’s principle of supporting research centres in the networks of excellence involved in clinical trials, EACCR facilitates collaboration in Eastern
Africa by uniting 35 diverse regional institutions with their distinctive strengths into a network for synergy and complementarity. Its members are learning and
developing ‘by doing’ how to plan jointly (instead of ‘silo’ planning), manage this initiative by consensus, share and pool limited resources equitably and jointly to
increase capacity to raise the quality of health research and practice for accelerating development of new or improved tools (vaccines, diagnostics, drugs,
microbicides and interventions). This resonates well with the set mission of EDCTP. These expected outcomes are meant to improve the health and social
advancement of the Eastern African population. The knock-on impact of EACCR will be feasible once adequate and sustainable capacity (of people, infrastructure,
governance, finance, science and technology) has been built to conduct multi-centre clinical trials and other health research under best practices with adequate
sample size requirements and networking. By networking in EACCR, meaningful partnerships (south-south, south-north and north-north) are created and
strengthened in line with this ideal principle of EDCTP. This has created the enabling environment for handling many more multi-disease clinical trials, which are
the heart of EDCTP’s business. The objectives of EACCR mentioned above address the regional challenges of inadequate research infrastructure, limited critical
mass of researchers and administrators, fragmentation and duplication of effort, competition for limited unshared resources and poor use of research evidence in
policy formulation and programming. EACCR strives to collaborate with similar initiatives e.g through Wellcome Trust (THRiVE consortium, Makerere UniversityUVRI Infection and Immunity program and Afriqueone) at institutional, country and regional level to avoid duplication of efforts, promote synergy and ensure
sustainability. In addition, EACCR seeks partnership with national disease control programs, political goodwill and financial support regional governments and the
East African Community to address mutual concerns collectively and jointly use research evidence for further interventions and higher-level advocacy. The onus is
also upon the EACCR and its stakeholders to channel successful health products developed and evaluated through policy to large-scale implementation, supported
by strengthened health systems.
SECTION B: PROJECT MANAGEMENT
Overall summary of progress on the grant during this reporting period (max 300 words)
The network continued to hold regular teleconferences and Skype calls of its governance structure below for progress review, stakeholder
consultations and consensus-building. We prepared and revised work plans and budgets for the main framework programme 6 grant, the
Coordination Support Action sub-grant and for the core support funding. The respective contracts have been amended and signed with EDCTP.
Ear-marked funds were harmoniously disbursed to the respective nodes and leading sites in accordance with the EDCTP financial guidelines. We
have implemented the required interim financial audits. EACCR has facilitated the execution of the EDCTP stepwise laboratory accreditation
programme in the 6 selected sites in partnership with the contracted LQT and the ASLM agencies. The EACCR secretariat and members have
continued to share and discuss the emerging grants and training calls/opportunities to sustain the Network activities.
EDCTP -East African Consortium for Clinical Research 5th Year report (2)
Page 8 of 25
DMS # 72347-V1

Has there been any change to the management structure since submission of the last report to EDCTP? [Yes Dr. Kayla Laserson from KEMRI CDC in
the organogram below, moved to new job. She was replaced by Mr. Steve Wandiga from the same organisation in Q3 2014
SECTION C: RESEARCH ACTIVITIES
Provide an update on the research activities that are supported by this grant. Copy and paste the table below should you wish to add additional trials, studies
or sub-studies undertaken by the Network. None at the moment!
SECTION D: CAPACITY DEVELOPMENT
Indicate how infrastructure upgrades and purchasing of capital equipment** has improved the capacity (under each section below), to
conduct future research for each collaborating site. Annex 2 provides explanation on how levels are classed.
Sample repository
Refubishment of Biorepository for more freezer space which has improved
sample storage capacity and has contributed to the initial BL accreditation
Laboratories
BL expansion provided space for level II and III Labs and Biorepository. This
has enabled organisation of the lab into specific units and biosafety levels.
Clinical trial facilities
Name of site
KCRI
Name of site
KCRI
Name of site
*Level at
baseline
*Current level
3
4
*Level at
baseline
*Current level
2
3
*Level at
baseline
*Current level
Extension of Clinical trial building at KCRI. Also purchase of equipments and
furniture
Refubishment of KCRI-Kibong’oto Research Unit
Purchase of furniture for KCRI – Kibong’oto Research Unit
KCRI
3
4
KIBONG’OTO
2
3
Data management
Name of site
*Level at baseline
*Current level
Purchase of furniture. This increased data entry spots, data management
and processing capacity
KCRI
2
3
Information technology and information sharing facilities
Name of site
*Level at baseline
*Current level
EDCTP -East African Consortium for Clinical Research 5th Year report (2)
Page 9 of 25
DMS # 72347-V1
Short-term training [eg Short courses in GCP, HSRP, GCLP, IATA etc]
Name of training
Lead Auditor Course, Qualitative culture training and ISO 15189:2007 requirements
Dates of training
Duration of training
Lead Auditor Course (22-26 July 2013) Qualitative culture training (7-20 July 2013) and ISO 15189:2007 requirements (2-5
October 2013)
Lead Auditor Course (Nairobi, Kenya) Qualitative culture training (Kampala, Uganda) and ISO 15189:2007 requirements (Nairobi,
Kenya)
SGS (Lead Auditor Course), Qualitative culture training (Makerere University, Clinical Research Center) and ISO 15189:2007
requirements (Aga Khan University)
Lead Auditor (5 days), Quantitative culture training (2 weeks) and ISO 15189:2007 (2 weeks)
Number of participants
8
Venue
Agency providing training
Gabriel
Omwalo
Male
Kenyan
Position held within the
network
TB Quality Assurance Section Head
Jeremiah
Khayumbi
Male
Kenyan
TB Lab Immunology Supervisor
KEMRI CGHR
Wlifred
Bundi
Male
Kenyan
Lab Technologist
KEMRI CGHR
KEMRI CGHR
First name
Surname
Gender
Nationality
Institutional Affiliation
(site name)
KEMRI CGHR
Shadrach
Mutuku
Male
Kenyan
Lab Technologist
Ruth
Sitati
Female
Kenyan
Lab Technologist
KEMRI CGHR
Joseph
Orure
Male
Kenyan
Lab Technologist
KEMRI CGHR
Miliket
Aytenew
Female
Ethiopian
Lab Technologist
AHRI-Ethiopian
Wondale
Mekonnen
Male
Ethiopian
Lab Technologist
AHRI-Ethiopian
Long-term training
Please report on the progress made towards the training targets of all long-term trainees within this Network
Type of training
Target number of trainees
Postdoctoral
0
Doctoral
0
EDCTP -East African Consortium for Clinical Research 5th Year report (2)
Page 10 of 25
DMS # 72347-V1
Masters
6
*Others
*Others may include candidates completing Honors, Bachelors degrees or National Diplomas
Candidate
Name
Surname
Gender
Nationality
Project Title
Institution
where registered
Supervisor
Date
Registered
Envisaged
Date of
completion
Oct-10
Oct-14
Aug-10
May-14
Oct-10
April-15
Post-Doctoral
NA
Masters
Student 1
Charles E.
Makasi
M
Tanzanian
No Research Topic since he is
pursuing Masters in Clinical
Trial
University of
London
International
Programmes/Lond
on School of
Hygiene and
Tropical
Medicine/Stewart
N/A
Student 2
Stella
Zawedde
Muyanja
F
Ugandan
Evaluating the MDR TB
Surveillance System in the
West Nile Region.
Makerere
University
Student 3
Patrick
Kazooba
M
Ugandan
Has not yet submitted the
title
University of
London
International
Programmes/
London School of
Hygiene and
Tropical Medicine
Prof. Joseph Kkonde
Lule and Dr. Sheba
Nakacubo-Ggita
Department of
Epidemiology,
School of Public
Health
Ann Tholen
EDCTP -East African Consortium for Clinical Research 5th Year report (2)
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DMS # 72347-V1
Student 4
Lydia
Student 5
Demissie
Nabacwa
F
Uganda
Befekadu
Debebe
F
Ethiopia
Student 6
James
Ngocho
M
Tanzania
Title to be submitted in April
2014
Evaluation of culture of
mycobacterium tuberculosis
on blood agar in resource
limited setting in Ethiopia
Assessment of the Clinical
presentation and
indentification of
pathogenicbacteria among
pupils with self-reported
respiratory symptoms in
Moshi municipality, Tanzania
University of
Liverpool, United
Kingdom
Kilimanjaro
Christian Medical
University College
(KCMU Co)
Kilimanjaro
Christian Medical
University College
Name to be given
April 2014
Prof. G. Kibiki, PhD
Prof. G. Kibiki, MD,
MMED, PhD
Dec-11
Dec-14
Oct-12
Oct-14
Oct-12
Oct-14
Long-term trainees: Retention of Built Capacity
For those candidates who have completed or are approaching completion of their respective long-term training, please state their future plans (i.e plans to
integrate into current Network, further studies, application for Senior Fellowship, will be leaving the NoE, seeking employment etc)
Training
Candidate
Name
Surname
Plans once degree has been completed
(i.e. MSc, PhD)
Student 1
Charles E.
Makasi
MSc.
Integrate into the current Network activities through NIMR once he completes in
October 2014
Student 2
Stella
Zawedde Muyanja
MSc.
Integrate into the current Network activities through IDI, Mulago Hospital and
disseminate study findings through conferences and publications
Student 3
Patrick
Kazooba
MSc.
Will be communicated after completing study in December 2014
Student 4
Lydia
Student 5
Demissie
Student 6
James
Student 7
Seith
Nabacwa
MSc.
Will be communicated after completing study in December 2014
MSc.
Will be communicated after completing study in October 2014
Ngocho
MSc.
Will be communicated after completing study in October 2014
Inzaule
MSc.
Take on new role as a Tutorial fellow teaching epidemiology and biostatistics at
Jaramogi Oginga Odinga University
Befekadu Debebe
Please insert additional rows as required
EDCTP -East African Consortium for Clinical Research 5th Year report (2)
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DMS # 72347-V1
Short-term training [eg Short courses in GCP, HSRP, GCLP, IATA etc]
Name of training
HIV Laboratory Techniques and Good Laboratory Practices (Refer to annex 9)
Dates of training
3rd - 14th June 2013
Venue
– Infectious Disease Institute Training Hub- Mulago Hospital
Agency providing training
Infectious Disease Institute, Mulago- Kampala, Uganda
Duration of training
2 weeks
Number of participants
One from the UVRI clinic
Name of Trainee
Sam
Surname
TWONGYEIRWE
Gender
Nationality
Male
Ugandan
Position held
UVRI Clinic (sister site)
Laboratory Assistant
Name of training
HIV Laboratory Techniques and Good Laboratory Practices (Refer to annex 10)
Dates of training
3rd - 14th June 2013
Venue
Infectious Disease Institute Training Hub- Mulago Hospital
Agency providing training
Infectious Disease Institute, Mulago Hospital- Kampala, Uganda
Duration of training
2 weeks
Number of participants
One from Masaka Hospital
Name of Trainee
Sarah
Surname
NAKIBUULE
Gender
Female
EDCTP -East African Consortium for Clinical Research 5th Year report (2)
Nationality
Ugandan
Institutional Affiliation
(site name)
Position held
Laboratory Assistant
Institutional Affiliation
(site name)
Masaka Regional Referral
Hospital (sister site)
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DMS # 72347-V1
Network-linked Senior Fellowship Projects
Does this network have links or host recipients of EDCTP-funded Senior Fellowship Training Award scheme? If yes, please provide further details. This
information remains the same for EACCR and has already been shared in the 4th year report submitted to EDCTP.
Summary of numbers of staff employed on the grant. “Same as in the 4th year report”
Site 1
Site 1-UVRI
Full-time
Part-time
Staff category
Male
Female
Male
Female
Senior staff:
2
Senior Fellows/Professors/Senior Clinicians or equivalent
Mid-career staff: Intermediate level fellows
1
(> years postdoctoral experience)/clinicians/
lecturers or equivalent
Site 2
Site 2-KCMC/KCRI
Full-time
Part-time
Male
Female
Male
Female
3
1
Doctoral and Masters students
Graduate researchers
Laboratory (Managers, technicians, assistants)
Nurses and Fieldworkers
Pharmacists
Data (Managers, IT officers and assistants)
2
1
2
Administrative staff
1
Quality Control (Managers, officers)
1
1
Finance staff
1
1
Others (ancillary i.e drivers, general assistants etc)
EDCTP -East African Consortium for Clinical Research 5th Year report (2)
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DMS # 72347-V1
Total
Staff category
Senior staff:
Senior Fellows/Professors/Senior Clinicians or equivalent
Mid-career staff: Intermediate level fellows
(> years postdoctoral experience)/clinicians/
lecturers or equivalent
4
1
4
Site 3-KEMRI WT
Full-time
Part-time
Male
Female
Male
Female
1
2
5
1
Site 4-NIMR Dar es saalam
Full-time
Part-time
Male
Female
Male
Female
1
1
1
Doctoral and Masters students
Graduate researchers
Laboratory (Managers, technicians, assistants)
Nurses and Fieldworkers
Pharmacists
1
Data (Managers, IT officers and assistants)
1
1
Administrative staff
Quality Control (Managers, officers)
1
1
1
Finance staff
2
Others (ancillary i.e drivers, general assistants etc)
Total
Please add columns for additional sites
4
1
1
2
3
3
How has the grant contributed to the professional development of ALL staff employed on the project? Yes, through in-service training and different short
courses and mentorship attachments organized.
EDCTP -East African Consortium for Clinical Research 5th Year report (2)
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DMS # 72347-V1
SECTION E: RESEARCH OUTPUT
Please list the research outputs from this research grant during the current reporting period. You may include ‘in press or published material’
How many accepted (in press or published) peer-reviewed publications (research papers or books) have been produced during this reporting
period as a result of this grant? 2 (but other publications from affiliated institutions have not been captured in this report)
Detail each publication in the following order: Author(s); Article Title; Journal Name; Year; Volume; Issue Number; Page Numbers, and confirm that EDCTP
funding has been acknowledged in all publications. Please include copies of research papers as supporting annexes.
Two peer-reviewed publications:
1. Chantler T, Cheah PY, Miiro G et al. International health research monitoring: exploring a scientific and a cooperative approach using participatory
action research. BMJ Open 2014; 4: e004104
2. Inzaule S, Otieno J, Kalyango J et al. Incidence and predictors of first line antiretroviral regimen modification in Western Kenya. PLOS One 2014; 9(4):
e93106
Please provide details of any other publications resulting from this work
Please confirm that EDCTP support has been acknowledged on each publication
Yes, I confirm that EDCTP support was acknowledged in each publication.
Conference and academic workshop presentation
Give details of oral presentations and posters of this work, confirming that EDCTP has been acknowledged
1. Prof. Kaleebu gave an oral presentation on the progress updates, SWOT analysis and the future plans of EACCR at the joint review meeting of both
TESA and EACCR in Johannesburg, South Africa, 3 rd week of July 2013. Refer to annex 11.
2. Prof. Pontiano Kaleebu, Paula Munderi and Tom Lutalo presented at the European & Developing Countries Clinical Trials Partnership (EDCTP)
Stakeholders’ Meeting on HIV held at ISCTE - University Institute of Lisbon (ISCTE-IUL) in Lisbon, Portugal, on 3-4 September 2013.
Give details of presentations to non-academic audiences
This includes feedback activities to research participants and related communities, meetings with policy makers or health care professionals, media coverage or
other related activity
The EACCR secretariat prepared a policy alert/brief for the Ugandan Minister of State for Health (Primary Health Care), Dr. Sarah Opendi, on the: contributions,
activities of EDCTP in Uganda and the region; purpose of the scheduled meeting; possible areas of engagement by the Ugandan Ministry of Health and the
challenges that the Network has experienced (annex 3). This facilitated her subsequent engagement in the high-level EDCTP meeting in Dakar, Senegal, 21st
October 2013.
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DMS # 72347-V1
Give details of any research resources or intellectual property resulting from this grant
This includes websites, software or database development, patents, product licenses or other related activity
Not applicable
SECTION F: NETWORKING
Exchange/Mentorship Schemes
Please provide an update of any exchange and mentorship schemes developed at an inter or intra-network level
Participant name
Students for examinations
Sites involved
KCMC (Tanzania) and Radboud University
(Netherlands)
Outcome of exchange
External examiners from the northern partner engaged and students’
examinations were supervised
Network Communication Plan
Please provide an update of communication at the levels indicated below
Communication Level
Update
National
Regional
Local authorities
Local community
International
Policy brief presented to the Ugandan Minister of State for Health (Primary Health Care)
Network meetings outlined in sections G and H below
NA
NA
Through 2 published articles and the EACCR website (www.eaccr.org)
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DMS # 72347-V1
SECTION G: IMPACT OF NETWORK
List other EDCTP-funded projects that are contributing or benefiting from Network of Excellence capacity
Project title
TaMoVac II Project
Project coordinator
Prof. Eligius Lyamuya
EDCTP project code
To be communicated
Contribution
Invited to
scientific sessions
on HIV vaccine
trial plans
Benefit
Shared Data unit and
back-up IT server at
NIMR-Muhimbili
SECTION H: INTER-NETWORK ACTIVITIES
Have there been any activities that involved participation/collaboration with any of the other Networks of Excellence? If yes please state the name and provide
brief details on the collaboration and state the outcomes, including all joint-publications










The HIV node coordinator and Network scientific liaison officer participated through learning observation in a Joint planning meeting of WANETAM
and CANTAM in Dakar, Senegal in June 2013 with facilitation from EDCTP so that EACCR could hold a similar joint capacity-building event with TESA
in July 2013 (Refer to photograph in annex 4)
Mrs. Emily Nyanzi, the project manager, attended an evaluation meeting of MDGs organised by the Ugandan Economic Policy and Research Centre
(EPRC) and UK Aid at Sheraton Hotel Kampala, Uganda in June 2013
The HIV node coordinator and Network scientific liaison officer was invited and attended some of the scientific presentations and the annual general
meeting of the Welcome Trust-funded THRiVE consortium (www.thrive.or.ug) in Kampala, Uganda, 10-12 July 2013
EACCR participated in and contributed to a joint planning meeting of stakeholders from EACCR and TESA in Johannesburg, South Africa in mid July
2013 (see annex 5: SAPESA report)
Prof. Kaleebu and Mr. Tom Lutalo attended and participated in the HIV stakeholders’ meeting in Lisbon, Portugal, 3 rd - 4th september 2013
Dr. Sarah Opendi attended the EDCTP High-level meeting in Dakar, Senegal on 21st October 2013 upon the invitation of EDCTP and EACCR.
The HIV node coordinator participated in a skills-sharing workshop on sexual and reproductive health organized by the Canada-Africa Prevention
Trials Network at the Infectious Disease Institute, Mulago Hospital, Uganda in December 2013 (Refer to annex 6)
Dr. Reginald Kavishe, the assistant training node coordinator, from KCMC represented EACCR at the WANETAM annual general meeting (AGM) in
Dakar, Senegal, 16-18 December 2013
Dr. Miiro, the HIV node coordinator and Network liaison officer, attended an EU-funded information dissemination workshop on the released Horizon
2020 calls hosted by the Uganda National Council for Science and Technology (UNCST) in Kampala, Uganda on 22nd January 2014 followed by
another workshop by UNCST at UVRI on the same subject in February 2014. Refer to annex 7.
Dr. Miiro attended the 11th TaMoVac meeting in Dar es Salaam, Tanzania in February 2014 (Refer to report in annex 8)
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DMS # 72347-V1
SECTION I: QUALITY ASSURANCE
List the internal and external measures that are currently in place to assess and maintain strict quality standards in all network activities
INTERNAL

Ongoing training/mentoring activities for network affiliated personnel plus supervision

Guidelines, policies, manuals and regular progress review meetings

Reciprocal clinical trial monitoring scheme

Accredited Institutional Ethics Committees

Internal financial audits
EXTERNAL

External financial audits by EDCTP and European Union

EDCTP financial guidelines
ACADEMIC PROGRAMMES

Affiliating to peer-reviewed and accredited training curricula of regional leading and northern partner academic institutions

Engaging external examiners
LABORATORY

National Health Laboratory Service - South Africa for Laboratory External Quality Asurance

UK – NEQAS, American college of pathologist accreditation

Documented and shared Standard Operating Procedures
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SECTION J: FUNDING
List any new funding that was secured during this reporting period
Funding
[cash/in-kind]
Name of Co-funding Agency
Amount*
Activities funded
Core/basic operational activities and
preparatory activities to respond to EDCTP2
calls
* Where co-funding is an ’’in-kind contribution’’, please estimate the amount in monetary value
EDCTP
Cash
Co-funding letter
attached (y/n)
n
9500 euros
Please list any joint research grants held by members of the network and joint proposals submitted by members of the network
1.
Tehminah Mustafa of Haukeland University Hospital in Norway and the EACCR TB node submitted a proposal to the Norway GLOBVAC programme in
September 2013, titled ‘Improved case detection, diagnosis and management of extrapulmonary tuberculosis in Central and East
Africa using immunohistochemistry.’ Feedback on the outcome is awaited.
2. The TB node is part of a new consortium, Cystecercosis Network of Sub-Saharan Africa (CYSTNET) together with Makerere University School of Public
Health, University of Zambia, University of Malawi, Sokoine University and other partners who have submitted a proposal for research and capacitybuilding in cystecercosis (a neglected tropical disease that sometimes causes brain infestation and convulsions in humans) in response to a call by the
German Ministry of Higher Education and Research (BMBF). The outcome will be communicated.
3. An African Research Leaders’ Award was granted to Dr. Eugene Kinyanda and the Centre for Global Mental Health at the London School of Hygiene and
Tropical Medicine to support the mental health among HIV infected Children and Adolescents in Kampala and Masaka, Uganda (CHAKA) project. The
vision of CHAKA is to generate evidence to inform the development of mental health services for children & adolescents with HIV/AIDS through
psychiatric diagnoses made.
4. UVRI, NIMR-Mwanza and KEMRI put together an application to respond to the MRC Health Systems Research "Exploring Strategies for
Empowering communities and Improving Health Services for a population of Lake Victoria Fisherfolk."
Has the Network been able to undertake any cost-saving initiatives during the current reporting period? No
Cost-saving initiatives
i.e In house lab testing as opposed to outsourcing
N/A
New activities supported
Funds reallocated to training activity i.e GCLP
Have there been any efforts to amass significant funding to ensure long-term sustainability of the Network? Yes. Please list below
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DMS # 72347-V1
Organisation
Norway GLOBVAC programme
World Health Organization, Capacity-Strengthening Programme
Germany Ministry of Higher Education and Research (BMBF)
European Union
Support Secured
Grant application submitted by the TB node and the response is awaited
$49, 104 sought was not successfully secured
1 grant application has been submitted by the TB node but another grant application by the
HIV node was not submitted because the German partner was too committed elsewhere
2 grant applications by the HIV and TB nodes to Horizon 2020 calls of December 2013 were
not submitted because the European partners to lead submission were already so engaged
to participate further
SECTION K: SOCIAL IMPACT
In the spaces provided, briefly highlight success stories and social impact made by the Network (i.e recognition/staff or trainee awards/upliftment of local
communities etc). Photographs may be included.
Success stories
Dr. Eugene Kinyanda, employed by the MRC/UVRI Uganda Research Unit on AIDS as a project leader of the mental health project and a former EDCTP senior
fellow linked to EACCR, secured a prestigious highly competitive African research leader award by the joint United Kingdom MRC/DFID scheme in partnership
with the Centre for Global Mental Health at the London School of Hygiene and Tropical Medicine. This award will provide support up to 5 years with the aim of
strengthening research leadership in Sub-Saharan Africa by attracting and retaining exceptionally talented scientists to lead high quality research programmes.
The award was granted to the Centre for Global Mental Health and Dr. Kinyanda to support the mental health among HIV infected Children and Adolescents in
Kampala and Masaka, Uganda (CHAKA) project. The vision of CHAKA is to generate evidence to inform the development of mental health services for children
& adolescents with HIV/AIDS through psychiatric diagnoses made. More detailed information is available on http://www.centreforglobalmentalhealth.org/newsevents/news/centre-awarded-mrcdfid-african-research-leader-fellowship.
Mr. Seith Chekata Inzaule, a former Master of Science student of EACCR funded by EDCTP and a former employee of KEMRI-CDC, Kisumu, Kenya completed
successfully his research work and thesis on ‘combined antiretroviral treatment switch and discontinuation among HIV infected patients’ which has been
published in an open-access peer-reviewed journal of Plos-one in 2014. His abstract was also accepted for an oral presentation in the forthcoming 7th EDCTP
forum in Berlin, Germany, 30th June-3rd July 2014. Seith has also steadily progressed to take a new employment as a tutorial fellow in the school of health
sciences at Jaramogi University, Kenya to teach epidemiology and biostatistics.
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DMS # 72347-V1
Social benefits
Dr. Charles Kabugo, a former Master of Science student of EACCR, transferred from Masaka Regional Referral Hospital (a sister site) to Mulago National Referral
Hospital to increase his contributions to the provision of high quality health services to sick clients and to the provision of medical education to students at the
quality improvent ward of the Infectious Disease Institute-Mulago (a leading site).
Another current Master of Science student of EACCR on a distance learning programme of international health management with the Liverpool School of
Hygiene and Tropical Medicine, UK, transferred from Uganda Virus Research Institute to concurrently take on new employment as an administrative assistant in
the faculty of vocational and distance education at the Makerere University Business School, Nakawa, Uganda. Ms. Lydia Nabacwa is now assisting fellow
students by handling their academic registration and orientation activities at this school; sorting their emerging academic issues or concerns; organizing faculty
and academic meetings; writing monthly report updates; facilitating release of their examination timetables; invigilating their exams; entering students’ results
on the school’s online system and supporting release of students’ testimonials.
SECTION L: FUTURE OF THE NETWORK
(To be completed by the Project Coordinator)
Briefly describe your plans for the next reporting period as well as your strategic vision to make this this Network a ’’Centre of Excellence’’ (in the context of
delivering ’’world class science’’ and ’’translating research into clinical innovation’’)
EACCR has amended and extended its contract with EDCTP up to December 2014 and has secured core support funds for the prioritized essential operational
activities in the nodes and the secretariat during this period. In this enabling context, the network will continue mobilizing its members to brain-storm, refine
and develop concrete agreed-upon research ideas/questions and follow-on capacity-building plans to be included in the different proposals targeting the
expected grant calls from EDCTP in the 3rd quarter of 2014 and other relevant emerging grants and training calls elsewhere for more funding. We shall also
contribute to generating new strategies and potential work plans for inclusion in a new EACCR 2 strategic plan. This will be achieved through joint sharing of
upcoming grant calls in email exchanges, the EACCR website and teleconferences; joint planning and grant writing; joint face-to-face meetings and networking
with the identified new partners in Rwanda, product development partners and the other networks of excellence. We shall capitalize on the optimal sidemeetings of the capacity-building workshop planned during the 7th EDCTP forum in Berlin, Germany, 30th June to 3rd July 2014.
EACCR will plan follow-on career pathways for its promising trained and existing scientists by creating or identifying further masters’ degree, doctoral and postdoctoral fellowships in the network research and capacity-building programs. We will continue to interact with the local, national and regional policy makers
plus health-related programme managers through de-briefing meetings and research-policy workshops in order to ensure that the existing research evidence
contributes to policy and practice.
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SECTION M: CHECKLIST
Have you attached supporting documents relevant for this reporting period?
Yes/No/Not Applicable
CV’s of new collaborators
Copies of scientific publications/abstracts of conference poster presentations
Copies of newsletters with articles about the Network
Photographs for activities under Capacity Building
[site upgrades and purchase of capital equipment; project team photographs for short-term training]
Participant signature lists for attendance of short-term training courses
New cofunding letters
Success stories (newsletter articles/photographs)
Ethical approval letters/letters of amendment/ latest version of the protocol
Trial Insurance certificates (only applicable to clinical trials)
Index of Trial Master File (only applicable to clinical trials)
Report from last monitoring visit (only applicable to clinical trials)
NA
Yes
No
Yes
SECTION N: DECLARATION
No
No
No
No
No
No
No
(To be completed by the Project Coordinator)
I, Professor Pontiano Kaleebu hereby declare that the information provided in this report to be correct and accurate. This report was prepared in consultation
with all node and site coordinators and is submitted on behalf of the EACCR Network
02/05/2014
Signature of Project Coordinator
EDCTP -East African Consortium for Clinical Research 5th Year report (2)
Date [DD/MM/YYYY]
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LIST OF ANNEXES
Annex
Annex
Annex
Annex
Annex
Annex
Annex
Annex
Annex
Annex
1: Chantler T et al publication in BMJ Open 2014Annex 2: Nzaule S et al publication in PLOS One 2014
3: Minister’s policy brief/alert
4: Group photograph for the joint WANETAM-CANTAM meeting in Senegal, June 2013
5: Summary report of the joint TESA-EACCR meeting in South Africa, July 2013
6: Summary update of the sexual and reproductive health workshop by CAPT Network, December 2013
7: Summary on the information workshop of EU Horizon 2020 calls held in Uganda, January 2014
8: Summary update on the TaMoVac meeting in Dar es Salaam, Tanzania, February 2014
9: Training report by laboratory assistant from the UVRI clinic
10: Training report by the laboratory assistant from Masaka Hospital
11: Power-point presentation by Prof. Kaleebu at the joint TESA-EACCR meeting in South Africa, July 2013
EDCTP -East African Consortium for Clinical Research 5th Year report (2)
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ANNEX 2:
Criteria for classification of research institutions into various levels
Level
Overall Institutional
Rating
1
Epidemiologically
relevant population and
interested investigators
2
Identified cohort and
follow-up capability
3
Sites with some clinical
trial capacity (Phase III)
4
Fully capable site for phase
I-III trials
Some access to
laboratory facilities
Ability to measure
clinical outcomes
Data collection field
staff
GCLP compliant
GCLP compliant
GCLP compliant
Access to facilities with
staff
Some computer infrastructure and basic
data-processing skills
Sample repository
Information Technology
(IT)
Absent
No internet access
Excellent facilities with
qualified staff
Biostatistics, sufficient
computer hardware and
software. Experienced data
processing staff
Available
Excellent IT facilities
established with adequate
qualified support staff
Library facilities
None
Finance and
Administration
Weak administrative
capability
Absent
Some computer
infrastructure with
limited internet access
(dial-up access)
Limited on-line
literature access
Basic administrative
capability
Investigators
Lack of GCP training
GCP exposure
Subjects
Target population
identified
Ethics
Institutional Review
Board (IRB) not yet
established
Demonstrated ability to
follow-up community
involvement
IRB and
national ethics
committee exist
Adequate facilities and
qualified staff
Sufficient computer
hardware and software.
Experienced data
processing staff
Part of laboratory
Sufficient computer
hardware and soft ware;
broad band access and
some IT support
Adequate facilities both
on-line and hard copies
Accounting and
administrative systems
available
GCP qualified with limited
experience
Demonstrated ability to
follow-upcommunity
involvement formalised
IRB and
National guidelines for
clinical trials exist
COMPONENTS
Laboratories
Clinical facilities
Data management
EDCTP -East African Consortium for Clinical Research 5th Year report (2)
Excellent facilities both online access and hard copies
Well established and audited
accounting and
administrative systems
GCP qualified with
experience
Demonstrated ability to
follow-upcommunity
development programme
IRB
National guidelines for
clinical trials exist
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