EDCTP Integrated Project Work Plan

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1 EDCTP Integrated Project Work Plan Project Coordinator: (including contact details) Prof Keertan Dheda Tel: , Fax: , moile: (0) or Project Manager: (including contact details) Dr Grant Theron Tel.: Fax: Acronym: Project title: TB-NEAT Evaluation of multiple novel and emerging technologies for TB diagnosis, in smear-negative and HIV-infected persons, in high urden countries (the TB-NEAT study) Project code: Project start and end date: (From DD/MM/YY to DD/MM/YY) Medical sponsor: (including contact details) Clinical research / independent monitor: (if applicale) 01/06/10 to 31/05/13 Prof Greg Hussey Director of UCT IIDM Tel: (021) Fax No: (021) address: Gregory.Hussey@uct.ac.za N/A IP Work Plan form May 2008 #22200 Page 1 of 11

2 (Please complete the form electronically using the font verdana & font size 8) Work column y your performed & period covered y this work plan; see example elow) collaorators in Q1/2/3/4; see example elow) Anticipated start date in April 2010 (eginning of ) 1. Project management: 1. Contract preparations 1.1 Signed contract and EDCTP All activities funded y EDCTP / memer states 2. Management of the project at institutional, regional and international levels a a Organogram in appendix A 2.1 Site managers appointed 2.2 Formation of the Project Management Committee 2.3 Preparation and dissemination of SOP s, contractual and financial arrangements 2.4 Preparation of the Project We 2.5 Quarterly reports as applicale 2.6 Annual and final financial reports 2.7 Management teleconferences (quarterly) Intellectual propertyrelated discussions Dissemination plan 2.8 Site visits (6-monthly with more in first year) 2.9 Annual meetings 2.10 Mid term Review regarding management milestones eing achieved 2.11 End of project evaluation All s All s All s,4,4,4 Q1,2,3,4 Q1,2,3,4 Q1,2,3,4 Q1,2,3,4 IP Work Plan form May 2008 #22200 Page 2 of 11

3 Work column y your performed & period covered y this work plan; see example elow) collaorators in Q1/2/3/4; see example elow) Anticipated start date in April 2010 (eginning of ) 3. Su-contracting activities: - RU sucontracted work to UCT LI - UCT sucontracted work to McGill G 2. Clinical trial: 1. Protocol development & finalisation - All s 2. Patient recruitment 2.1 Six hundred patients recruited y A-D and A-D Q1-4 Q1-4 Q1,2 3. Data management strategy 3.1 Development of case record forms (CRF) and data collection tools All s 3.2 Data collection including the creation of functional data entry systems and A-D Q1,2 3.3 Data analysis (including interim analysis targets) report and A-D Q1,2,4 Q1,2 3.4 Data monitoring review and A-D 4. Ethics 4.1 Ethical standards review report B IP Work Plan form May 2008 #22200 Page 3 of 11

4 Work column y your performed & period covered y this work plan; see example elow) collaorators in Q1/2/3/4; see example elow) Anticipated start date in April 2010 (eginning of ) 5. Site visits 5.1 Monitoring of clinical activities,4 6. Dissemination activities 6.1 Conferences, workshops, astracts, pulications etc. All partners Q1-4 Q Capacity uilding: 1. Long-term training (supervisors are PIs): 1.1 MSc (with 6 monthly reports): - Cuthert Musarurwa - Jenny Allen 1.2 PhD (with 6 monthly reports): - Hojoon Soon, - Duncan Chanda - Richard van Zyl Smit - Jonny Peter - Shaieda Adams - TBC C E and B 2. Infrastructure upgrades 2.1 New and expanded laoratory physical structures - De Noon, Brooklyn chest clinics (or alternatives) - Meya D 3. Staff recruitment complete All s,3 4. Workshops 4.1 A detailed list of training to e held at each and the expected date of completion may e found in Appendix All s IP Work Plan form May 2008 #22200 Page 4 of 11

5 Work column y your performed & period covered y this work plan; see example elow) collaorators in Q1/2/3/4; see example elow) Anticipated start date in April 2010 (eginning of ) C. 5. GCP/GLP training 5.1 Accreditation received and participants trained D,4 6. Annual and final cap dev report Cocoordinating 7. Pulished outputs 7.1 Report summarising recent pulication outputs in terms of journal papers, astracts, conference presentations, including those to Policy Makers C 4. Networking: 1. Estalishing linkages etween other grants 1. TB-NEAT representatives attending other grants workshop (TESA, TBsusgent, ADAT, TB trna, CAD4TB) All s 2. Exchange visits etween partner s 2.1 For example: Duncan Chanda from Zamia will visit UCT for training. Others TBC. 3. Mentorship (UCL, LMU, MTC-KI and RU) will all take part in this programme. 3.1 Selected students from African s will travel to UCT and Northern partners for training and mentorship (TBC at management meetings) IP Work Plan form May 2008 #22200 Page 5 of 11

6 Work column y your performed & period covered y this work plan; see example elow) 4. Communication plan 4.1 Report dealing dissemination and communication of info collaorators in Q1/2/3/4; see example elow) Anticipated start date in April 2010 (eginning of ) 5. c : c Please note that EDCTP would treat this as purely supplementary funding and not in any way to replace or reduce EDCTP funding agreed at the signing of the contract. (EDCTP encourages leverage of third party funding to enhance synergy) 5.1 Cash co-funding 5.2 In-kind co-funding In addition to the cash funding provided directly from the EDCTP, the following memer states are providing confirmed in-kind cash funding. MRC UK (E500K) SIDA Sweden (E800K) NACCAP Netherlands (E500K) Additionally, the German BMBF is contriuted E250K directly to Partner H Networked grants and pulicprivate partnerships (FIND) represent a major source of inkind co-funding. The sources and amounts are indicated elow: FIND Switzerland (E2 million) CAD4TB Netherlands (E300K) TB TRDNA UK (E150K) TESA South Africa (E150K) ADAT Zamia (150K) IP Work Plan form May 2008 #22200 Page 6 of 11

7 Work column y your performed & period covered y this work plan; see example elow) collaorators in Q1/2/3/4; see example elow) Anticipated start date in April 2010 (eginning of ) Please note that the following documents should accompany this work plan when availale: The final study protocol(s) as approved y the sponsor and as sumitted to the ethics committee(s) (NEC). Please provide a copy of the sumission letter to the NEC(s). The study protocol(s) as approved y the ethics committee(s) and signed y the Project Coordinator and Sponsor, including a copy of the informed consent form*; Any Ethical Review Board approvals Any approvals y local authorities needed for the conduct of the clinical trials Clinical trial registry / Clinical Protocol registration Cofunding documents; any new letters confirming the amount contriuted to the project from 3rd parties or Memer States. Any other documents you wish to include. *Please note that the informed consent forms are NOT assessed y EDCTP, ut requested for the project file records. Documents that have already een sent as annex to the application form do not have to e send again, ut can in stead just e referred to. IP Work Plan form May 2008 #22200 Page 7 of 11

8 Signature of project coordinator Date 10 May 2010 Keertan Dheda Signature of work package1 leader (Project / Financial Manager) Date 10 May 2010 Grant Theron Signature of work package 2 leader (Principal Investigator) Date 10 May 2010 Keertan Dheda Signature of work package 3 leader Date 10 May 2010 Peter Mwaa Signature of work package 4 leader Date 10 May 2010 Lynn S. Zijenah IP Work Plan form May 2008 #22200 Page 8 of 11

9 Appendix A Figure A1. Overview of the project management of the TB NEAT project. The PI will chair the management committee, however, management will e co-led y all partners through shared decision making y regular meetings of the management committee. Networking activities will e led y Zimawe, capacity development activities will e led y Tanzania, and UNZA will oversee the appointment and functioning of the Ethics and Data monitoring committees. Progress of activities and milestones will e monitored through several mechanisms to ensure timely and efficient progress of the envisaged work-plan. IP Work Plan form May 2008 #22200 Page 9 of 11

10 collaorators IP Work Plan form May 2008 #22200 Page 10 of 11

11 Appendix C Workshops to e held Work shops Advanced Project management and All partners Delivery date Short courses (1 Courses and general organising clinical trials Cost-effectiveness analysis and All partners 2011 week) Day updates manageme nt training decision analysis Clinical Epidemiology, A, F-J 2012 (1 day) Ethics, F 2010/11 Local + Statistics & data management, F-J 2011 regional (2 weeks) including systematic reviews and meta-analyses Specialist technical training, F-J 2010/11/12/13 Basic Good clinical practice (GCP) All partners 2010 courses Good laoratory practice (GLP) All partners 2010 including Laoratory techniques, F-J 2011 field work Conducting clinical trials All partners 2011 and Scientific writing and presentation All partners 2012 laoratory Communication/dissemination inator 2012 training Data collection/entry inator 2012 X-ray scoring- CRRS inator 2010 Learning visits All partners 2011 Courses may e repeated as necessary IP Work Plan form May 2008 #22200 Page 11 of 11

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