ASSESSMENT OF TDR RESEARCH GRANTS (PROGRESS AND RENEWAL REQUESTS) CONFIDENTIAL 1.1 Reviewer Surname: First name(s): Committee: Venue: Date: Project title: Project ID: Number years of funding to date: Total funds transferred (US$): Document type: This form is designed to 1. Provide a critical and objective assessment of the work done in the past 12 months and inform investigators of how reports are reviewed. 2. Provide feedback to the investigator with a clear indication of the strengths and weaknesses of the document. 3. Provide recommendations to WHO on whether to continue funding, suspend or end the research project. 4. Make recommendations to guide the investigator in the subsequent stages of the project Further to carrying out best practice of independent peer review, it is especially to be noted that for research involving human subjects the WHO Ethics Review Committee (ERC) requires that all funded research projects undergo scientific and technical assessment as part of the committee's continuing ethical review process. This must be undertaken by external reviewers who are independent and not in any way involved with the design or execution of the project. Respond to each question with YES, NO or Not applicable (N/A) and provide comments using bullet points. Is project being implemented as intended? 1. Did the investigators address issues raised / deficiencies identified the last time the project was reviewed? Yes [ ] No [ ] NA [ ] 2. Has the project / protocol changed / deviated from the approved version? Yes [ ] No [ ] NA [ ] Comments on summary of progress Enter text here Goals and objectives 3. Are the objectives and/or hypothesis being tested still relevant? Comments on goals and objectives Enter text here Yes [ ] No [ ] NA [ ] Study Design and Methodology 4. Is the study being conducted as originally proposed? Yes [ ] No [ ] NA [ ] 5. Are the study objectives being addressed? Yes [ ] No [ ] NA [ ] 6. Is the original sample size achievable in the context of the study? Yes [ ] No [ ] NA [ ] 7. Is the study in compliance with the data management and analysis plan? Yes [ ] No [ ] NA [ ] Comments on study design and methodology Enter text here Participant safety and other ethical issues (this section is mandatory for clinical trials) 8. Is the study in compliance with the protocol for participation of involve human subjects (consent, recruitment, follow up, care and protection)? Yes [ ] No [ ] NA [ ] 9. Does the study require the oversight of a DSMB? Yes [ ] No [ ] NA [ ] 10 Did the DSMB meet during the period under review? Yes [ ] No [ ] NA [ ] 11. Has the project renewed their ERC approval for the following year? Yes [ ] No [ ] NA [ ] Comments on patient safety and other ethical issues Enter text here Progress of the study and expected outcomes 12. Is the study progressing according to the implementation plan? Yes [ ] No [ ] NA [ ] 13. Is a plan of work for the next 12 months provided? Yes [ ] No [ ] NA [ ] 14. Is the continuation of the project justifiable? Yes [ ] No [ ] NA [ ] Comments on progress and expected outcome. Enter text here Project team 15. Are the necessary competencies available to continue the research project? Yes [ ] No [ ] NA [ ] 16. Are the available facilities / infrastructure still adequate for the project? Yes [ ] No [ ] NA [ ] 2/4 Assessment of progress Project ID Comments on project management Enter text here Budget 17 Is a financial report provided? Yes [ ] No [ ] NA [ ] 18 Is the project being implemented within the approved budget? Yes [ ] No [ ] NA [ ] 19 Is a budget for the next phase of the work provided? Yes [ ] No [ ] NA [ ] 20 Is the budget provided realistic and well justified? Yes [ ] No [ ] NA [ ] Comments on budget Enter text here Partnerships and collaborations 21 Are new collaborations / partnerships developed in the course of the grant? Yes [ ] No [ ] NA [ ] 22 Are collaborations/partnerships outside the PI's institution delivering on their assigned roles? Yes [ ] No [ ] NA [ ] Comments on partnerships and contribution to knowledge. Enter text here Research capacity building / strengthening. (Complete this section if the application includes a capacity building component). 23 Has the project enhanced any specific area of capacity for research in the period under review? Yes [ ] No [ ] NA [ ] 24. Are the human resource development plan (skill acquisition, graduate training etc) on track? Yes [ ] No [ ] NA [ ] Comments on capacity building. Enter text here 3/4 Assessment of progress Project ID Overall score: Score each item below on a scale of 1 to 5, where 1 is the best and 5 is the worse. Projects with a score of 4 or 5 in any one category and an average score above 2.5 can not be considered for further funding. Scientific merit Continued Relevance Capacity building (if applicable): Feasibility Ethical (if applicable) Average RECOMMENDATION 25 Do you recommend continuation of this project? Yes [ ] No [ ] NA [ ] 26 Do you recommend funding at the proposed budget? Yes [ ] No [ ] NA [ ] 27 If answer to 29 is Yes and to 30 is No, please recommend a budget figure ____________________ If you do not recommend continued funding at the proposed budget, indicate your recommendation in the next section. OVERALL COMMENTS: Where there are deficiencies in the proposal / protocol, your comments should include information on how these may be addressed Enter text here 4/4 Assessment of progress Project ID