Scientific Review Criteria

Part A – Background and Significance

1. Is the research innovative?
2. Does this study address a problem of scientific and/or practical importance?
3. Does the protocol define the underlying basic research?
4. Does the protocol explain how the project will be a significant addition to the body of knowledge?
5. Is there a clearly stated hypothesis? If not, what is the rationale for the research?
6. Is the primary objective of the research clearly stated? If yes, summarize it here (or indicate location in the protocol)?
7. Are the number of objectives reasonable such that the scope of research is appropriate?
   

Part B – Rationale/Approach & Design 

1. Are the research procedures adequately defined and are they valid?
2. Does the strength of the scientific design and methodology support the research?
3. Do the endpoints (i.e. methods, data collection) match the objectives?
4. Are adequate measures described in the protocol to minimize investigator bias?
5. Are there appropriate references or SOPs to ensure that research assays will generate valid data?
6. Is the investigator’s evaluation of the relevant literature or discussion of previous studies (if available) thorough and accurate?
7. Are the proposed methods and assays appropriate for the research? What are they (or indicate location in the protocol)?
8. Is a statistical/data analysis plan included in the protocol or appendices? Summarize it here or indicate its location in protocol)? 
9. Is the statistical/data analysis plan reasonable and detailed (when appropriate)?
10. Does the statistical/data analysis plan include appropriate statistical tests?
11. Are the conceptual framework, design, methods and analyses adequately developed, well-integrated and appropriate to the aims for the study?
12. Does the investigator acknowledge potential problem areas and consider alternative tactics?
13. Is the statistical/data analysis plan consistent with the study objectives?
14. What is the rationale for the proposed number of subjects (or indicate location in protocol)?
15. Where appropriate, are there details to explain how missing data will be addressed?
16. Will medical trainees (medical students, residents, fellows, PAs) be conducting the research?
    1. If yes, is there a mentorship plan?
    2. Is the mentorship plan adequate?

Part C – Investigator

1. Is the investigator appropriately trained to conduct this study?
2. Is the work proposed appropriate to the experience level of the principal investigator and associates?

Part D – Environnent

1. Does the scientific environment in which the study will be done contribute to the probability of success?
2. Does the proposed study take advantage of the unique features of the scientific environment or employ useful collaborative arrangements?
3. Are the facilities appropriate?