Checklist for study protocols

10-point checklist for self or peer assessment:

1. Rationale of the study
   • The topic is of documented local public health importance (i.e., high burden, intervention available, local awareness)
   • The introduction logically introduces a need for new information through a research question
   • The information generated by the study will allow more effective prevention and control
   • The introduction section is short (i.e., does not exceed 20% of the document)
2. Study objectives
   • The objectives are focused
   • The objectives leave aside the expected benefit (referred to in the introduction or a specific paragraph at the end)
   • The objectives are clear
   • The objectives make use of one verb each
   • The objectives are clearly about measurement (i.e., "estimate") or hypothesis testing (i.e., "determine", "identify")
3. Study population
   • Clear, precise time, place and person inclusion and / or exclusion criteria define the study population
   • The study population is relevant to answer the research question
   • The study population is defined independently from the sampling methods that will be used to approach it
4. Study design
   • The study design will allow addressing the study objectives to bring an answer to the proposed research question
5. Operational definitions
   • The operational definitions are clear, precise and explicit
   • The operational definitions are based upon (1) standardized internationally accepted criteria or (2) explained rationale
6. Study sample
   • The sample will allow statistical inference (i.e., representative of the population, avoiding convenience/ purposive methods)
   • The parameters used for the sample size calculation are explicit and justified
   • The sample is of a size that is sufficient to generate the statistical power needed
7. Data collection
   • The protocol specifies the broad categories of information elements that will be collected
   • The protocol specifies who will collect the data
   • The protocol specifies how the data will be collected (i.e., tool, data collection method)
   • The data collection instruments are provided in the appendix
8. Analysis plan
   • The protocol outlines the how the data analysis will address each of the study objectives
   • Appropriate dummy tables in the appendix documents the planned data analysis procedure
9. Quality assurance
   • The protocol was peer reviewed
   • Quality assurance measures are planned for data collection (e.g., pilot-testing, back-translation) and data analysis
   • The potential bias that could affect the study are raised and discussed
10. Human subject protection
    • Potential risks are listed with a plan to minimize them (including confidentiality)
    • Potential benefits are identified with a plan to maximize them
    • The appendix contains a form to collect informed consent from study participants
    • Clearance will be sought from an ethical committee

FEM PAGE CONTRIBUTORS 2007

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