Difference between revisions of "Checklist for study protocols"

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10-point checklist for self or peer assessment:
  
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# Rationale of the study
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#* The topic is of documented local public health importance (i.e., high burden, intervention available, local awareness)
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#* The introduction logically introduces a need for new information through a research question
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#* The information generated by the study will allow more effective prevention and control
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#* The introduction section is short (i.e., does not exceed 20% of the document)
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# Study objectives
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#* The objectives are focused
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#* The objectives leave aside the expected benefit (referred to in the introduction or a specific paragraph at the end)
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#* The objectives are clear
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#* The objectives make use of one verb each
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#* The objectives are clearly about measurement (i.e., "estimate") or hypothesis testing (i.e., "determine", "identify")
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# Study population
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#* Clear, precise time, place and person inclusion and / or exclusion criteria define the study population
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#* The study population is relevant to answer the research question
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#* The study population is defined independently from the sampling methods that will be used to approach it
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# Study design
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#* The study design will allow addressing the study objectives to bring an answer to the proposed research question
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# Operational definitions
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#* The operational definitions are clear, precise and explicit
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#* The operational definitions are based upon (1) standardized internationally accepted criteria or (2) explained rationale
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# Study sample
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#* The sample will allow statistical inference (i.e., representative of the population, avoiding convenience/ purposive methods)
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#* The parameters used for the sample size calculation are explicit and justified
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#* The sample is of a size that is sufficient to generate the statistical power needed
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# Data collection
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#* The protocol specifies the broad categories of information elements that will be collected
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#* The protocol specifies who will collect the data
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#* The protocol specifies how the data will be collected (i.e., tool, data collection method)
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#* The data collection instruments are provided in the appendix
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# Analysis plan
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#* The protocol outlines the how the data analysis will address each of the study objectives
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#* Appropriate dummy tables in the appendix documents the planned data analysis procedure
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# Quality assurance
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#* The protocol was peer reviewed
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#* Quality assurance measures are planned for data collection (e.g., pilot-testing, back-translation) and data analysis
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#* The potential bias that could affect the study are raised and discussed
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# Human subject protection
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#* Potential risks are listed with a plan to minimize them (including confidentiality)
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#* Potential benefits are identified with a plan to maximize them
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#* The appendix contains a form to collect informed consent from study participants
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#* Clearance will be sought from an ethical committee
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<div style="display: inline-block; width: 25%; vertical-align: top; border: 1px solid #000; background-color: #d7effc; padding: 10px; margin: 5px;">
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'''FEM PAGE CONTRIBUTORS 2007'''
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;Contributor
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:yvan.hutin
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</div>
  
 
[[Category:Writing a Study Protocol]]
 
[[Category:Writing a Study Protocol]]

Latest revision as of 18:38, 10 April 2023

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

Contributor
yvan.hutin
Retrieved from "https://femwiki.org/index.php?title=Checklist_for_study_protocols&oldid=1605"

Contributors