Field Epidemiology Manual Wiki

Checklist for study protocols

Last modified at 6/18/2014 9:17 AM by yvan.hutin

10-point checklist for self or peer assessment

1. Rationale of the study

1.a. The topic is of documented local public health importance (i.e., high burden, intervention available, local awareness)

1.b. The introduction logically introduces a need for new information through a research question

1.c. The information generated by the study will allow more effective prevention and control

1.d. The introduction section is short (i.e., does not exceed 20% of the document)

2. Study objectives

2.a. The objectives are focused

2.b. The objectives leave aside the expected benefit (referred to in the introduction or a specific paragraph at the end)

2.c. The objectives are clear

2.d. The objectives make use of one verb each

2.e. The objectives are clearly about measurement (i.e., "estimate") or hypothesis testing (i.e., "determine", "identify")

3. Study population

3.a. Clear, precise time, place and person inclusion and / or exclusion criteria define the study population

3.b. The study population is relevant to answer the research question

3.c. The study population is defined independently from the sampling methods that will be used to approach it

4. Study design

4.a. The study design will allow addressing the study objectives to bring an answer to the proposed research question

5. Operational definitions

5.a. The operational definitions are clear, precise and explicit

5.b. The operational definitions are based upon (1) standardized internationally accepted criteria or (2) explained rationale

6. Study sample

6.a. The sample will allow statistical inference (i.e., representative of the population, avoiding convenience/ purposive methods)

6.b. The parameters used for the sample size calculation are explicit and justified

6.c. The sample is of a size that is sufficient to generate the statistical power needed

7. Data collection

7.a. The protocol specifies the broad categories of information elements that will be collected

7.b. The protocol specifies who will collect the data

7.c. The protocol specifies how the data will be collected (i.e., tool, data collection method)

7.d. The data collection instruments are provided in the appendix

8. Analysis plan

8.a. The protocol outlines the how the data analysis will address each of the study objectives

8.b. Appropriate dummy tables in the appendix documents the planned data analysis procedure

9. Quality assurance

9.a. The protocol was peer reviewed

9.b. Quality assurance measures are planned for data collection (e.g., pilot-testing, back-translation) and data analysis

9.c. The potential bias that could affect the study are raised and discussed

10. Human subject protection

10.a. Potential risks are listed with a plan to minimize them (including confidentiality)

10.b. Potential benefits are identified with a plan to maximize them

10.c. The appendix contains a form to collect informed consent from study participants

10.d. Clearance will be sought from an ethical committee