Research methodology
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- Operational definitions
- Some elements of the variables to be studied:
What characteristics will be measured? How will the variables be defined? What scales of
measurement will be used etc.
Inclusion/ exclusion criteria
Sampling procedure to be used and sample size and power calculation.
Data collection and management
- Data collection and coding forms should be appended to protocol
- Training and quality control, bias control, data entry and storage, data clean-up
and correction of deficiencies
Data
analysis
- Management of dropouts
- Frequencies, rates, other parameters
- Statistical programs and tests to be used
- Data presentation (dummy tables to be appended)
Ethical considerations: rights and welfare of the subjects and method of obtaining their
informed consent
Pretest or pilot study:
(allows us to identify potential problems in the proposed study)
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