1. Research problem
a. Background
and rationale
b. Objectives
and/or hypotheses |
-
What is the background of this investigation from the literature?
-
What is the experience of investigator(s)?
-
What is the current status of research in this field?
-
What is the purpose of the study and/or the question being asked?
|
2. Research Management
a. External review/monitoring
b. Site selection
c. Personnel
d. Trial period |
-
What will the site of the study be?
-
What facilities will be needed?
-
Are these facilities available?
-
What personnel will needed to conduct study?
-
What is the approximate time schedule for carrying out study?
|
3. Design characteristics
a. Independent variables
b. Design configuration
c. Subject assignment
d. Control of treatment-related
bias
e. Control of extraneous variables |
-
How does this design insure that the information obtained is scientifically
meaningful?
|
4. Treatment characteristics
a. Description
b. Dosage
c. Duration |
|
5. Subject characteristics
a. Selection criteria
b. Representativeness of sample
c. Subject recruitment
d. Subject compliance |
-
What is the patient population to be studied?
-
What steps will you take to insure that your sample is representative and
inclusive?
-
How will subjects be recruited and selected?
-
What are the provisions for the protection of rights and welfare of subjects?
|
6. Data collection
a. Scope of assessment
b. Assessment measures
c. Assessment schedule
d. Assessment performance |
-
What data will be collected?
-
How and when will it be collected?
|
7. Data analysis
a. Data preparation
b. Data presentation
c. Statistical analysis
d. Data synthesis |
-
What are the expected results?
-
By what means will the data be interpreted and analyzed?
|
8. Conclusions and interpretation
a. Focus
b. Logic
c. Application |
-
What will be the theoretical and/or applied implications of the results
of this study?
|
