TASMANIAN SCIENTIFIC RESEARCH ADVISORY COMMITTEE
STUDY PROTOCOL PRO FORMA
Title
If a pilot study include this in the title
Aims
Clear statement with primary outcome (if relevant) identified
Hypotheses
Where relevant
Background
Succinct review of the literature providing a justification for the present study
Methods
Design
Specify which type of quantitative design, mixed methods or qualitative. Clearly define the intervention and control
groups (if relevant). For qualitative studies, include information as to framework/approach for data analysis.
Setting
Description of sites/centres where participants will be recruited
Participants
Inclusion/Exclusion
Characteristics of source population relevant to study and characteristics of persons unsuitable for study
Sample size and justification
Statistical justification for quantitative data, appropriate form of justification for pilot and qualitative studies
Recruitment
How, when, by whom
Measures
Describe, justify choice with psychometric data where relevant, attach copies of self-report/interview questions
Data Collection
How, when, by whom. A flow chart/diagram may be of use. Include information as to data collection timeframes.
Quality control and feasibility
Steps taken to ensure quality data collection and achievement of nominated sample size. Include information
regarding peer or internal review procedures (if relevant).
Data analysis
Describe variables for analysis and how they will be used in your chosen quantitative and/or qualitative analytic
strategies
References
Version 1 dated 11 October 2012