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9. Background: (Instructions: Literature review of previous studies on the subje
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9. Background: (Instructions: Literature review of previous studies on the subject; and justification of the study by stating the problem and its importance)
10. Objectives of the Study:
10.1 Aim of the Study: (Instructions: state the goal you need to achieve)
10.2 Specific Objectives: (Instructions: state the details of each objective that will finally lead to achievement of the goal)
10.3 Secondary Objectives: (Instructions: these are subsidiary objectives that could be studied during the course of the project but are not the main objectives of the study, they are optional and vary according to the type of the study)
11. Materials and Methods: (Instructions: Describe the research methods that could best achieve the study objectives, recommend to attached flow charts)
11.1 Study Area/Setting: (Instructions: describe the area or setting where the study will be conducted. This description should cover the details relevant to the study topic)
11.2 Study Subjects: (Instructions: Inclusion and exclusion criteria of the study subjects)
11.3 Study Design: (Instructions: mention the type of study design eg cross-sectional, case- control, intervention study, etc..)
11.4 Sample Size: (Instructions: mention the input criteria for sample size estimation.)
11.5 Sampling Technique: (Instructions: mention the sampling technique, (e.g. randomization) that will be used in order to obtain a representative sample for your target population.)
11.6 Data Collection methods, instruments used, measurements (Instructions: Describe the instruments used for data collection (questionaire, observation recording from, etc.), and studied variables included in these instruments, as well as the methods used to test for the validity and reliability of the instrument. Techniques used should be briefly described and referenced. Study definitions [e.g., case definition] should be mentioned.
11.7 Data Management and Analysis Plan: (Instruction: Describe the analysis plan, tests used for data analysis and statistical package(s) used)
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