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5. PRINCIPAL INVESTIGATOR’S DEPARTMENT APPROVAL
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| Name of Head/Chairperson |
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6.Background, Preliminary Literature Review and Significance of the Study: (Write no more than 3 concise paragraphs. Give the background and context of the research, provide justification of undertaking this study – both scientific and personal, write the literature review of previous studies – use the latest references whenever possible, what is already known about the problem, what will this study contribute to the knowledge?)
7. Aims of the Study:
7.1 Research Questions / Hypotheses:
7.2 Objectives: ( objective must be SMART)
8. Materials and Methods:
8.1.Study Area/Setting:
8.2.Inclusion & Exclusion Criteria
8.3.Study Design: (Mention the type of study design e.g., cross-sectional, case-control, intervention study, etc, mention the usefulness/advantages and weaknesses of the design that you have chosen for your study)
8.4.Sample Size: (Mention the input criteria for sample size estimation)
8.5.Sampling Technique: (Mention the sampling technique, (e.g. randomisation) that will be used in order to obtain a representative sample for your target population)
8.6.Study Primary Outcomes: (Write your 2-3 main outcomes)
8.7.Data Collection Methods, Data Instruments/Questionnaires used, Measurements:
(Describe the instruments used for data collection (questionaire, observation recording form, etc.), and the 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. What are the variables of most interest? Who will collect the data? How will the data be recorded?)
8.8.Data Management and Analysis Plan: (Describe the analysis plan, tests used for data analysis and statistical package(s) used)
9. Ethical Considerations: Have you attachedInformed Consent and Patient Information Leaflet.Translated forms are to be provided when needed)Yes/No
10.Bibliographic References: (Mention recent articles relevant to the study subject and enumerated accroding to their order of appearance in the text)
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