– TITLE
– INVESTIGATORS & INSTITUTIONAL AFFILIATION
– ABSTRACT
– BACKGROUND/LITERATURE REVIEW
– JUSTIFICATION/RATIONALE
– HYPOTHESIS
– OBJECTIVES
Broad Objectives
Specific Objectives
– MATERIAL AND METHODS
Study Design
Study Site
Study population – Inclusion Criteria
– Exclusion Criteria
Data collection methods and Sampling Procedures
Data management and analysis
– TIME FRAME (TIMELINE)
Pilot Study
Definitive Study
Report Preparation
– ETHICS CONSIDERATIONS
Risks
Benefits to the subjects
Informed consent
Confidentiality
– STUDY IMPLICATIONS
– REFERENCES
– ESTIMATED BUDGET
– SIGNATURES OF INVESTIGATORS
– APPENDICES
Role of each investigator
Memorandum of understanding/contractual agreement between collaborating Institutions/Organizations
Questionnaires
Consent forms
Other relevant documents