–  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