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Format and Elements of a Research Protocol

Format and Elements of a Research Protocol

One of the first steps in a research process is to develop a research protocol that includes relevant information on the planned research. As an example, the format of a research protocol of MSF (2010: 47) is presented below:

Format and Elements of a Research Protocol:

1.  Abstract

2.  Study Description

  • General information: Country and study site; Study title; Collaborating institutions, individuals and affiliations.
  • Study questions
  • Study Objectives
  • Methods: Design; Settings and sites, Study period; n; Study population; Inclusion and exclusion criteria; Study procedures; Data collection and recording; Primary outcome measures; Secondary outcome measures; Statistical analysis; Sample size calculation
  • Ethics Considerations
  • Significance or expected impact: Implications of the research for national policy and practice; Feedback and dissemination of findings.
  • References

3.     Budget and funding

4.     Time-line

5.     Investigators: Roles and responsibilities