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:
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.
3. Budget and funding
5. Investigators: Roles and responsibilities