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10th Postgraduate Course for Training in Reproductive Medicine and Reproductive Biology

Research Protocol

M. Boulvain

This is only a suggested outline: most research agencies or ethics committees may have different guidelines, which should obviously be followed.

1.   Introduction, summary:

  • importance of the problem
  • short summary of the current state of knowledge
  • summary of the proposed research project, closing with your objectives and the rationale.

2.   Literature review

  • summary of the present knowledge on:
    the exposure
    the outcome
    the relation between exposure and outcome: systematic review
  • show how the project will improve the current knowledge:
    is this the first study?
    if not, how this study will correct biases present in previous studies, or their lack of precision

3.   Objectives (some prefer to state them before the Literature review)

  • Primary objective (or Main)
  • Secondary objective (or Subsidiary)
  • Hypothesis (optional, but it clarifies the purpose of the study to clearly state the hypothesis)

An alternative presentation could be:

  • Overall goal
  • Specific objectives 
  • Pertinent definitions (optional, but beware that the reader might not have the same as yours, thus be explicit)

4.   Relevance

Justify the importance of the study (you should convince the reader !). May be the put at the end, as a conclusion.

5.   Methodology

  • Type of study design and a short justification for choosing this design, including limitations
  • Study population (target population):
    Inclusion criteria
    Exclusion criteria
  • Study procedures 
  • Outcome measures
  • Statistical analysis
  • Sample size (computed according to the primary outcome measure)
  • Timetable

6.   Feasibility

Often critical when submitting a research project for funding. Be realistic!

7.   Ethics

Guidelines are available (CIOMS)

8.   Conclusions/Relevance

This point is also very important, as the referee must be convinced at the end of his reading of the relevance of the project.

9.   References

You must support all your statements with relevant references, preferably found in good and generally available journals. Don't miss "The" important reference, as referees are expert in your field of research.

10. Budget

Generally the format is provided by the funding agency.