A research protocol should provide information about the statistical considerations that are posed as questions below.

  1. What are the research aims of this study?
  2. What are the details and key features of the study design ?
  3. For what variables will measurements be recorded?
  4. What are the details of your plans for statistical analysis of the data?
  5. What statistical methods will be used?
  6. Who will perform and interpret the statistical computations for data analyses?
  7. What were the primary considerations in choosing the proposed sample size?
  8. What are the plans for data entry, quality assurance and research database management?
  9. How likely is it that the study will achieve each of its aims?

Biostatistical online educational resources

Hypothesis Testing and Sample Size Calculation
A PowerPoint presentation by Po Chyou, Ph.D., Director of MCRI Biostatics and Bioinformatics Core. The presentation presents basic considerations for statistical analysis planning in a research study. Click here to open the presentation.

Basics of Epidemiology
A PowerPoint adapted with permission from a class presentation developed by Dr. Charles Lynch – University of Iowa, Iowa City. Click here to open the presentation.

A Guide to Research Methods - State University of New York (SUNY), Health Science Center at Brooklyn provides this resource which contains a number of tables showing various types of research methodology.

Clinical Epidemiology and Evidence-Based Medicine Glossary: Clinical Study Design and Methods Terminology - Link to an article by John Gay, DVM PhD DACVPM describing various study designs and methodology.