Clinical and Regulatory Submission Biostatistical Display

Graphs communicate. There is both an art and a science to the accurate and appropriate choice of clinical and regulatory submission visual display of biostatistical display.

The Purpose of Graphs

A good graph will:

• save the user time - information is sifted and refined
• gain user attention - easy and pleasing to the eye to generate reader motivation
• show relationships and permit study of the data
• the user should be able to look for regularities and irregularities with in the data
• study data points and their spatial relationships to each other may reveal meanings not otherwise observed
• in deciding whether to use a chart or a graph - the form which best shows the relationships should be used
• suggest new ideas - a good graph might reveal connection that otherwise would not be perceived
• make efficient use of information - display fundamental relationships by way of visual convention.

Three things will happen with a good graph:

1. the graph will be studied
2. the graph will be accepted
3. the graph will be remembered.

Remember, clinical and regulatory submission data points are the building blocks of a graph and as such a QC (SOP) procedure must be developed and utilized to ensure accuracy in data entry, programmatic presentation and graphics. Graphs are most often "double" program validated first, followed by a second, final data QC step.