1.Purpose

The purpose of this standard operating procedure (SOP) is to describe the process for study design and sample size estimation.

2. scope

This SOP applies to:

Study design and sample size estimation for clinical studies, including pharmaceutical company sponsored clinical studies, investigator sponsored studies and epidemiology studies.

The procedures described in this SOP affect all Biostatistics and Medical personnel responsible for the development, review and/or maintenance of the study design document.

All dMed colleagues including those parties whom dMed contracted to perform described activities.