Developing a Protocol

The quality of science is often improved when study objectives and methods are clearly thought through and described. A written protocol facilitates high quality science and is an invaluable tool to investigators as they develop and conduct studies.

Regardless of the scientific discipline in which the study is undertaken, the same scientific method is used. Further, while the scientific content will differ across studies, the general elements of the study protocol will be similar.

The Excellence in Science committee at the Centers for Disease Control and Prevention (CDC) has developed a general protocol checklist and companion guide to assist scientists in preparing protocols. The checklist is intended as an aid in suggesting a format for writing protocols and in identifying issues that scientists should consider as they design the study. The checklist was developed to have utility in conducting laboratory and basic science studies, epidemiologic studies, and behavioral and social science studies employing a variety of study designs.

In using the checklist, investigators should select the items that apply to their types of studies. It is unlikely that any protocol would include every item on the checklist.

General protocol checklist

This checklist is intended as an aid in suggesting a format for writing protocols and in identifying issues that scientists should consider as they design a study or surveillance system. When using the checklist, investigators should select the items that apply to their specific project. It is not expected that every item on the checklist is applicable to each protocol for a study or surveillance system.