Glossary

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SAE/SERIOUS ADVERSE EVENT

Formerly called ADR, a Serious Adverse Event (SAE) is a serious, fatal, or life-threatening clinical experience in a patient which is thought to be drug related. Specific guidelines for definitions and reporting requirements are shown in Section 16 of each SWOG protocol.

SDMC

Statistics and Data Management Center

SELECT

Selenium and Vitamin E Cancer Prevention Trial (S0000)

SPONSOR

An organization or individual who assumes legal responsibilities for supervising or overseeing clinical trials with investigational agents

STUDY CHAIR

The scientific chair of a SWOG study responsible for developing and monitoring the study as well as analyzing, reporting, and publishing its results

STUDY STATISTICIAN

The statistics and data management coordinator who develops statistical considerations for trials, then analyzes patient/study data throughout and after a study