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.
A formal written agreement with the Office for Human Research Protections on behalf of the Secretary of DHHS and an institution which has multiple project assurance and conducts a DHHS-sponsored research project. The SPA specifies how the institution will implement the DHHS regulations at 45 CFR 46.
An organization or individual who assumes legal responsibilities for supervising or overseeing clinical trials with investigational agents
The scientific chair of a SWOG study responsible for developing and monitoring the study as well as analyzing, reporting, and publishing its results