Protocol Data Element Definitions

The standard will be used to describe trials that conform to: 1) Any applicable human subject or ethics review regulations (or equivalent) and 2) Any applicable regulations of the national or regional health authority (or equivalent). Most of the records in describe clinical trials (also called interventional studies). A clinical trial is a research study in which human volunteers are assigned to interventions (for example, a medical product, behavior, or procedure) based on a protocol and are then evaluated for effects on biomedical or health outcomes. also includes records describing observational studies and programs providing access to investigational drugs outside of clinical trials (expanded access).