CDE Public ID
A text name for an Agent. An agent is a distinct substance or ingredient or compound/product/mixture thereof, contained in drugs, biologics, foods, and devices that act to produce a specific effect (commonly health related). This can include radiopharmaceutical, nutritional, complimentary and alternative medicine (CAM), molecular components of devices (i.e. silicon in implants) and nano-technologic agents but does not include whole devices (implants), or procedures (i.e. surgeries). Individual agents included in a treatment regimen or therapy is included in this definition, however, whole regimen names or other broad classification of therapies (i.e. "CHOP", "chemotherapy", etc), are not.
The NCI's Enterprise Vocabulary (EVS) identification number.
The text that describes the formulation of the agent used in the study.
When CDEs for Dose type and Dose are used to display 'Amount dispensed' or 'Amount consumed', and other variations to track accountability, they must be coupled with CDEs for either Formulation or Unit.
The description of the therapy schedule.
A text code or name to represent an access route for the administration of agents, evaluation of vital signs, etc.
The date the agent was given to the participant.
Date Study Agent Returned
The date the remaining agent was returned by the participant.
Reason for Non-Compliance
The text that describes the reason the participant was noncompliant.