NIH | National Cancer Institute | NCI Wiki  

Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
Comment: Migrated to Confluence 5.3
Column
width50%
Include Page
CRF Quick Links
CRF Quick Links

**ALERT:  This module has been replaced by more specific content (drug administration module) and the content has been archived.

Variable Name

Variable Definition

Rule

Conditionality

CDE Public ID

Agent Name

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.

Mandatory

N/A

10v4

Agent Code

The NCI's Enterprise Vocabulary (EVS) identification number.

Mandatory

N/A

2867247v1

Formulation

The text that describes the formulation of the agent used in the study.

Conditional

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.

2179618v1

Frequency

The description of the therapy schedule.

Optional

N/A

2003322v3

Route

A  text code or name to represent an access route for the administration of agents, evaluation of vital signs, etc.

Optional

N/A

2003586v6

Dispense Date

The date the agent was given to the participant.

Mandatory

N/A

2867515v1

Date Study Agent Returned

The date the remaining agent was returned by the participant.

Mandatory

N/A

2871611v1

Reason for Non-Compliance

The text that describes the reason the participant was noncompliant.

Optional

N/A

2182832v1