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Data Element Preferred Question Text

Data Element Preferred Definition

Data Element Public ID

Data Element Version

Route

A text code or name to represent an access route for the administration of agents or substances.

2003586

6

Formulation

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

2179618

1

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.

10

4

Agent Code

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

2867247

1

indication

The reason for administration of a concomitant (nonstudy) agent or measure. This is not the pharmacologic classification of an agent (antibiotic, analgesic, etc.), but the reason for its administration to the patient. [CommonProjects:Manually-curated]

2003870

4

Ingredient

The name that describes a compound, or is a component part of any combination or mixture; an element; a constituent.

2871652

1

Frequency

The frequency schedule used for administration of agents.

2003322

4

From the FORM:

Variable Name

Variable Definition

Rule

Conditionality

PublicID

Version

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

 

10

4.0

Start date

the start date for the administration of the agent.

Mandatory

 

12

3.0

Stop date

the end date for the administration of the agent.

Mandatory

 

14

4.0

Comments

the free text field for general notes.

Optional

 

797

5.0

Frequency

The frequency schedule used for administration of agents.

Mandatory

 

2003322

4.0

Route

A text code or name to represent an access route for the administration of agents or substances.

Mandatory

 

2003586

6.0

indication

The reason for administration of a concomitant (nonstudy) agent or measure. This is not the pharmacologic classification of an agent (antibiotic, analgesic, etc.), but the reason for its administration to the patient. [CommonProjects:Manually-curated]

Mandatory

 

2003870

4.0

Start Time

The start time for the administration of an intervention, using a 24-hour clock time.

Optional

 

2004095

3.0

Stop Time

The stop time for the administration of an intervention.

Optional

 

2004139

3.0

Formulation

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

Optional

 

2179618

1.0

Dose

The amount that represents the dose of the agent.

Mandatory

 

2182728

2.0

Unit

A code system intended to include all units of measures being contemporarily used in international science, engineering, and business.  Its purpose is to facilitate unambiguous electronic communication of quantities together with their units.

Mandatory

 

2789683

1.0

Agent Code

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

Optional

 

2867247

1.0

Dose Type

A modifier to dose field to describe the kind of dose being collected.

Optional

 

2867528

1.0

Start/Stop Date Type

A modifier to date and/or time field to describe the kind of start/stop date/time range being collected.

Optional

 

2867545

1.0

Ingredient

The name that describes a compound, or is a component part of any combination or mixture; an element; a constituent.

Optional

 

2871652

1.0

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