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 |
