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**ALERT:  This module has been replaced by more specific content (surgery, radiation drug therapy, etc) and the content has been archived.

Variable Name

Variable Definition

Rule

Conditionality

CDE Public ID

Intervention Start Date

The start date for the administration of the intervention.

Conditional

Required for primary endpoint intervention data and concomitant data collection (that is, drug agent or radiation therapy) that span periods of time greater than a single day (24 hours).

For interventions that are less than 24 hours, then Procedure Date combined with Start Time & Stop Time can be used instead.

3028744v1

Intervention Stop Date

The end date for the administration of the intervention.

Conditional

Required for primary endpoint intervention data and concomitant data collection (that is, drug agent or radiation exposure) that span periods of time greater than a single day (24 hours).

3028746v1

Start/Stop Date Type

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

Conditional

Required when Start and Stop Date are collected AND Intervention or concomitant data collected involves varying types of time periods (that is, period of dose delay & period of dose modification).

2867545v1

Procedure Date

The date of the evaluation, procedure or visit that yielded data.

Optional

N/A

3029079

Intervention Start Time

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

Optional

N/A

2004095v3

Intervention Stop Time

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

Optional

N/A

2004139v3

Dose

The amount that represents the dose of the intervention.

Conditional

Required for primary endpoint intervention data and concomitant data collection that involves a quantifiable dose (that is, drug agent or radiation exposure)

2182728v2

Dose Type

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

Conditional

Required when Dose is collected AND dose data includes varying types of doses (that is, planned and modified), otherwise optional.
IMPLEMENATION NOTE: This CDE can be combined (pre-filled) on a form with other CDEs to create questions such as Total Dose or Daily Dose.

2867528v1

Units of Measure

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

Conditional

Required for primary endpoint intervention data and concomitant data collected that Involves measurable units (that is, “mg” (dose), “cm” (length)).

3028750v1

Intervention Completion Status

The type of status completion, including delays or alterations in the intervention delivered.

Conditional

Required for intervention data collected that involved the study’s the primary endpoint (that is, Radiation Therapy). Optional for secondary endpoint data such (that is, Treatment history or Concomitant data).

2871593v1

Reason Intervention Not Completed or Interrupted

The reason the intervention was modified.

Conditional

Required when Intervention Completion Status is collected.

3028823v1

Reason Intervention Not Completed/ Interrupted other specify

The free text field used to describe the reason the intervention was modified.

Conditional

Required when ‘Reason Intervention Not Completed or Interrupted’ is collected AND ‘Other specify’ is included in the list of values for the study.

3028825v1

Site

Text name of an anatomic organ site (single) within the body; may be referenced in primary site of disease, surgical intervention, or extent of disease documentation.

Conditional

Required for intervention data collected that involves varying anatomic body sites (surgery or radiation therapy) AND/OR requires specification of certain location/areas within those body sites (that is, right lung lobe).

2003987v2

Other site specify

The text that describes the other specific organ system or body site.

Conditional

Required when Site is collected AND ‘Other’ is included in the list of values for the study.

2182671v1

Additional Site Description

Text description of named anatomic site(s) in the body.

Optional

N/A

2721413v1

Comments

The free text field for general notes.

Optional

N/A

797v5