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Comment: Revised based on STRAP UI on Stage & Prod.

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Data Element

Description and Corresponding CTRP PA Data Element Where Applicable


Biomarker Name

Name of the biomarker as indicated in the Protocol document.

Biomarker Use
(CDE ID 2939411)

Value that describes the biomarker use. Valid values include:

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Marker Assay Use - Include v4.4
Marker Assay Use - Include v4.4

Biomarker Purpose
(CDE ID 2939397)

Value that describes the reason or intention of the biomarker in the clinical study. Valid values include:
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Marker Purpose - Include v4.4
Marker Purpose - Include v4.4

NCI ID

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Trial Attribute NCI ID - Include v4.4
Trial Attribute NCI ID - Include v4.4

ClinicalTrials.gov NCT ID

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Trial Attribute NCT ID - Include v4.4
Trial Attribute NCT ID - Include v4.4

Lead Org ID

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Trial Attribute Lead Org Trial ID - Include v4.4
Trial Attribute Lead Org Trial ID - Include v4.4

Phase

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Trial Attribute Phase - Include v4.4
Trial Attribute Phase - Include v4.4

Disease Site

Anatomic site terms that identify the anatomic cancer site(s) on which a trial or study is focused. For a list of values, refer to Anatomic Sites. When a trial has multiple disease sites, the report uses a semicolon (;) to separate values.

Official Title

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Trial Attribute Official Title - Include v4.4
Trial Attribute Official Title - Include v4.4

Current Trial Overall Status

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Trial Attribute Current Trial Status - Include v4.4
Trial Attribute Current Trial Status - Include v4.4

Processing Status

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Trial Attribute Current Trial Processing Status - Include v4.4
Trial Attribute Current Trial Processing Status - Include v4.4

Intervention Name

Standard name used to refer to an intervention. For drugs, this is the generic name. For investigational new drugs that do not yet have a generic name, this may be the chemical name, company code, or serial number. When a trial has multiple intervention names, the report uses a semicolon (;) to separate values.

Intervention Type

Mode of intervention, for example, drug or device. When a trial has multiple intervention types, the report uses a semicolon (;) to separate values.