In the June 2026 FDA Study Data Technical Conformance Guide, AGETXT is the Trial Summary parameter code for Age Text; FDA lists it as “See Notes” for nonclinical Trial Summary data. FDA notes that either AGE or AGETXT should be populated, not both; use AGETXT when planned age is expressed as a range, and use AGE when an integer value is available. This is FDA submission guidance, not a universal SEND rule detached from the current FDA-supported standards and conformance guide.
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Quick answer
For FDA nonclinical SEND Trial Summary data, AGETXT represents Age Text; fda lists it as “see notes”. FDA notes that either AGE or AGETXT should be populated, not both; use AGETXT when planned age is expressed as a range, and use AGE when an integer value is available.
Key details
Core IssueIn the June 2026 FDA Study Data Technical Conformance Guide, AGETXT is the Trial Summary parameter code for Age Text; FDA lists it as “See Notes” for nonclinical Trial Summary data. FDA notes that either AGE or AGETXT should be populated, not both; use AGETXT when planned age is expressed as a range, and use AGE when an integer value is available.
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Important caveats
Scope Boundary
This page is narrowly scoped to the June 2026 FDA technical-conformance table for nonclinical Trial Summary parameters; recheck current FDA guidance and supported standards before relying on version-sensitive submission requirements.
Further guidance
Content
For FDA nonclinical SEND Trial Summary data, AGETXT represents Age Text; fda lists it as “see notes”. FDA notes that either AGE or AGETXT should be populated, not both; use AGETXT when planned age is expressed as a range, and use AGE when an integer value is available.
Purpose
Represent Age Text in the nonclinical TS dataset with parameter code AGETXT, following the applicable FDA-supported SEND implementation guide and controlled terminology.
Sources and evidence
Sources are shown with the role they play in this guide. Historical or style-sensitive claims are kept within the evidence boundary described above.
In the June 2026 FDA Study Data Technical Conformance Guide, AGEU is the Trial Summary parameter code for Age Unit; FDA lists it as desired (“Y”) for nonclinical Trial Summary data. This is FDA submission guidance, not a universal SEND rule detached from the current FDA-supported standards and conformance guide.
In the June 2026 FDA Study Data Technical Conformance Guide, ASOCSTDY is the Trial Summary parameter code for Associated Study; FDA lists it as conditional for nonclinical Trial Summary data. FDA notes: include it if applicable. This is FDA submission guidance, not a universal SEND rule detached from the current FDA-supported standards and conformance guide.
In the June 2026 FDA Study Data Technical Conformance Guide, DOSDUR is the Trial Summary parameter code for Dosing Duration; FDA lists it as desired for nonclinical Trial Summary data. The guide points readers to its dosing-duration section for additional detail. This is FDA submission guidance, not a universal SEND rule detached from the current FDA-supported standards and conformance guide.
In the June 2026 FDA Study Data Technical Conformance Guide, DOSENDTC is the Trial Summary parameter code for End Date/Time of Dose Interval; FDA lists it as desired (“Y”) for nonclinical Trial Summary data. This is FDA submission guidance, not a universal SEND rule detached from the current FDA-supported standards and conformance guide.
In the June 2026 FDA Study Data Technical Conformance Guide, EXPENDTC is the Trial Summary parameter code for Experimental End Date; FDA lists it as desired (“Y”) for nonclinical Trial Summary data. This is FDA submission guidance, not a universal SEND rule detached from the current FDA-supported standards and conformance guide.
In the June 2026 FDA Study Data Technical Conformance Guide, EXPSTDTC is the Trial Summary parameter code for Experimental Start Date; FDA lists it as desired (“Y”) for nonclinical Trial Summary data. This is FDA submission guidance, not a universal SEND rule detached from the current FDA-supported standards and conformance guide.
In the June 2026 FDA Study Data Technical Conformance Guide, GLPFL is the Trial Summary parameter code for GLP Flag; FDA lists it as desired for nonclinical Trial Summary data. This is FDA submission guidance, not a universal SEND rule detached from the current FDA-supported standards and conformance guide.
In the June 2026 FDA Study Data Technical Conformance Guide, GLPTYP is the Trial Summary parameter code for Good Laboratory Practice Type; FDA lists it as desired (“Y”) for nonclinical Trial Summary data. This is FDA submission guidance, not a universal SEND rule detached from the current FDA-supported standards and conformance guide.
