Investigational Therapy or Treatment (TRT) in FDA SEND Trial Summary Data
In the June 2026 FDA Study Data Technical Conformance Guide, TRT is the Trial Summary parameter code for Investigational Therapy or Treatment; 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.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
For FDA nonclinical SEND Trial Summary data, use TRT for Investigational Therapy or Treatment; FDA marks this parameter as desired.
Key details
Core IssueIn the June 2026 FDA Study Data Technical Conformance Guide, TRT is the Trial Summary parameter code for Investigational Therapy or Treatment; FDA lists it as desired for nonclinical Trial Summary data.
Registerscholarly, professional, or research/report writing
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, use TRT for Investigational Therapy or Treatment; FDA marks this parameter as desired.
Purpose
Represent Investigational Therapy or Treatment in the nonclinical TS dataset with parameter code TRT, 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, TRTCAS is the Trial Summary parameter code for Primary Treatment CAS Registry Number; FDA lists it as desired for nonclinical Trial Summary data. FDA notes that the CAS number may not be immediately available, especially at the opening IND submission. 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, TRTUNII is the Trial Summary parameter code for Primary Treatment Unique Ingredient Identifier; 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, TRTV is the Trial Summary parameter code for Treatment Vehicle; 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, 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.
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.
