Study Director (STDIR) in FDA SEND Trial Summary Data
In the June 2026 FDA Study Data Technical Conformance Guide, STDIR is the Trial Summary parameter code for Study Director; 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 STDIR for Study Director; FDA marks this parameter as desired.
Key details
Core IssueIn the June 2026 FDA Study Data Technical Conformance Guide, STDIR is the Trial Summary parameter code for Study Director; 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 STDIR for Study Director; FDA marks this parameter as desired.
Purpose
Represent Study Director in the nonclinical TS dataset with parameter code STDIR, 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, 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, STCAT is the Trial Summary parameter code for Study Category; 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, SDESIGN is the Trial Summary parameter code for Study Design; 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, STENDTC is the Trial Summary parameter code for Study End Date; FDA lists it as conditional for nonclinical Trial Summary data (when 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, STRPSTAT is the Trial Summary parameter code for Study Report Status; 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, SSTYP is the Trial Summary parameter code for Study Type; 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.
