For SEND laboratory data without published controlled terminology, FDA’s June 2026 guide says LBTESTCD values must follow the SENDIG constraints: no more than eight characters, not starting with a number, and using only letters, numbers, and underscores.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
For SEND LBTESTCD values lacking published controlled terminology, follow the current SENDIG/FDA constraints on length, first character, and permitted characters.
Key details
Core IssueFor SEND laboratory data without published controlled terminology, FDA’s June 2026 guide says LBTESTCD values must follow the SENDIG constraints: no more than eight characters, not starting with a number, and using only letters, numbers, and underscores.
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
This is current FDA technical-conformance guidance for electronic study-data submissions; recheck the current FDA guide, supported standards, Data Standards Catalog, and eCTD specifications before relying on version-sensitive requirements.
Further guidance
Content
This is a SEND laboratory-code requirement, not a universal rule for every numeric or coded value in FDA study data.
Purpose
For SEND LBTESTCD values lacking published controlled terminology, follow the current SENDIG/FDA constraints on length, first character, and permitted characters.
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.
FDA’s June 2026 guide separates categorical noncontinuous laboratory results from numeric continuous results by using LBSTRESC, leaving LBSTRESN null, and documenting the categorical scale in the nSDRG.
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.
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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.
