PC Domain Time-Series Requirements in FDA SEND Study Data
FDA’s June 2026 guide describes PC-domain timing/grouping details needed for SEND time-series use, including nominal timing relative to dose and information that identifies measurements within the exposure context.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
For SEND PC data, FDA’s June 2026 guide expects enough timing and grouping information to support time-series graphs and automated pharmacokinetic parameter calculations.
Key details
Core IssueFDA’s June 2026 guide describes PC-domain timing/grouping details needed for SEND time-series use, including nominal timing relative to dose and information that identifies measurements within the exposure context.
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
Provide the PC timing and grouping fields the current guide calls for so time-series measurements can be plotted and used for automated pharmacokinetic calculations.
Purpose
Preserve the timing context of pharmacokinetic concentration measurements instead of submitting values that cannot be reliably sequenced against dosing.
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 provides explicit SEND PC-domain handling for pharmacokinetic concentration results below the lower limit of quantitation (LLOQ).
FDA’s June 2026 guide says the AE domain should include all adverse events unless an indication-specific technical specification says otherwise and asks for the criterion supporting a serious-event flag.
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.
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.
FDA’s June 2026 guide describes the DD (Death Details) domain for supplemental information collected when a death occurs and expects consistency with relevant AE-domain death variables.
FDA’s June 2026 conformance guide says screen failures, when provided, should be represented as a DM record with specified planned/actual arm fields left blank.
FDA’s June 2026 guide gives DS-domain handling for multiple disposition events, including use of EPOCH or DSSCAT and a specific final-record convention for death.
