Planned Dose Frequency (PDOSFRQ) in FDA SEND Trial Summary Data
In the June 2026 FDA Study Data Technical Conformance Guide, PDOSFRQ is the Trial Summary parameter code for Planned Dose Frequency; FDA lists it as Conditional for nonclinical Trial Summary data. The FDA table notes planned number of doses per interval for SENDIG Animal Rule v1.0 and recommends the parameter for FDA-supported SENDIG study types when relevant. 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, PDOSFRQ represents Planned Dose Frequency; FDA marks this parameter Conditional. The FDA table notes planned number of doses per interval for SENDIG Animal Rule v1.0 and recommends the parameter for FDA-supported SENDIG study types when relevant.
Key details
Core IssueIn the June 2026 FDA Study Data Technical Conformance Guide, PDOSFRQ is the Trial Summary parameter code for Planned Dose Frequency; FDA lists it as Conditional for nonclinical Trial Summary data. The FDA table notes planned number of doses per interval for SENDIG Animal Rule v1.0 and recommends the parameter for FDA-supported SENDIG study types when relevant.
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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, PDOSFRQ represents Planned Dose Frequency; FDA marks this parameter Conditional. The FDA table notes planned number of doses per interval for SENDIG Animal Rule v1.0 and recommends the parameter for FDA-supported SENDIG study types when relevant.
Purpose
Represent Planned Dose Frequency in the nonclinical TS dataset with parameter code PDOSFRQ, following the current FDA table, the applicable supported SEND implementation guide, and controlled terminology where relevant.
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.
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In the June 2026 FDA Study Data Technical Conformance Guide, PPTEGID is the Trial Summary parameter code for Planned Pharmacologic Target Entrez Gene 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, PPTEGSYM is the Trial Summary parameter code for Planned Pharmacologic Target Entrez Gene Symbol; 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.
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In the June 2026 FDA Study Data Technical Conformance Guide, DOSSTDTC is the Trial Summary parameter code for Start 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, 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.
