PP Domain for Pharmacokinetic Parameters in FDA Study Data
FDA’s June 2026 guide gives explicit naming-consistency expectations for the PP pharmacokinetic-parameters domain relative to the CSR and PC domain.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
FDA’s June 2026 guide says PP-domain visit naming should be consistent with the clinical study report and analyte naming should be consistent with the pharmacokinetic concentrations (PC) domain.
Key details
Core IssueFDA’s June 2026 guide gives explicit naming-consistency expectations for the PP pharmacokinetic-parameters domain relative to the CSR and PC domain.
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
Keep PP visit names consistent with the clinical study report and PP analyte names consistent with the corresponding PC-domain data.
Purpose
Make pharmacokinetic parameter records easier to reconcile with both the CSR presentation and the underlying concentration data.
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 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.
FDA’s June 2026 guide explicitly calls for the DV domain in submissions containing protocol-deviation data and identifies review-oriented variables beyond CDISC-required fields.
FDA’s June 2026 guide gives a direct placement rule for viral-load results in standardized clinical study data: place them in the MB (Microbiology) domain.
FDA’s June 2026 guide states an Agency preference for submitting scheduled and unscheduled clinical subject visits together in one dataset structured as the current SDTM SV domain.
