Study Identifier Reconciliation with SPREFID in FDA Study Data
FDA’s June 2026 guide uses the SPREFID Trial Summary parameter to reconcile study identifiers when the identifier used in TS cannot match the STF or eCTD v4 Study Id Study Title keyword.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
When identical study identifiers across TS and the relevant eCTD study identifier are not feasible, include the referenced study identifier in TS using SPREFID as described by current FDA guidance.
Key details
Core IssueFDA’s June 2026 guide uses the SPREFID Trial Summary parameter to reconcile study identifiers when the identifier used in TS cannot match the STF or eCTD v4 Study Id Study Title keyword.
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 page is limited to the FDA study-identifier reconciliation use of SPREFID and does not replace the broader inherited Trial Summary parameter guide.
Purpose
When identical study identifiers across TS and the relevant eCTD study identifier are not feasible, include the referenced study identifier in TS using SPREFID as described by current FDA guidance.
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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