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.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
Submit scheduled visits, whether or not they occurred, and unscheduled visits together in one structured SV-domain dataset as described by the current FDA guide.
Key details
Core IssueFDA’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.
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
The guide also identifies specific non-standard visit variables for the SV dataset; those details stay within this canonical rather than being split into separate thin pages.
Purpose
Submit scheduled visits, whether or not they occurred, and unscheduled visits together in one structured SV-domain dataset as described by the current FDA guide.
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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