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.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
Represent a provided screen failure in DM as current FDA guidance describes, keeping ARM, ARMCD, ACTARM, and ACTARMCD blank for that screen-failure record.
Key details
Core IssueFDA’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.
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 distinguishes multiple screenings and enrollment scenarios; implementation should follow the applicable SDTM model and current FDA technical guidance.
Purpose
Represent a provided screen failure in DM as current FDA guidance describes, keeping ARM, ARMCD, ACTARM, and ACTARMCD blank for that screen-failure record.
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 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.
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.
