FDA’s June 2026 guide specifies how conditionally branched questionnaire items should be represented in QS submission data.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
FDA’s June 2026 guide gives QS-domain handling for conditionally branched questionnaire items, including QSCBRFL and different result/status treatment depending on whether instrument instructions specify how skipped branched items are recorded or scored.
Key details
Core IssueFDA’s June 2026 guide specifies how conditionally branched questionnaire items should be represented in QS submission data.
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
Include conditionally branched items in the QS dataset and follow the instrument’s instructions for scoring/recording them; use the guide’s QSCBRFL and status/result conventions when the item was not done because of branching.
Purpose
Preserve the instrument’s intended branching semantics while making skipped or conditionally answered questionnaire items explicit to reviewers.
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 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.
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.
