FDA’s June 2026 conformance guide describes technical rejection criteria as automated inbound validations used by CDER and CBER to assess specified standardized study-data submission requirements. These requirements are current FDA technical-conformance guidance for electronic study-data submissions and should be rechecked when FDA guidance, supported standards, or eCTD specifications change.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
Check the current technical rejection criteria that apply to the submission and correct conditions that would cause automated inbound rejection.
Key details
Core IssueFDA’s June 2026 conformance guide describes technical rejection criteria as automated inbound validations used by CDER and CBER to assess specified standardized study-data submission requirements.
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
These requirements are current FDA technical-conformance guidance for electronic study-data submissions and should be rechecked when FDA guidance, supported standards, or eCTD specifications change.
Further guidance
Content
Technical rejection criteria are a defined inbound-validation layer and should not be conflated with every conformance warning or reviewer-facing data-quality issue.
Purpose
Check the current technical rejection criteria that apply to the submission and correct conditions that would cause automated inbound rejection.
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.
