Study Start Date in FDA eCTD Study-Data Validation
FDA’s June 2026 guide explains that FDA’s automated eCTD study-data validation relies on the Study Start Date (SSD) supplied in the Trial Summary dataset and links that date to study-standardization compliance checks.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
Provide the Study Start Date in the Trial Summary data using the current FDA-required representation so eCTD validation can determine the applicable study-data standardization expectations.
Key details
Core IssueFDA’s June 2026 guide explains that FDA’s automated eCTD study-data validation relies on the Study Start Date (SSD) supplied in the Trial Summary dataset and links that date to study-standardization compliance checks.
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 focuses on the Study Start Date’s role in FDA eCTD validation rather than the broader inherited Trial Summary parameter owner.
Purpose
Provide the Study Start Date in the Trial Summary data using the current FDA-required representation so eCTD validation can determine the applicable study-data standardization expectations.
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.
In the June 2026 FDA Study Data Technical Conformance Guide, EXPSTDTC is the Trial Summary parameter code for Experimental Start Date; FDA lists it as desired (“Y”) for nonclinical Trial Summary data. This is FDA submission guidance, not a universal SEND rule detached from the current FDA-supported standards and conformance guide.
In the June 2026 FDA Study Data Technical Conformance Guide, DOSSTDTC is the Trial Summary parameter code for Start Date/Time of Dose Interval; FDA lists it as desired (“Y”) for nonclinical Trial Summary data. This is FDA submission guidance, not a universal SEND rule detached from the current FDA-supported standards and conformance guide.
In the June 2026 FDA Study Data Technical Conformance Guide, STENDTC is the Trial Summary parameter code for Study End Date; FDA lists it as conditional for nonclinical Trial Summary data (when applicable). This is FDA submission guidance, not a universal SEND rule detached from the current FDA-supported standards and conformance guide.
FDA’s June 2026 conformance guide notes that there is no single standard or best practice for all adjudication data and directs sponsors to document where adjudication data reside and how adjudicated values can be distinguished from original values.
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.
In the June 2026 FDA Study Data Technical Conformance Guide, ASOCSTDY is the Trial Summary parameter code for Associated Study; FDA lists it as conditional for nonclinical Trial Summary data. FDA notes: include it if applicable. This is FDA submission guidance, not a universal SEND rule detached from the current FDA-supported standards and conformance guide.
FDA’s June 2026 guide separates categorical noncontinuous laboratory results from numeric continuous results by using LBSTRESC, leaving LBSTRESN null, and documenting the categorical scale in the nSDRG.
FDA’s June 2026 conformance guide says a custom domain should be used only after confirming the data do not fit an existing domain, with implementation described in the clinical Study Data Reviewer’s Guide.
