CSR eCTD Publishing
Assemble a clinical study report's documents into a validated, submission-ready eCTD package. This is the CSR Publishing tool, recreated here as a standalone, in-browser demo.
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What it does
Organizes a clinical study report's documents into the ICH E3 / eCTD Module 5 structure, validates them against PDF and eCTD rules, computes a checksum per document, and generates the eCTD backbone (index.xml) for a regulatory submission.
How it works
- Places each document into the eCTD tree (Module 5.3.5.1) by its ICH E3 Section 16 code.
- Validates against PDF-compliance and eCTD-specific rules (file naming, bookmark depth, PDF/A, page size), flagged by severity (error or warning).
- Computes an MD5 checksum per leaf and writes the eCTD backbone XML, yielding a submission-ready package.
eCTDICH E3
ValidationMD5
The demo uses a sample CSR (Study XYZ-301). The full CSR Publishing app handles real document uploads, annotations, and a packaged .zip eCTD export.
Static preview - click to open the live, interactive demo