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The US Food and Drug Administration has released a Draft version 2.0 of the "Specifications for eCTD Validation Criteria". The specifications are detailing the validation criteria applied including an error description/explanation, necessary corrective measures to correct the error, and the severity level of the error.
In the corresponding release note the FDA explains that:
"..the newly released DRAFT Validation Codes document contains error conditions that have been incorporated into FDA's next version of validation software. The new validation error conditions contained in this document are NOT currently in use. Furthermore, these error conditions are subject to change in severity level, description and corrective action. Extensive changes are not anticipated. When FDA deploys the new eCTD valdiation software, currently scheduled for June, 2011, a final version of this document will be published".
The new Draft eCTD validation criteria includes many new error codes (58 new codes) compared to version 1.0, whereas 14 error codes have been removed due to redundancy, non-occurrence or other reasons.
For 2 existing error codes, codes #1085 (Leaf element path length exceeds maximum (230 characters)) and #1561 ( Circular relationship found in related sequences) the severity level was raised from "low" to "medium" (#1085) and from "medium" to "high" (#1561), respectively.
The new Draft specifications for eCTD validation criteria, v. 2.0 are available for download from the FDA website as PDF file or MS Excel spreadsheet (see link at the bottom of this article).
[Source: FDA website]
- Related News:
 FDA releases new version of their eCTD validation criteria and updates transmission specification - 06.01.2012 18:02
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