|
The Telematic Implementation Group for electronic submission and ICH Implementation(TIGes) has published additional clarification on the draft eCTD validation criteria 3.1 as published earlier this year (see our related News article).The additional clarification concerns the validation checks that require the presence of the previous eCTD lifecycle sequences to be performed correctly.
The first key message included in the clarification document is that "the revised criteria for technical validation of eCTD sequences (v3.1) should be treated as a single complete set of tests and not be divided in any way."
Corresponding criteria are marked with an 'Y' (for "Yes") in the column "Check can only be performed in context of other eCTDs in the lifecycle?" of the official eCTD validation critieria 3.1. The TIGes now confirms that all validation checks are expected to be done in its entirety, including those criteria for which preceding sequences need to be present when testing. According to the TIGes "The classification of criteria with a “Y” was intended to indicate that the result will be unreliable if the sequence is tested in isolation. When testing individual sequences without the rest of the eCTD life cycle present, the results of tests on these criteria should be interpreted carefully and the tools should preferably indicate this in the test report. The classification “Y” should not be interpreted as defining a second set of criteria to be used in certain cases only."
The other key message from TIGes is that a submission is technically valid "only if all Pass/Fail criteria are passed, whether the criterion is marked with a “Y” or not." The TIGes would furthmore prefer that corresponding validation reports from software tools would state specifically "which sequences were present when the test was carried out, such that errors relating to missing sequences can be
interpreted correctly."
Detailed information can be obtained from the original clarification document that is available for download in MS Word format from the TIGes website (see link at the bottom of this article)
[Source: TIGes eSubmission website]
- Related News:
 TIGes updates clarification on the new EU eCTD validation criteria - 14.07.2011 09:57- EU eCTD and NeeS validation criteria updated by TIGes - 18.03.2011 16:18
<- Back to: News Archiv
|
