Move Production of eCTD Submission-Ready Documents Upstream
May18

Move Production of eCTD Submission-Ready Documents Upstream

The role of eCTD-ready source documents and their impact on submission timelines and publishing efficiency is a topic that has been debated for many years. There a lot of naysayers claiming that it’s not possible to compel scientists to produce submission-ready documents, CROs cannot be made to comply with requirements, etc.

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Hyperlinking in eCTD Submissions FAQs
Dec07

Hyperlinking in eCTD Submissions FAQs

During several presentations, representatives from the FDA have conveyed some clear messages concerning hyperlinks. The general takeaway is that hyperlinks are very important to the review process as they maximize the usefulness of receiving an eCTD submission.

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Advice for Sponsors New to eCTD

I often work with the Regulatory Operations department at Cato Research and I’m always impressed by the depth and breadth of their knowledge. Cato creates submissions for such a wide cross-section of the sponsor community that their associates have truly “seen it all”, and they can cite a precedent and define a best practice in response to almost any question they are asked. Recently, I took advantage of an opportunity to interview...

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Comparing Legacy, Granular Structures for Clinical Study Reports

As most people who work with eCTD are aware, agencies will accept clinical study reports structured in one of two ways: The “Legacy” format where the study report body and appendices, exclusive of datasets and CRFs, are combined into a single PDF. In some cases, the PDF has to be subdivided in order to remain within the ICH file size limit of 100 MB. The “Granular” or “E3” format, where the study report, especially the appendices, are...

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Swissmedic Publishes M1 eCTD Specification, Validation Criteria

SwissMedic has issued a package of eCTD related specifications Swiss M1 Specification for eCTD Other Documents (DTD/MOD) Swiss eCTD Validation Criteria I have only done a cursory analysis as my day job is a bit overwhelming at the moment. The specification differs notably from the EMEA spec in several areas: SwissMedic has issued their own file and folder naming conventions for M1 as of course their M1 contents differ from EMEA Module...

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