Latest FDA eCTD Validation Criteria Draft Guidance Adds, Removes Error Conditions

The US FDA has posted a draft version of a new “Specification for eCTD Validation Criteria” which can be found here. This document outlines many of the new error conditions that the FDA will be checking for in the next version of the validation software. I will be highlighting some of the more important changes to the criteria.

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How to Fix Common Study Tagging File XML Errors
Apr11

How to Fix Common Study Tagging File XML Errors

Study Tagging Files XML is a very common area of confusion for most people new to eCTD and XML in general. I have spent a lot of time creating the XML for sequences by hand, and have examined sponsors’ XML to determine the location of the error. Because of these experiences, I thought it would be beneficial to discuss the basic structure of the index.xml, stf.xml, and the single most common question I receive related to the STF which is, “Why am I seeing errors 1952, 1953 and are these the same error?”

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FDA eCTD Review Process Q&A

Earlier this week, GlobalSubmit and Cato Research held an educational webinar on the FDA eCTD Review Process. The purpose of the webinar was to provide an overview of the various steps and stages that a drug application goes through in order to be approved by the FDA and marketed in the United States. During the webinar, GlobalSubmit’s CTO Jason Rock discussed the FDA’s workflow, the challenges they face in the electronic...

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New FDA Study Data Specifications Differentiate Between SDTM, Legacy Formats

In January, FDA issued version 1.5.1 of Study Data Specifications. As discussed in my previous blog entry, a new specification for organizing datasets was defined.   The change has to do with how the files are organized in the file structure in which an eCTD is delivered to indicate whether they were STDM or legacy format. The new specifications for organizing study datasets and their associated files in folders are summarized in the...

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Collection of eCTD Online News, Part 1

Today’s post is a round-up of recent eSubmission-related news from the agencies, based on posts from my twitter account, www.twitter.com/kathie_clark. Next time, a roundup of articles and conferences. The regulatory authorities haven’t put out much in the way of major updates recently, but there have been some updates worth noting: ICH issued a new valid-values.xml for study tagging files see my Blog Post on The eCTD Summit for...

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