CDISC Data Standards: Understanding the Guidance for Standardized Study Data
Oct31

CDISC Data Standards: Understanding the Guidance for Standardized Study Data

In December 2014, the US FDA published a binding guidance document, Guidance for Industry – Providing Regulatory Submissions in Electronic Format – Standardized Study Data, that establishes a requirement for submitting study data (clinical and non-clinical) in electronic format conforming to CDISC standards. After the publication of this guidance, all studies with a start date 24 months after the publication date (December 2014) must use the appropriate FDA-supported standards, formats, and terminologies specified in the Catalog for NDA, ANDA, and certain BLA submissions. Study data contained in certain IND submissions must use the specified formats for electronic submission in studies with a start date 36 months after the publication of this guidance.

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Updated ICH eCTD Specification Sets Requirements for Collapsed Bookmarks, Unique Headers or Footers
Apr08

Updated ICH eCTD Specification Sets Requirements for Collapsed Bookmarks, Unique Headers or Footers

The International Conference on Harmonization recently published a new Specification for Submission Formats for eCTD document. The document achieved ICH step 4 classification, meaning it’s approved for use by all regions. Collapsing bookmarks when documents are opened, a requirement for unique headers or footers on all pages and a limited set of fonts that are recommended for embedding are among the most notable new rules.

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How Unwritten Agency Rules Affect eCTD System Migration
Feb25

How Unwritten Agency Rules Affect eCTD System Migration

The true challenge of eCTD migration is your impact analysis (i.e. downtime, architectural changes and environmental changes) and determining whether or not your selected vendor supports unwritten Agency rules. Bear in mind that subtle differences exist among vendors who have implemented eCTD systems. You need to ensure that your chosen vendor has experience migrating submissions, not only from your existing system, but from all systems that generated eCTD that you now have to manage.

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Hyperlinking: Making the Most of Navigation in eCTD Submissions
Feb05

Hyperlinking: Making the Most of Navigation in eCTD Submissions

When authors generate documents intended for electronic submission they use blue-colored font to indicate where a hyperlink should be added to allow the reviewer to easily access the cross-referenced information. Hyperlinks guide the reviewer closer to the source data or supportive information cited in the body of a document. There are a few industry standards with regards to hyperlinking in submissions.

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Integrating Document Management and eCTD Publishing Systems
Apr26

Integrating Document Management and eCTD Publishing Systems

Most Tier I and Tier II sponsors maintain their submission documents in an electronic document management system (EDMS). It’s obvious that software that creates electronic (or paper) submissions must work with the documents managed in the EDMS. But what is not so obvious is the optimal integration between an EDMS and a publishing tool.

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