Federal Information Processing Standards (FIPS) and MD5 Checksums

There is an old security requirement that the United States Federal government imposes that will affect the FDA. That security requirement, otherwise known as Federal Information Processing Standards (FIPS), does not allow any program to calculate MD5 checksums, as defined in the eCTD 3.2 specification. This is a potentially huge problem for everyone creating eCTD submissions. What is the FIPS? The Federal Information Processing...

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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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Benefits of Submitting INDs in eCTD Format

On March 10th, I attended the eCTD 2010 conference in Philadelphia. The conference attendees included a number of smart and experienced eCTD professionals. During a round-table session, I asked the group if they were submitting INDs in eCTD format, and if so, why they felt there was value in doing so. I asked this question because at this date only 12% of INDs are submitted in eCTD format, and I’m curious as to why the number isn’t...

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