Public review comments for etmf-v1.0-csprd01: 2.1 Background

["Eldin Rammell, Rammell Consulting" <eldin.rammell@rammell.com>]

Comment type [editorial]

Impact [major]

The phrase “clinical trial content” is used incorrectly. This specification is limited to the content of the trial master file and not ALL clinical trial content. Please replace with “clinical trial master file content”.

The use of the word “automated” in paragraph 2 of 2.1 is not understood. Please explain what an “automated EDMS” is and how this differs from an “EDMS”  or remove the word “automated”.

The sentence “For those without access to EDMSs, a method to exchange, view, and navigate content offline is needed” is not understood. The use of an EDMS is unrelated to being online or offline. The issue is simply one of being able to exchange, view and navigate content on electronic repositories containing clinical trial master file content, irrespective of whether those repositories are enterprise systems, EDMSs, Microsoft Access databases or whatever.

Please change “clinical trial domain” in paragraph 3 of 2.1 to “clinical trial master file domain”; this specification is limited in scope to the trial master file only.

For many readers, including the vast majority of those outside the US, the term “archive” has a very specific meaning in a regulated environment. An archive is a repository specifically designed for the long-term retention and preservation of documents and records and NOT a pseudonym for a file system or other repository. Whilst an electronic trial master file system may additionally provide appropriate features to be an archive repository too, they are more often 2 separate entities. An electronic trial master file is more usually unlikely to be suitable for retention of trial master file content for periods in excess of 25 years, as required by EU Clinical Trial Regulation 536/2014.

The phrase “as well as preparing content for regulatory submissions” in paragraph 3 of 2.1 is not clear, is often not true and adds ambiguity to the definition of an eTMF. Regulatory submission preparation systems are more commonly completely separate from eTMF so to include this phrase is likely to result on reader confusion.

This standard for the most part does not deal with the format of documents and records, rather the metadata. Therefore inclusion of the phrase “there is no standard that defines how eTMF documents and records should be formatted for electronic export” gives the impression early on in the specification that the document addresses document format, which it does not.

The specification is concerned with the interoperability of eTMF documents and records and NOT with the export of content for regulatory submission purposes. Export formats that meet the requirements of government agencies is a requirement for regulatory submission systems and NOT electronic trial master file systems. To apply this requirement to an eTMF system that may be completely distinct and separate from an organization’s regulatory submission system adds no value. It would of course make sense to ensure an eTMF system is capable of exporting content in a format that was suitable for the organization’s regulatory submission system, but that should not be a prerequisite for an eTMF interoperability standard.

Eldin Rammell

Principal Consultant, Rammell Consulting Ltd.