Following on from an excellent discussion at our last TC meeting (March 3) I would like to make a couple of comments regarding export formats for TMF content.
1. Our prior discussion focussed on the guidance from the FDA that “export of records shall be in common formats such as PDF, XML, or SGML”, reference http://www.fda.gov/regulatoryinformation/guidances/ucm125067.htm]. It should be highlighted that this guidance from the FDA is specifically related to the provision of copies of records to the FDA. The guidance states
“You should provide an [FDA] investigator with reasonable and useful access to records during an inspection. All records held by you are subject to inspection in accordance with predicate rules (e.g., §§ 211.180(c), (d), and 108.35(c)(3)(ii)).”
However, if a sponsor chooses to provide copies of records, then the guidance applies:
“We recommend that you supply copies of electronic records by:
· Producing copies of records held in common portable formats when records are maintained in these formats
· Using established automated conversion or export methods, where available, to make copies in a more common format (examples of such formats include, but are not limited to, PDF, XML, or SGML)
In each case, we recommend that the copying process used produces copies that preserve the content and meaning of the record. If you have the ability to search, sort, or trend part 11 records, copies given to the Agency should provide the same capability if it is reasonable and technically feasible. You should allow inspection, review, and copying of records in a human readable form at your site using your hardware and following your established procedures and techniques for accessing records.”
The FDA reference should therefore NOT be taken as a general guidance on interoperability, export or exchange of documents between systems. Rather, it is the recommended approach when a sponsor chooses to provide copies of records to an FDA inspector/investigator rather than originals.
2. In relation to the general point about export formats for TMF content, I think we need to be wary about precluding specific content types unless there are strong technical reasons for doing so. The primary objective of the standard is to facilitate the exchange of TMF content between systems. If we put artificial barriers in place that only allow, for example, PDF documents to be exchanged, this will severely limit the utility of the standard. If eTMF system X provides for the storage and management of Microsoft Word documents and eTMF system Y also provides for the storage and management of Microsoft Word documents, the interoperability standard should permit the exchange of Microsoft Word documents between these two systems and should not mandate that those documents first be rendered to PDF. This is particularly important for the exchange of TMF content between CRO eTMF and sponsor eTMF, where the original native file format is often required to be transferred. In addition, whilst many eTMF systems currently in use automatically generate a PDF rendition of final documents, this is by no means applicable to all eTMFs.
Regards,
Eldin.
Eldin Rammell
Managing Director, RAMMELL Consulting Ltd
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