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Subject: [OASIS Issue Tracker] Created: (ETMF-7) Export formats for interoperability

Export formats for interoperability

                 Key: ETMF-7
                 URL: http://tools.oasis-open.org/issues/browse/ETMF-7
             Project: OASIS Electronic Trial Master File (eTMF) Standard TC
          Issue Type: Task
          Components: General
            Reporter: Eldin Rammell

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.

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