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.