As you probably know, the draft eTMF Standard Specification is currently on a 45-day public review cycle. This review window closes on Friday 8th August.
We have been asked by a few people to provide concrete examples of feedback that can be provided. As an example, the vocabulary taxonomy being proposed by the OASIS eTMF Technical Committee includes the following:
- All trial-level IRB/IEC documents (other than meeting materials, file notes and tracking documents) are being considered a single artifact/content type.
- All site-level IRB/IEC documents will be considered different content types to the equivalent trial-level IRB/IEC documents and classified within the Site Management zone rather than the IRB/IEC zone.
- There is no provision for country-level IRB/IEC documents.
- An “IRB/IEC-approved” ICF is considered a different artifact to the master ICF submitted to the IRB/IEC. The same applies to subject diaries, questionnaires, information sheets, subject participation cards etc. Approval of a document is more usually considered a property of the document (metadata) rather than changing the content or artifact type.
- The Site Management zone includes a section specifically for documents that relate to a specified site (“Investigator Documents”). This section contains 39 separate artifacts or content types. Outside of this section are listed other artifacts which are also site-specific i.e. inconsistent classification.
If you have concerns about any of these specific points, please review rows 82 to 152 of the OASIS vocabulary [http://docs.oasis-open.org/etmf/etmf/v1.0/csprd01/vocabulary/Oasis-eTMF-Metadata-Vocabulary-Spreadsheet-201406-R01.xls] and send your comments back to the Technical Committee before the deadline expires on FRIDAY 8TH AUGUST. As a reminder, to send comments to OASIS, please follow the instructions below:
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Once this review window closes, there will be no further opportunity to provide comment on this content. Future review cycles will only permit comment on changes since this initial draft.