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:
1. Subscribe to the comment list by sending a blank email message to: firstname.lastname@example.org
2. Confirm your subscription request by replying to the confirmation email message you will receive from OASIS. Your subscription will not be complete until you respond to this message.
3. Watch your inbox for a Welcome message indicating that your subscription is now active.
4. Send your comment to: email@example.com
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.