Public review comments for etmf-v1.0-csprd0

Thank you for the opportunity to comment.

Please find attached a summary of my review comments.

The technical specification is going in a beneficial long-term direction! The content model however, raises severe concerns.

General observations

The TMF Reference Model has been developed by over 350 industry experts and has been implemented in numerous systems; There is no clear justification provided, why we should switch to another content model.

My company’s application which is based on the TMF reference model does not provide the flexibility to easily switch between models – like probably most applications in use in the industry. We also have integrations with the submission platform which makes the costs to change unjustifiable and will lead to our inability to conform with an industry TMF standard.

Furthermore, considerations are being made to cross-reference the TMF and EDM model. We need stability in the standards and well managed change, not random replacements

The OASIS standard was expected to set the technical standard to exchange document information, whereas the widely accepted TMF Reference Model is setting the content standard, (e.g. attributes, vocabularies and artifacts etc.). Within the context of the proposed OASIS Classification scheme this means that the OASIS proposed CareLex model is an example of an ”organization specific content type or category” whereas the TMF Reference Model must be the domain specific base model.

Comments specific to the content model http://docs.oasis-open.org/etmf/etmf/v1.0/csprd01/vocabulary/Oasis-eTMF-Metadata-Vocabulary-Spreadsheet-201406-R01.xls:

Any change (deletion, change, addition) must have good business rational. Please provide the rational as expected in a managed standard change management process
Artefacts you deleted are in use at my company; please keep them
Apply consistency in the level of granularity provided. Some taxonomy has a deeper content classification whereas other areas have broader content types and attributes to distinguish further; The different image types for example should not be separate artefacts
Detailed comments in the attached “Oasis-eTMF-Metadata-Vocabulary-Spreadsheet-201406-R01 (1)”, column: K

Comments specific to the technical specification (http://docs.oasis-open.org/etmf/etmf/v1.0/csprd01/etmf-v1.0-csprd01-COMMENT-TAGS.html):

· All comments in the attached “Comments regarding the tech specification.docx”

Regards,

Karin Schneider

-----------------------------------------------------------------------------------------------------------------------------------------------------

Karin Schneider

Global Regulatory Affairs, Document Management Enablement Head

Janssen Research & Development

920 Route 202, Raritan, NJ, 08869

( (+1) 908 704 4766 : È (+1) 908 507 8905 Conference Code: 30139671 *: : kschnei1@its.jnj.com

CONFIDENTIALITY NOTICE: This message is intended only for the individual(s) or entity to which it is addressed and may contain information that is privileged, confidential and exempt from disclosure under applicable law. If the reader of this message is not the intended recipient, he/she is hereby notified that any dissemination, distribution or copying of this communication is strictly prohibited. If you have received this communication in error, please notify the sender by telephone and delete the e-mail from your system immediately. Thank you.

etmf-comment message