Feedback from QUMAS on OASIS eTMF interoperability draft spec
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Section 4 – Core Technology - Page 10 - A sponsor and a CRO may use a different term to represent the same content in an eTMF.
- This is usually driven by the sponsor so that the same term is being used consistently and so there isn’t any confusion when it is time to submit the
document as part of an application. Does the term appear as a title or document name when the document is used in a submission, given that naming convention standards have to be adhered to? Are we saying at the end of the day the Standard Metadata Vocabulary
is what is ultimately submitted to an agency and if so why not use that vocabulary from cradle to grave? Does this approach streamline and eliminate the need to cross-reference terms from various entities.
- This is usually driven by the sponsor so that the same term is being used consistently and so there isn’t any confusion when it is time to submit the
document as part of an application. Does the term appear as a title or document name when the document is used in a submission, given that naming convention standards have to be adhered to? Are we saying at the end of the day the Standard Metadata Vocabulary
is what is ultimately submitted to an agency and if so why not use that vocabulary from cradle to grave? Does this approach streamline and eliminate the need to cross-reference terms from various entities.
- Section 5
- Does the Primary Category, Sub-Category and Content type level map to the Zone, Section and Artifact level of the DIA Reference Model?
- Would it be helpful to create a standard of minimum metadata that has to be added for each content type an piece of content based on published guidance
to ensure interoperability, but then allow organizations to add any additional metadata they want as long as they meet the minimum standards for interoperability?
- The three digit numbers used by the DIA Reference model are unique identifiers for individual artifacts. This is in addition to having a 2 digit id
for each artifact within a section. Is the content type in OASIS equivalent to an artifact vs. a type of document eg, TMF Trial level document, TMF Country level document or TMF Site level document? Section 5.2 would suggest not, but 5.3 suggests this is
the case.
- Does the Primary Category, Sub-Category and Content type level map to the Zone, Section and Artifact level of the DIA Reference Model?
Robin O’Sullivan
Biovia Product Manager
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Dassault Systèmes
| QUMAS, Cleve Business Park. | Monahan Road, Cork | Ireland
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