Re: [etmf] Metadata Questions

Hi Michael, Thanks for your comments.

We can address some of these issues here and at the Feb 17th meeting. In general, eTMF domain terms will be addressed in Phase 2 except where required as core metadata. Since electronic content items are 'tagged' with metadata, (sometimes manually we must assume), then the core set of required metadata for a document/content type should be compact, concise and broadly applicable.

In reply to your questions:

1. Metadata: Protocol Full Title, Protocol Brief Title, Indication(s), study phase, regulatory submission and tracking numbers: This metadata is 'non-core' and is specific to the eTMF domain. Generally, we will address eTMF domain metadata in Phase 2 of this project. There are three metadata terms for the eTMF domain that could be considered for core: Study ID, Country and Sponsor. It could be argued that these three terms should be present for every content item in the eTMF domain. Also, I believe Study ID and Country are part of every 'artifact' in the TMF RM so they are essential core terms.

2. Country codes: Country is already a defined eTMF metadata term based on NCI definition and it defines the country code format using three char codes. The proposed format is ISO 3166-1 alpha-3 country codes- Example: USA

3. Site attributes: Site ID is considered an eTMF domain metadata term. We will address eTMF domain metadata in Phase 2 of this project. Principal Investigators name (Person Name), role (Person Role) and Organization are part of the Core Metadata. We've reviewed these terms in our last meeting and we'll be revisiting the terms again at this meeting. I'll provide some more examples of how core metadata terms can be added to content types for clarification in the metadata component discussion of our presentation at the next TC meeting .

4. TMF RM Mapping: In Phase 1 we are creating a core architecture and we were not planning on doing a mapping of TMF RM terms to OASIS eTMF terms. Any development of eTMF terms, mapping of terms should be done in phase 2.

Overall the goal is to create a mapping of OASIS eTMF Domain terms to the TMF RM wherever possible. There may be some terms that the OASIS eTMF Standard TC adds that don't exist in the TMF RM. For example, I believe that some classifications such as medical device terms or medical imaging terms are likely not represented in the TMF RM model, but could be included in the OASIS eTMF model. In this case, there would be no way to map the OASIS eTMF term to the TMF RM since a corresponding TMF RM term wouldn't exist. Note that the word 'term' applies to both category, subcategory, content type and metadata.

Finally, regarding numbering - since a mapping will be developed between the OASIS eTMF Std and the TMF RM, there will be a cross-reference table that can be used by current TMF RM users or application vendors.

Thanks again Michael for your questions. Perhaps Jennifer can add your issues to the issues Jira for tracking/resolution. Also please feel free to bring any area that's unclear up at the next TC meeting during the metadata component discussion.

Best,

Zack

Zack Schmidt, President
SureClinical

Healthscience Applications
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On Mon, Feb 10, 2014 at 8:37 AM, Mr. Michael Agard <magard@consultparagon.com> wrote:

I have some questions that I hope we can discuss at a meeting, or create these items as issues for tracking purposes.

1. Will the eTMF standard manage other protocol attributes such as: Protocol Full Title, Protocol Brief Title, Indication(s), study phase, regulatory submission and tracking numbers? I assume these should be the same properties used in HL7.

2. Will the standard manage Country synonyms such ISO 2 and 3 digit codes, ISO Country Name and ISO Country Abbreviation?

3. Site attributes should include the Principal Investigator's name. How will changes in this data be managed? Sometimes site identifiers require concatenation of the country code and site number in order to form a unique combination. How will this be handled?

4. Will the Categories, Subcategories and Content Types have attributes such as the numbering scheme, or mapping details to the DIA TMF Reference Model?

Michael