Metadata Questions

["Mr. Michael Agard" <magard@consultparagon.com>]

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