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Type:
Improvement
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Resolution: Fixed
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Priority:
Minor
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None
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Affects Version/s: None
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Component/s: General
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None
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Environment:
Comment from Linked In
"Adding to what Michael says, I would encourage addressing the issues of whether exchanged messages are meant to be incremental or complete and stand-along. I would expect incremental messages such as used in the eCTD and RPS standards. That raises not only the issue of versioning, (of content and/or metadata such as Michael mentions) but other more complex issues familiar to people who have worked with eCTD/RPS. What if you need to logically delete a previously submitted document? Can you reclassify a document by assigning it to a different taxonomy element if it was incorrectly classified? Is there some idea or concept of a history of messages you would need to get a full picture of a specific TMF? Can content be shared among TMFS without duplication (again, a concept from eCTD/RPS)? There are a large number of such issues that must be addressed to produce a usable standard." - Kathie Clark, eTMF Product Manager at Wingspan Technology
found in - http://www.linkedin.com/groupItem?view=&gid=5161997&type=member&item=5793078168692731904&commentID=5793692195496157184&qid=dd39c552-88da-4680-a8e6-79ddd857f7c6&trk=groups_items_see_more-0-b-cmn#commentID_5793692195496157184