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Meeting Minutes 10 May 2011

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Notes from Teleconference 10 May 2011


Marc’s comments and questions on the latest draft of the model walk-through were discussed.

A major point concerned the lack of a place for a regulatory status code (drawn from a regulator-defined controlled vocabulary), as opposed to the status code (drawn from a standard HL7 code set) in Submission and Application.

Keith suggested that the classes for Submission and Application be made clones of the RIM Document class so that there would be a completion code attribute to carry this information. It was decided to recommend this change to the model and to change the section entitled Statuses And Transitions accordingly.

Marc wondered how the documents shown in Figures 3 and 4 were held together. Keith said that they were drawn as if they were actually nested but this was not the case because a note on the model says that the component relationship can only reference a document by id. Documents are not actually nested but are separate objects where simple documents which reference files, become part of compound documents that reference other documents – simple or compound – by their id. It was agreed that drawing them this way was confusing; Keith offered to draft a new version of the documents section for Joe & Joel with a more representative way of drawing documents.

This same consideration applies also to Figures 5 and 6.

Marc also asked if an amendment submitted as a separate (simple) document was referenced by the same CoU. The answer is that a second CoU is required in this case to get the amendment to file following the prior document.

Figure 6 represents the alternative method where an amendment is submitted as a simple document (referencing the file carrying the amendment content) accompanied by a compound document in which both the prior document and the amendment are component. In this case a CoU referencing the compound document is also submitted as an updated version of the CoU(s) referencing the prior document, rendering the prior CoU obsolete.

There was additional discussion of the function of some of those classes associated with submission, Mode, Review and Product Category. It was agreed that better definitions of the uses of these classes are needed.


There was insufficient time left in the call to make a reasonable start on the comments and questions on the Glossary that Klaus had circulated. Keith said that he would try to post them to the wiki, but might not be able to do so before the next call; he also noted that he would be traveling on May 17 and would not be able to join that call.