HL7 Stability Standard Implementation Guide Teleconference Minutes 2010-05-10
HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes
May 10, 2010
Norman Gregory (CVM), Elizabeth Cormier (CVM), Terry Hardin (Perfitech), Catherine Hosage-Norman (Sepracor), Mike Mlodzik (Fort Dodge Animal Health), Mike Yang (ScienTek Software), Jennifer Rice (Alpharma), and Diane Miller (Alpharma)
- There will be no teleconference on Monday May 17th, 2010.
- Discussed the ballot comments and what the responses will be.
- Need to find out if "Stability Study Event Report Retraction" has been removed. If so it would address some of the comments regarding missing sending a receiving roles. Section 4.6.2 would need to be deleted and the diagram under 4.1.1 would need to be changed. It would make since for "Stability Study Event Report Retraction" to be deleted and "Stability Study Event Report Revision" would be for correcting a mistake.
- It was asked is there is any reason for the structure name "Stabilitystudyrtwo 01" being used. I will check with Mead, it might stand for stability study release 2.
- Should there be receiver responsibilities? No, the message was not intended for two way communication. If it is part of an RPS submission, that will have two way communication. If you send an electronic file (e.g., SPL) to the FDA gateway you get an acknowledgement of recite and a valid message acknowledge (once there is validation package for eStability this should occur). If the message is being d=sent outside of the FDA it would be up to the receiver of the electronic message and their SOPs.
- Some items form the UML diagram are not linked to HMD correctly. I will need to check with Mead on this issue.
- Should the CPM CMETs be used by now? No, not yet. We made a commitment to align with CPM in the next release one CPM has passed ballot, that should be eStability Release 3.
- Does not apply to european law. That is correct at this time, it is for sending to FDA. But the model should work for any regulatory agency, Most of the attributes in the classes are optional or required, not mandatory and the optionality can be changed with an IG for that regulatory agency along with other code lists if needed.
- In the IG we want to have a n appendix with a simple valid XML file either bookmarked or annotations back to the specific section and each section to have xml examples especially for concepts that are not common (e.g, cycled study, freeze/thaw study, foreign address,...).
Agenda for May 24, 2010 Teleconference:
- We will continue to use Adobe connect (to join the meeting: https://collaboration.fda.gov/hl7/).
- Work on IG.