MDM Definition project
November 20, 2013, 11:00-12:00 EST
FDA/PhUSE Metadata Management: Metadata Definition Work Group
Minutes – Weekly Conference Call: 2013-11-13
Presiding Co-facilitator: Mitra Rocca
Duration: 60 minutes
Time:11:00 AM Eastern U.S. – 12:00 PM EST
Webex:
Attending / PhUSE/FDA WGMembers / emailX / Isabelle de Zegher / / Facilitator
X / Mitra Rocca / / Co-facilitator
X / Marcelina Hungria /
Tim Church /
Julie James /
Susan Zhao /
X / Yun Oldshue /
Sam Hume /
Kenneth Stoltzfus /
Gregory Steffens /
John Leveille /
Praveen Garg /
Greg Fuller /
Terek Peterson / PetersonTerek@PRAIntl.com
Steve Ward /
Aimee Basile /
John Hunter /
Agenda:
- Update from the Emerging Technologies steering committee meeting
- Value Level Metadata (VLM)
- Finalize the section on the Controlled Terminology (CT)
- Start on Master Data Management Section
Isabelle provided an update on the FDA/PhUSE steering committee, held on Nov. 19, 2013.
We will aim to release the meta data definition document in January 2014, as soon as we have a good draft. We will place it on the PhUSE wiki and welcome comments.
Additionally we will work with SDOs (CDISC, HL7) to present to them via a Webinar and look forward to receiving comments.
Value Level Metadata (VLM)
Marcelina will go back to define.xml team and have recommended definition by the second week of December. (December 11, 2013)
Q: What is the actual VLM in the example below (highlighted in blue)?
A: VLM is a set of information. Set of attributes for a variable under a set of condition. This was a difficult section for the define.xml team. We had a lot of discussions on this, before changing the definition.
Q: Is there any chance that they would drop that term (VLM)?
A: Even the displays of the meta data that FDA receives refers to VLM. People might get confused, If there is a need for a new term.
VLM Governance Process
In the current submissions to FDA and working on validating define.xml sponsors refer to controlled terminologies and extensions, however the governance process is not clear or sometimes does not exist.
Ex: lab test units, many units to select from.
Added examples to the VLM section as well as the recommended definition.
Master data management
We had preliminary discussions on the Master data management section.
Master data is dynamic pick list shared across different Systems. Reference data is a fixed system.
Master reference data = master data + reference data consumed in the same way but there are produced in a different Way.
Next week’s meeting will be cancelled due to the Thanksgiving holiday in the US.
The next MDM meeting will occur on Dec. 04, 2013.