SS 04Dec2013

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Meeting Record


When: 09:00 am - 10:00 am, 04Dec2013
Place: Teleconference
Facilitator: Hanming Tu
Scribe: Hanming Tu
Attendance: Mary, Mike, Dirk, Scott, Hanming
Excused:

Agenda
  1. Review action items
  2. Outreach update
    1. DIA 50th annual conference preparation
  3. Project Update
  4. Steering Committee
    1. Action Item: Please provide a list of the projects within your working group that will need space at the March meeting and any details you can provide regarding needs.
    2. Due Date: October 11

General discussion

  • Action item updates
    • Dirk: looking into document development options:
      • Tool for review: agilewords.com; Wei and Mary had joined and will start testing.
      • Project management tool - need more thinking and testing
    • Dirk: will work on outreach tracking tool: it is done and the wiki page is created.
    • Dirk: reach out to SAS on web editor: talk to SAS about it and would get back by the end of December
    • Dirk: Wikipedia entry for PhUSE: it is almost done
    • Dirk: DIA program for publishing white paper. No whitepaper was published in DIA program. There will be fees and relatively inexpensive. Need to figure the fee structure. It is not very possible and we will not pursue on this with DIA.
  • Mike: There are 23 people sign-up for the March meeting and one of them has signed up for Script-athon.
  • Scott: has updated the TransCelerate section.
    • Mary/Steve: FDA/Statistical science workshop - September for abstract; Steve will be in the workshop.
    • Steve/Mat will check into whether it is possible to get FDA script TOC into repository
      • Armando will take over Chuck's responsibility and we will continue to pursue this.
    • White paper: Steve requires to change three items in the whitepaper; and we concurred. Mary already talked to Chris and made the changes.
  • Outreach update
    • DIA 50th annual conference preparation: we have already submitted session proposal. We should hear back by December 6.
    • PhUSE/CSS in March and PharmSA
    • Steve: TransCelerate presented in CDISC Interchange; Got message out about script-athon.
    • PhUSE meeting in Brussels is over. Here is the feedback from Lina:

Lina presented the poster and talked with 10-12 persons, but no one had hear about the collaboration between PhUSE and FDA. She noticed that there are interests in the white paper and some asked where they could find the white paper. Chris Decker was leading the session and give update about the collaboration between PhUSE and FDA. There were some good discussions. She also noticed that there was a lot of interest in the code-a-thon, it seems that no one was interested in submitting a script. So it’s still a long way to go. We may need think more ways to get source scripts in the repository.

  • Project Update
    • P03 (Mike): will send out announcement for next project meeting;
      • Script-athon is on the CSS 2014 announcement page
      • In minor hold, waiting for planned updates on:
        • getting SAS environment
        • getting output targets
        • getting CDISC ADaM pilot datasets on repository
      • Also, exchanged mails w/Steve Wilson about getting a "shoutout" about Standard Scripts at CDISC Interchange meeting next week.
      • have a proposal: http://www.phusewiki.org/wiki/index.php?title=Codeathon_2014_proposal
    • P08 (Mary): had one meeting; the first whitepaper is pretty much done. Try to get the other whitepaper ready before the FDA/PhUSE meeting in March 2014. The 1st whitepaper already finalized (10/1).
  • Scott: TransCelerate Update - gave explanation on the slides.
    • TransCelerate will present at PhUSE March 2014 meeting.
    • TransCelerate will help CDISC and CFAST develop Data Concepts, CDASH and SDTM standards for a number of Therapeutic Areas:
      • Asthma: has been published and approved as a standard.
      • Alzheimer’s Disease v2.0
      • Multiple Sclerosis
      • Diabetes in adults
      • Cardiovascular Endpoints
      • QT studies
      • Traumatic Brain Injury
      • Schizophrenia
      • Virology – Hepatitis C
      • Oncology – Breast Cancer
      • For an updated list with the current status: http://www.cdisc.org/therapeutic
    • Once the CDASH and SDTM standards are created (through CDISC):
      • PhUSE can define the TFLs (Tables, Figures, Listings) that can be used for the TA that align with the previous white papers.
      • This should lead to the definition of the ADaM structures.
      • Have enough definition for Standardized Statistical programming and the script-a-thon
  • Project groups:
    • how to energize the groups?
      • Script-athon could be a mean to get people involved and energize the groups
    • how to get regular communication to the users?
      • send out meeting updates

Follow up

Action Items
  • Dirk is going to invite more people to test the agileword tool
  • Dirk reach out to SAS on web editor
  • Mike provides slides for CSS web meeting to Hanming and Steve before December 18.
  • Steve/Mat will check into whether it is possible to get FDA script TOC into repository
    • Script list: Review the list from Steve and discuss whether we can post it
    • Usage stat of the FDA scripts
    • Actual scripts
Next Meeting

Time: 9:00 am - 10:00 am (Wednesday)
We will conduct this meeting once every other week (twice a month).

Agenda for next meeting: Next meeting: TBD



Last revision by Jmbodart,10/13/2015