SS 02Mar2016

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Meeting Record

When: 10:00 am - 11:00 am, 02Mar2016
Place: Teleconference
Facilitator: Hanming Tu
Scribe: Hanming Tu
Attendance: Hanming, Dante, Mary, Dirk
Excused: Steve, Mike, Peter

  1. Steering committee - Mary
  2. Review action items
  3. Plan for PhUSE/CSS
    1. Prepare for posters
    2. Prepare for the workshop session
    3. Scriptathon or something - October PhUSE Annual conference
  4. Project Update
  5. Special events

General discussion

Steering Committee Update - Mary
  • New projects are proposed and to be processed in the committee
  • New process such as in Standard script WG to be tried in other groups
  • Collaborate with CDISC
  • PhUSE contribution in different areas such as visualization, implementation, tech stack, repository, etc.
  • Start Webinars Wednesday in 2016
  • Motivation for project progress: Selected Steering members will work with Standard Script WG.
  • Possible project from best practices for data collection instruction in Optimizing Data Standard WG.
Review action item
  • Get the rest of scripts from FDA - action for Steve/Mat; Mat will send an email to Crystal A.
  • Steve: Review CTSpedia codes - it has done before and need to review it again. It may be down the road and it is a low priority.
  • Mary: We should make the JumpStart scripts enhanced so that FDA and others all use the scripts from the repository; not the other way around.
  • We have got 7 sets of scripts from FDA.
Planning for PhUSE and CSS
  • Prepare Posters: revive the version and show concrete steps towards the version.
    • how many? two (whitepaper and repository)
    • assignment: Mary - whitepaper; Dirk - repository; draft done by 1/8/2016
  • Prepare workshop session:
    • Index page creation
    • Dante: whether is it possible to propose a project related to generate test data
    • Dirk: focus on Github environment
    • We need to pre-create Github accounts for participants who will do the demo.

Here is the updated version of agenda for the sessions during March meeting. Please let me know if you have any question.

Highlights and action items:

  1. FDA will give us the rest of the scripts soon and we need to review the scripts - Adie
  2. Email Chris Decker to find out the details of Sunday evening plan for 5 ~ 7 pm – Mary
  3. Talk to “Modeling Analysis Results & Metadata to Support Clinical and Non-Clinical Applications” – Dirk
  4. We will need a feedback on the proposed contexts for each session, especially the topics for the Tuesday’s sessions – All
Project Updates
  • No time to get project update

Thanks to everyone who participated in the first and the 2nd meetings. Please see the below for the script assignment. The deadline for getting them reviewed and posted to the repository is 3/12/2016.

Here is the link to the suggested folder structure:

Here are a few points to be considered: 1. Make necessary changes if they are needed to make the script to work 2. Hardcoding should be voided when it is possible. 3. Make it into a new version if there is any change in the code. 4. Document the steps to make script to work and any change/feedback/recommendation in the script and macros. 5. Raise any question such as subgroup analyses in the document.

The FDA script set (SAS Analysis is uploaded to the repository under The test data sets are in this folder: You are also encouraged to use your test data to test the scripts.

Some background information: 1. PhUSE Standard Script working group: 2. PhUSE Standard Script Repository: 3. FDA already released three packages (DM, AE and MedDRA) last year: 4. FDA will release 7 packages this year: 1) Adverse Event Severity (AE_Severity – – Rebeka (Lilly) 2) Adverse Event Toxicity (AE_Toxicity – - Rebeka (Lilly) 3) Demographics (DemographicsGeneral – – Stephanie (Accenture) 4) Disposition (DispositionGeneral – – Stephanie (Accenture) 5) Exposure (ExposureGeneral – – Stephanie 6) Liver Labs (LiverLabsGeneral – – Eric Qi (Merk) 7) MedDRA at a Glance (MedDRA_at_a_Glance – – Rebeka (Accenture)

  • New Business (Steve)
    • Japanese PhUSE activities
    • Translate whitepapers into Japanese
    • Scriptathon in Japan?

Follow up

Action Items
  • FDA plan for releasing the rest of scripts - Steve/Mat
    • Meeting every month and will bring it up again
    • Mat to send an email to Crystal
  • Poster preparation: draft by 1/8/2016
    • Draft for repository - Dirk
    • Draft for whitepaper - Mary
  • March session preparation
    • Send out preparation slide template to all the project leads - Hanming
    • Set up bi-weekly meeting before the March meeting - Hanming
    • Prepare Central Tendency Package and process - Dante/Peter
    • Plan for the Monday evening session - Mike/Dante
Next Meeting

Time: 10:00 am - 11:00 am (Wednesday)
We will conduct this meeting once per month.

Agenda for next meeting: Next meeting: TBD

Last revision by Htu,03/2/2016