Emerging Technologies Working Group Meetings

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Meeting Agendas

May 7, 2014

1. Project Updates

2. Steering Committee Items

April 2, 2014

1. Project Updates and CSS Meeting

2. Steering Committee Items

March 5, 2014

1. Plan for the March 2014 CSS Meeting:
Tuesday, 3/20, 1-2:30: Working Group Updates: Frederik/Scott, Isabelle, Tony -send slides to Crystal for compiling? presenter(s)?
Would we like an introduction? Steve, Matteo, Lilliam?
Phones and dial-in numbers will not be available - but folks are welcome to try using their own
We're in one of the great rooms - 2 projectors total for all project teams
Agenda: File:20130318-20130319-agenda.doc

Logistics for breakout sessions:
Slides for each session? Bring your own slides and computer for sharing....
Isabelle: propose to have “ambassador” from our working group to tour around each different working group to explain and discuss this in (based on the need we can split ourselves).

Monday 3/18, 1-2:30 PM – Working Group Breakout Session - Welcome, Introductions, and Sharing

  • Intro to briefly describe ET working group to new folks- Steve
  • Project Agendas and Sharing – each group to talk about their projects and share their agendas for the two days
  • Semantic Tech – Frederik/Scott
  • Metadata – Isabelle
  • The Cloud - Tony

Monday 3/18, 3:00 – 4:30 PM - Project Team Breakout Sessions

Tuesday 3/19, 8:30 AM – 10 AM:

  • Prioritization of 2014 projects - Lilliam to Moderate

Logisitics? Each group presents their own priorities? Asks for Participation from other members of the working group?

Tuesday 3/19, 10:30 AM - 12 PM - Project Team breakout meetings


2. Project Updates

February 5, 2014

1. Plan for the March 2014 CSS Meeting:
Tuesday, 3/20, 1-2:30: Working Group Updates: Frederik, Isabelle, Tony
Would we like an introduction? Steve, Matteo, Lilliam? (Crystal may not be available)
Agenda: File:20140319-20140320-agenda.doc

2. Project Updates

January 9, 2013

1. Project Updates

2. Plan for the March 2014 CSS Meeting:
Open session for everybody – as last year – to re-discuss the need/scope of the 3 additional projects that were identified last year and not started (see enclosed document slides 10 – 11 - 12) EmergingTechnologies-March 2014 CSS Project Prioritization


December 4, 2013

1. Project Updates

2. Steering Committee Items

3. Quarterly Updates


September 11, 2013

1. Project Updates

2. Steering Committee Items

3. Quarterly Updates


June 5, 2013

1. Project Updates

2. Steering Committee Items:

3. Quarterly Status Update Due by June 13, 2013


April 26, 2013

1. Project Updates

2. PhUSE Steering Committee Items

a. PharmaSug Presentation(s)?

Meeting Minutes

April 2, 2014

====Attendees: Isabel de Zegher, Frederik Malfait, Anthony Hewer, Steve Wilson====

Project Updates:

Tony --

Fantastic CSS meeting
- his project's engagement greatly exceeded his expectations
- level of contribution, members present had renewed enthusiasm
- came out with lots of project actions

Cloud project
- continuing to iterate on materials
- Socializing this material -- spin out discussion during CSS. No conclusion but good discourse on the matter. Whole matter tabled for Phuse board meeting.
- Tony is meeting with Steven Banford of PHUSE on this in preparation for the annual PHUSE conference in October. Tony will ask him if topic of socialization was discussed at phuse board meeting and ask if he has thoughts from phuse perspective
- Cloud project investigating other means and solutions to help us in short and medium term, and wider audience by virtue of the CSS meeting two weeks ago.
- Presented at Innovation Forum at FDA


Isabelle --

Update: moving forward, will put info on PHUSE wiki

CSS meeting - Great forum and great atmosphere

Discussed using docket process to provide input on guidances from FDA.
- e.g., 2014 technology guidance for cloud; may not be possible to use official docket to suggest wording to go into guidances that are not put out yet.


Frederik:

CDASH, SDTM, SEND and ADaM User guide
- end of April will have user guide done
- then start CDISC public comment
- artist representation, formal model

Study design team
- meet with Jeff next tuesday at cdisc interchange
- call with cdisc to align different initiatives on the protocol

draft rdf model and tools
- need export facility in rdf format
- representing rdf data analysis results: two big tables with 15-20 people.
- rdf rep of cdash -- another team breakout as css. broke out second day with a few people


Steve Wilson --

Cloud and socialization
- There was another meeting at FDA post CSS.
- Internal group with 4 coleads


Hospital informatics systems
- breakout session on second day with Isabelle attending
- 5-6 people, starting up a new group.
- From HHS getting push to have coordinated effort given efforts to make hospital records electronic; this is getting more attention at FDA


Steering Committee Items:

Frederik --
- Nothing to report, last meeting cancelled
- Any issues for him to take to them?

Steve --
- Main PHUSE meeting in October.
- Is there any coordination with emerging tech group and annual mtg?

Frederik --
- Last year one hour CSS could present on some of the working groups.
- Went well last year and could ask again this year.

Tony --
- chatting with Steven Banford later.
- Special 2hour slot Steven is coordinating. Topic is related to cloud adoption across industry.
- Steven has in mind to invite Tony and Chris Wallie (web services) as well as players around and outside industry to give introduction to cloud technology in other sectors.
- separately Tony submitted abstract to that conference about cloud in effort to socialize to a wider audience. New air time and wider audience, and will have more to tell by then.


Steve -- Pharmasug (sas users group) re: script writing, how to reach out to them or is it appropriate given vendor supported group -- steering committee questions.

March 5, 2014

1. Plan for the March 2014 CSS Meeting:
Tuesday, 3/20, 1-2:30: Working Group Updates: Frederik/Scott, Isabelle, Tony -send slides to Crystal for compiling? presenter(s)?
Crystal to follow up with Scott and Frederik about slide collection
Would we like an introduction? Isabelle will give intro, each project will give their own update
Phones and dial-in numbers will not be available - but folks are welcome to try using their own
We're in one of the great rooms - 2 projectors total for all project teams within working group

Logistics for breakout sessions:
Slides for each session? Bring your own slides and computer for sharing....
Isabelle: propose to have “ambassador” from our working group to tour around each different working group to explain and discuss this in (based on the need we can split ourselves).
Metadata woudl like to communicate their work to the ET team, but also to the other working groups - how? Steve and Isabelle will follow up on waht working groups to pursue and


Monday 3/18, 1-2:30 PM – Working Group Breakout Session - Welcome, Introductions, and Sharing

  • Intro to briefly describe ET working group to new folks- Steve
  • Project Agendas and Sharing – each group to talk about their projects and share their agendas for the two days
  • Semantic Tech – Frederik/Scott
  • Metadata – Isabelle
  • The Cloud - Tony

Monday 3/18, 3:00 – 4:30 PM - Project Team Breakout Sessions

Tuesday 3/19, 8:30 AM – 10 AM:
Socialization of Deliverables: Publication of work that's been done. How do we include PhUSE and other working groups in this conversation? Steve will advertise this working session in his collaboration session (Monday morning) Tony will moderate this session, with input from Isabelle, Frederik, and Steve

Tuesday 3/19, 10:30 AM - 12 PM - Project Team breakout meetings

January 9, 2014

====Attendees: Crystal Allard, Isabel de Zegher, Frederik Malfait, Anthony Hewer, Matteo DiTommaso, Steve Wilson, Luke Dunlap, Lilliam Rosario====

Action Items:

  • Luke will ask Taha next week about what he can share with the cloud group
  • Luke, Matteo, Tony will try to meet this Friday
  • Crystal - draft agenda for March meeting
  • Crystal - mention possibility of session to discuss sharing of deliverables with entire audience of March meeting

Project Updates:
The Cloud: formulation of the framework of a deliverable is esablished and steps for populating components of the framework are in process
next need to make hard decisions regarding what to exclude from the framework - use CSS as a means of presenting to a larger audience, then focus on choosing particular components to focus on, perhaps have this discussion at the March meeting
there is currently a large amount of information that needs to be organized to make it intelligible and presentable
Luke has the cloud reference architecture available from Dr. Kass-Hout - Luke will ask Taha next week about what he can share with the cloud group
Luke, Matteo, Tony will try to meet this Friday

Metadata:
Glossary done by the end of January, review during Feb before meeting
How are deliverables shared? when is the appropriate time to share?
If want to publish iteratively and frequently - in addition to PhUSE blog, newsletter, monthly mailing - repositories for access by the public, possibly in addition to the PhUSE wiki, which has its limitations.
concerns about the wiki is that folks need to know where to look for things
Could use the CSS meeting for sharing - general challenge of making a deliverable into a long-lasting resource. a long term home.
Perhaps Pistoia - broadcasting, but perhaps not a long term home, Matteo has had some success with using them for building support
Perhaps also leveraging via CDISC

Semantic Technologies:
Representing CDISC standards in RDF - published with CDISC - roadmap for CDISC public review, finish within next 2-3 weeks
RDF representation of protocol representation in study design in SDM xml - working on draft, expect this to continue for next 4-6 weeks
in a recent meeting, demonstrated RDF elements and using web services in a browser
team working on SDTM and ADAM validation checks in RDF starting in January
might need to do a cleanup of the wiki soon - would be a good idea for all projects to update their wiki pages before the March meeting

Prep for March Meeting 2014:
Crystal will draft agenda and send via email before the Feb meeting
makes sense to break into seperate teams, depending on how many will travel to the meeting - project leaders will try to bring an esitmate of number of folks who plan to attend march meeting to our next ET meeting in February


December 4, 2013

====Attendees: Crystal Allard, Terek Peterson, Isabel de Zegher, Frederik Malfait, Anthony Hewer, Matteo DiTommaso, Steve Wilson====


Project Updates
Semantic Technologies:
Exiusting CDISC standards in RDF (Led by Scott Bahlavooni) group is working with CDISC to launch an official public review of SDTM in RDF in Jan/Feb 2014. Scott wants to finish this piece by next year to announce at the March meeting that CDSIC has reviewed the standard. Two additional new teams:
1) Representing CDISC conformance checks in RDF - plans to finish by first Quarter 2014
2) Representing RDF in xml - protocol representation - working with Dave Genzig - also meeting with folks from Transcelerate's new initiative to look at eProtocol representation. - project could go till middle of next year< br/> 3) Representing RDF around data analysis - from the statistician's point of veiw - kick-off in Jan. starting in Feb - Ian Fleming (D-wise)and Mark Anderson will lead

Metadata Definitions:
Three main topics:
1) Descriptive metadata and value level metadata - trying to liaise with the the first definers of terms and with the CDISC group
2) Controlled terminology - Meeting this week CDISC to discuss their stategy for managing controlled terminology and where some gaps may be in CDISC controlled terminology
3) Master data/reference data - document drafted by January to work on editing before the CSS meeting and send for review and get review for discussion at the meeting
Metadata E2E Management:

  • Will use definitions for this implementation document, but shouldn't start until terminology group's document is done
  • Terek needs to find volunteers - they seem to be focusing on SHare.
  • Perhaps reconsider the metadata repository project and kick-off this effort in collaboration with SHARE starting at the MArch CSS meeting

The Cloud:<br />

  • Use cases published on the wiki
  • Other deliverables promised
  • Mateo and Tony will meet soon to discuss the progress of the group. Seem to have good discussion and energy. Next steps are to identify high value deliverables and timelines for drafting them.

2. Steering Committee Items:

  • There is a planned pre-symposium webinar on 1/8/14 in which working group progress may be shared

August 14, 2013

Attendees:

1. Project Updates: The Cloud

  • Lead identified (from Metadata): Tony Hewer, Senior Director, Quality & Regulatory Affairs at Medidata Solutions Inc.
  • Matteo will continue to help find volunteers from PRISME and other sources, then hand leadership over to new co-lead(s). Between Matteo, John Wise (re. PRISME) and myself, we have a fairly sizable team right now (although I anticipate that the numbers will consolidate somewhat).
  • Still need FDA participation identified: I presently have your name, Crystal, in the list as well as Janet Gentry and Luther Dunlap.
  • Steve has discussed with Leaonard Sachs working with The Cloud goup. Leonard is working to understand the amount of work involved. - Steve?


July10, 2013, 10 am - 11 am ET

====Attendees:Frederick Malfait, Matteo Di Tommaso, Crystal Allard, Terek Peterson, Steve Wilson====

Action Items:

  • Crystal - FDA participant for Metadata Implementation Team
  • Crystal - Follow up with Janet Gentry and Luke Dunlap regarding possible participation in the Cloud PhUSE group
  • Steve - continue discussion with Leonard Sachs' eTeam about workign wtih "the Cloud" PhUSE group
  • Terek will send a blurb with a link requesting an industry co-lead to Chris Decker and Crystal Allard to add the PhUSE monthly mailing


The Cloud:

  • Possible Lead identified (from Metadata)
  • Matteo will continue to help find volunteers from PRISME and other sources, then hand leadership over to new co-lead(s)
  • Still need FDA participation identified.
  • Steve has discussed with Leaonard Sachs working with The Cloud goup. Leonard is working to understand the amount of work involved.
  • Crystal discussing with Dr. Taha Kass-Hout's (FDA CHIO) group to identify possible participant(s)

Semantic Tech:

  • 3 subteams (CDASH, SDTM, ADaM) have first working drafts
  • Working to set a date to finish the work near end of month,
  • Then take 2-ish weeks to consolidate the model. Perhaps put the common elemenets near the top.
  • Draft of three models finished by mid august.
  • Scott B working on a SEND model
  • CDISC is ready to consider taking ownership of the models.
  • SDTM IG assumptions will be incorporated into the model in the future.
  • Also, training sessions and Ontology editors are made available to team members
  • May start addressing new use cases mid August - could include conformance checks for SDTM and ADaM into RDF models.
  • Frederik also involved in CDISC share team - may potentially include RDF models produced with PhUSE collaborations
  • NCI published CDISC controlled terminology in RDF, used schema used in CDISC-to-RDF initiative which is part of the work being done in this PhUSE project

Metadata Management:
Terek

  • need FDA co-lead
  • working to identify industry co-lead also
  • Terek will send a blurb with a link requesting an industry co-lead to Chris Decker and Crystal Allard to add the PhUSE monthly mailing

Metadata Definitions:
- Isabelle

  • Work divided in 5 subtopic. We are almost at the end of metadata and gathered already input for part of the other topics

1. Metadata 2. Master data 3. Controlled terminology 4. Interoperability 5. Data aggregation, pooling, integration

  • Making progress – though takes more time than expected due to different understanding across the team and need to reach consensus; it is worth however to take the time on building that consensus
  • Advanced enough for the “implementation” team to start – several questions came in the definition project should be addressed in the implementation project

June 5, 2013, 9 am - 10 am ET

====Attendees:Frederick Malfait, Isabelle DeZegher, Steve Wilson, Lilliam Rosario Matteo Di Tommaso====

Action Items:

  • Crystal - Follow up with Scott B regarding whether the CDISC to RDF subteams need FDA participation
  • Crystal - FDA participant for Metadata Implementation Team
  • Matteo - write a request for co-leads and ask for a leader with a strong preference for a deliverable. Will update charter and send it with accompanying language to Chris Decker before June for inclusion in the July PhUSE newsletter
  • Crystal - Share Scientific Computing Board's white paper on "the Cloud'
  • Crystal - Follow up with Janet Gentry and Luke Dunlap regarding possible participation in the Cloud PhUSE group

Semantic Technologies Group:

  • Team was meeting weekly, is now meeting bi-weekly
  • approximately 40 people participating
  • 1st Use Case: CDISC in RDF
  • 5 subteams working to scope, stratify, create log files, and create RDF representations
  • plan to finish in 8-10 weeks
  • Landon Bain is CDISC liaison to Semantic Tech group
  • CDISC may agree on process for publishing and public review of CDISC to RDF representations

Metadata Definitions:

  • Team has met twice since March meeting
  • Team has approximately 12 people participating

Metadata Implementation:

  • Barry Cohen has been replaced as a co-lead by Terek Peterson
  • An FDA participant is still needed

The Cloud:

  • Approximately 20 people interested in participating
  • Some folks would like a 'map' deliverable while some folks believe this will add more complexity
  • Team needs leaders with clear preference for a deliverable