WG6 2013 Minutes

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Standards Roadmap Tcon

May 21, 2013

Attendance: Bob Dorsam, Anisa Scott, Debra Oetzman, Donna Danduone, Gitte Frausing, Rick Thompson

• Previous minutes have been posted on the wiki.
• Bob has reviewed the current version of the e-Paper and updated.

E-Paper Updates:
• Bob suggested organizing the e-Paper with:
o a Table of Contents at the top, with links that will take you to the various section of the e-Paper, and
o links to other sites, towards the end of the paper (“Links for Stakeholders”). Possibly add a statement at the beginning of the paper stating “For those new to these standards, there are links at the bottom of this e-Paper”

• Gitte has drafted the section “How to Move Forward with Standardization Effort”. This was forwarded to Bob during the meeting and was briefly reviewed on screen.

• Bob asked:
o “Where are the CMC/Chemistry folks in standardization efforts?”
o “Do they have any standardization efforts going on?”
o Is there a standard for transmitting a chemical structure?”
No one was aware of anything ongoing at this time.

• “Questions to Consider” section to be worked on over the next 2 weeks
• Gitte is still working on the “How to Move Forward….” section.
• Bob to start conclusion: End with “Standards Facilitation”

Of the planned 3 months to finalize the e-Paper, we have 1 month left. Need to complete so we can move on to other projects.

Action Items:
1. Need to update schedule of who is taking minutes for future meetings.
2. Bob to add hyperlinked Table of Contents and add Gitte’s text to current draft of e-Paper.
3. Everyone to review current draft and add comments. Do any sections need to be expanded on?
4. We will go through comments at the next meeting.



May 7, 2013

Standards Roadmap Tcon
May 7, 2013
Attendance: Gitte , Bob, Lynda, Donna, Anisa

Action Item Wrap-up:
Anisa created draft of Prioritization effort and created document for pre vious meeting minutes. Bob collated all sections of e-Paper into a most recent version and distributed to group.

A.I. Lynda and Debra will work together on the “Points to Consider” section.

e-Paper editing
-What is the best way to edit and finalize sections?
-Our experience from other working groups was shared, including:
- Donna offered that Word “comments” function can be used by all to edit a section. One person is tasked with compiling all comments and then the group gets consensus about a section by going through the comments on a Tcon
-Gitte offered that each section can have a point-person, and that one person should keep a view on consistency throughout the document.
-Bob offered that in another WG, the group would focus on one or two sections per Tcon to make it easy to focus the groups effort.

- A compilation of these approaches will be used:
- Each section has a point person to build it and oversee the changes from other members. People who make edits to any section, should do so using Tracked changes and Comments. The group will focus on one or two sections of the e-Paper in the upcoming Tcons for consensus and finality.


Putting “data gaps” aside as a topic and subject of the e-paper

The group discussed that the paper should stay a manageable, readable size.
- The current topic, “identifying data gaps and information gaps” has perceived value to the group, but it was mentioned that this topic may go beyond the scope of the paper.

-to prevent going down the rabbit hole, we decided to put “data gaps” aside as a topic and no longer consider it as a subject in the paper.

- One topic that has not been developed in the paper is “How to move forward with standards” The group will develop this section as a final section of the e-paper.

Gitte shared some thinking on this section. Established ontologies should be leveraged for standards, and it was acknowledged that the SEND CT team is working with INHAND. Additional resources must be leveraged for future standards, and more of this will be developed in this section of the epaper.

- A.I. Gitte will populate it with her ideas over the next two weeks.

-A.I. Bob will go through the paper as a whole document this week and make adjustments for clarity and consistency (via tracked changes)


April 23, 2013

Roadmap Telecon Meeting:
April 23, 2013 10:00 am
'Attendees: Bob Dorsam, Anisa Scott, Lynda Sands, Donna Danduone, Gitte Frausing, Rick Thompson

1. Bob asked for status update on e-Paper sections:

a. Introduction: Rick already submitted draft to group
b. Questions to Consider: Debra and Lynda discussing elements to include
c. Considerations for Implementation: Donna spoke with Gitte to address certain questions and get Gitte’s perspective. Donna sent a draft on Monday, 4/22 to Gitte
d. Links for Stakeholders: already well-populated, anyone feel free to add to this, possibly adding SEND FAQs?
e. Prioritization of Roadmap: Anisa will send out this week. There was a question about Figure 4 that will be a visual of the roadmap itself and what it should say about the standards and priorities. Should be a forward looking vision. This is TBD.

2. Bob examined data obtained from the surveys to ascertain if individual survey responses were significantly different from company responses.

a. Conclusion: There were only four responses from companies, which is not optimal for analysis. Nor did the companies rank every entry. In general, there was no significant departure. In some cases there was not complete agreement. e.g. Individuals listed pharmacology & safety pharmacology as high priority, but companies rated them as low/medium priority. Ultimately, decided that there is no need to perform an exhaustive analysis


3. From this discussion, it was discovered that the GSK company response, submitted by Lynda, was missing. Bob will follow-up. The Send button on Adobe Survey may be broken by some email systems. Unfortunately, it is too late to address this.

4. Data/Information Gaps

a. Study types: groups standardized according to prioritized list
i. Formulation/impurities information
ii. Electronic Certificate of Analyses
iii. Analyses and visualization of information
b. Information Gaps:
i. Study Data Reviewer’s Guide
ii. Compound Development Guide
c. There are SEND shortcomings when handling CMC data.
d. There is also Metadata and context for a study not currently captured in SEND.
e. Statistics, p-values, derived values, grouping summaries go in ADaM not SEND
f. Complete Package:
i. Allows context across studies
ii. Provides view that allows linkage between two studies
iii. Provides nonclinical overview
iv. How do we handle information that is humanly inferable to source data but not electronically?
v. Captures deviations analogous to DV domain in SDTM
vi. Comment: 129 variables in one dataset to describe a protocol is basically a very unstructured standard!
g. Bob will put ideas together and send out to team


March 28, 2013

28 March 2013

Attendees: Rick, Anisa, Lynda, Bob, Debra, Sara?

Regrets: Gitte, Donna, LouAnn

One new member: Donna from Instem


Will rotate minute taking. Create a schedule (See list below)


PhUSE take away: Work on small defined projects. Perhaps use a “divide and conquer” technique… Small group work; report back to group at next meeting.


PhUSE take away: Impressed with energy for and investment in topics and projects and teams. There were good discussions surrounding the report outs, and in the end, most groups staying on similar topics although perhaps refocusing efforts to something smaller or more defined.


Nonclinical will have two new groups:

Shree: Access to clinical and nonclinical data for testing purposes across the spectrum. If data were already available, it might be able to test theories or pilot more readily.

Sue D.: Study Reviewer’s Guide. Human readable overview of datasets. Leverage clinical templates to nonclinical.

Evaluation suggestions for Roadmap team from attendees:

  • Finish white paper.
  • Roadmap is in good shape. Remaining tweaking can/should be handled by SEND development team.
  • May increase number of domains available and force more data to be standardized.

Shall we see if we can improve the process for developing a domain or study type…a process map/template for standardizing any given domain? Standards facilitation group? Do a feasibility study on one to see if it would work. Think it through in the white paper first, then try it.

Action: Bob update the WIKI with current thinking


Continue with current meeting schedule. Tues at 10E, 9C

1. White paper: Finish in 3 months? publish?

a. Identify gaps

b. State vision

c. Standards facilitation

2. Identify test space/test process

a. Open forum – 2 months

b. Test space -3 months

3. Pilot test run w/model (exercise)

a. Via Shree

b. 2 months

4. Report out on how it went (deliverable)


How to go about doing a model for making a domain? What is the framework to use? Some folks on framework; some on testing space. Let’s not focus on getting data…someone else is working on it.


First draft on anything helps everything.


Domain development/test environment


Action Bob: introduce survey and feedback and figures

Action Rick: Move already written pieces around to get intro

Goal is end of June


Next meeting is: 09 April



Last revision by Dorsamr,05/22/2013