WG6 2012 Minutes

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December 5,2012


Attendees: Sarah, Debra, Lynda, Anisa, Lou Ann, Gitte, and Bob

Action Item Wrap-up
ACT has approved distribution of the Survey but is still in-process (in active discussions with Robin Guy).
On SEND Wikipedia site, the group agreed that the best approach would be to add some primer text (possibly from the PhUSE Core Team DIA publication) along with links to the PhUSE WG6 content.

Path forward on Wikipedia content – as stated above, the group proposes to enter text onto the SEND Wikipedia site which includes primer text about PhUSE and a hyperlink to the PhUSE WG6 site.

Update on Surveys received thus far.
-Several aspects of the survey and Roadmap were discussed.

First, the group considered that we’ve received 11 surveys thus far. Because this is not a critical mass of feedback, the group will look at the current results and create a preliminary Roadmap that will be open for comment. This allows the group to create the Roadmap while giving others an opportunity to comment in the future. The group will post the Roadmap on the PhUSE Wiki and wishes to have a discussion thread below the Roadmap for public comment.

Second, the group will re-release the survey in early January to ACT, Gitte’s list from a recent meeting, and individual contacts that the group may have within industry. The release would be in early January with a deadline of January 25th, 2013. -So that people who’ve already responded aren’t confused by our second release, we will include text similar to the following:

- “Last chance! We are in the process of consolidating the responses from our 2012 survey on the Standardization Roadmap. If you would like to add your voice to this important topic, please fill out the survey and return by xxx.”

A.I. Bob will circulate an Excel spreadsheet to the group which contains the current survey results. He will also contact PhuSE administrators about the possibility of having Roadmap posted on the Wiki with an open comment area for public input.

A.I. Bob will update the dates on the survey (to be released in January) for the second release of the survey. The deadline will be adjusted to January 25th, 2013


Discussion: What is the last piece on the e-Paper?
We have intro, SEND resource information, survey results, and presumably thoughts that are fitting for a roadmap. Do we (for discussion):

-Provide a unifying perspective on the survey results (which studies, in what order, and why?)

- Identify challenges that need to be overcome?

- Issues once standards are done (i.e. Sender vs. receiver)

- Think of challenges that may lie ahead for standardizing nonclinical studies (i.e. what conventions exist in current standards that may not apply to future studies?)

- Think about “transformation” of standards?

Discussion: The group considered that we may need to invite experts for input on other standards. One goal of the paper could be to educate people about standards. Some of this final section could pose thoughts about challenges of standards. Actual resolutions to the challenges may be work for after the initial e-paper or the topic for another group’s work.

- The group will continue this discussion about the content in the final piece of the e-paper.

November 20, 2012

FDA/PhUSE Roadmap Tcon #15,
November 20, 2012

Attendees: Debra, Bob, Gitte, Anisa, Rick

Action Item Wrap-up:
The survey has been advertised on CDISC Newsletter, LinkedIN groups, and among a few WG6 teams. Posting among ACT members is in-process. Prior Minutes (and today's minutes) posted today.

Survey Distribution

- The deadline for the prioritization survey submission will be extended to Dec15th.

A.I. Bob will update the survey file to reflect the new deadline and will forward it to Rick for posting.

- The team did a summary of the recent efforts to distribute the prioritization survey to CDISC, LinkedIn, and the Interorganizational and Historical controls teams in WG6.

- The Roadmap group agreed that we should provide links to other team's work where relevant in the Roadmap e-paper.

-This will serve a dual purpose by eliminating duplication of work and providing resources for people new to standards (one of the group's desired functions for the e-paper)

Wikipedia discussion
-Members of the group noted that the SEND Wikipedia page is outdated. The group agreed that updating the SEND Wikipedia site with links to the PhUSE WG deliverables would be advantageous to getting the word out to data standards newcomers

A.I. Bob will engage Tim on posting WG6 material to the SEND Wikipedia page.

e-Paper
- The group took a look at our proposed sections for the e-Paper. Links to other WG efforts will be included as-needed.
- Introduction - providing our idea of optimized access to data
- As a first focus, it could set the stage for the rest of the work.
- Survey section (for a later date)
- Innovation section - approaches for transmission, submission, and review of data.
- Bob introduced this section as a place to offer innovative ideas to standardization (beyond our prioritization survey and SEND-specific matters).

-Gitte offered that one issue is how to align expectations of the sender and receiver of standardized data. Without mandatory domains or a defined set of basic data for each study, there is a potential for disparate data between studies. Perhaps not an issue specific to our group, it was thought that this could be a provocative thought in the e-paper and fruitful discussion for the WG6 (as a whole).

Bob agreed to bring this to Tim as a matter for WG6 to consider.

October 23, 2012

PhUSE WG6 Standards Roadmap Tcon 13
October, 23 2012
Attendees: Anisa, Bob, Debra, Lynda

Action Items Round Up - Final version of pdf form (v 10) sent to group. Form is posted on Wiki.

Agenda

Prioritization PDF Form – Launch today
a. Quick run through for the team to look at the current link to Survey.
b. The Prioritization Survey.pdf, intro text, links and Wiki posting are tested and read to go.

c. Bob will send emails to Lou Anne and Tim for survey dissemination. We should all try to get the survey out.

A.I. Based on discussion, the juvenile (offspring) field in the Prioritization Form V10 must be updated to red text (“under development”) rather than its current blue font. Bob will contact Tim and Lou Ann for dissemination of the Prioritization Survey. Post-meeting note: Bob contacted both Tim and Lou Ann for launching the survey on Wed, Oct. 24, 2012.

Members are encouraged to disseminate the form as widely as possible.


Paper –now our sole focus
a. Concept of study types prioritized with threads to flow across study types, enabling meta. What is our experience with this, and other data management principles? Does it stop at nonclinical study types, or can we think of themes that build towards clinical? General call for SMEs that may help with vision/examples which we can adapt for the ePaper? (some may be in our group)


Discussion on the items above for the e-paper was limited. All members should be thinking of the data challenges of their current work as potential source content for the e-Paper. Members are encouraged to maintain a list over the next two weeks for compilation/discussion at the next Tcon (11/6/12).

October 9, 2012

Tcon 12, PhUSE Standards Roadmap Group. October 9, 2012
Attendance: Sarah, Anisa, Gitte, Rick, Bob

Agenda

Action Item Wrap-up: Tcon 11 minutes posted, E-paper sections are on Wiki Discussion Tab, Gitte’s 4-5 sentence blurb completed. In a last call for edits, no members indicated that further edits were necessary

Launch Prioritization form

The group discussed final moves to launch the form. The following issues were resolved:

-Currently, we envision the 4 sentence blurb (invitation to complete the survey) in an email that will have a link which directs them to our Wiki.

- The group must prepare the Wiki for user-friendly access. The front of our Wiki will have a simple greeting at the top of the page with a link that opens the survey form.

A.I. Bob and Rick will figure out the posting of the form to the Wiki and pilot the form through submission to the Phuse email address (which cc’s Gitte’s email address)

-The group discussed that the survey/pdf form has the extended intro text prior to the survey. We agreed that the extended text would be put at the end of the document with a brief mention of that text in the Directions that are currently at the top of the survey form.

-Group agreed that November 30th is the new deadline for respondants.

A.I. Bob will update the form to reflect the new deadline.


Contact Tim, Lilliam, Lou Ann with the form for distribution.

A.I. Bob will contact them once we have the Survey posted on the Wiki.


It was discussed that each member should think about how they will represent their company's or Agency's perspective on the current form


E-Paper

- Though the e-Paper is currently on Wiki Discussion Tab, the group agreed to work offline in Word documents with Tracked Changes and cc’s to everyone when a section has updated content.

A.I. Bob will post the skeletal topics for the e-paper into a Word document and distribute to all members. They should place it on their desktop, and begin populating content.


- Some members began volunteering for sections to populate pieces with text or content, -Bob will undertake content regarding FDA policy on Data Standards, -Gitte volunteered to contribute content about considerations for implementation, and links for further reference. - In a previous discussion, it is believed that Debra may have volunteered for adding content to Questions #1 and #2 in “Questions to Consider” section

- Discussion on how to represent the Roadmap. Some ideas were discussed including: graphical and chronological/ Section to discuss elements outside of study types / tabular with % of responses as high, med, low for any study type. - During the discussion it was felt that we may need to see the nature of the data that we obtain from the survey before deciding on a visual representation.

- Still, the group discussed that a prioritized list of study types could be one representation, and further agreed that assigning actual “dates for completion” to such a list was not reasonable for this group.

- It was also discussed that Study Types may very well belong on a different priority list than Study Elements. The Study Elements may serve as “threads” which several study types may use in order to improve access to each Study Type.


September 25, 2012

Roadmap Tcon 11. September 25, 2012

Attendees: Rick, Debra, Sarah, Gitte, Bob, Anisa


Form distribution
The group discussed ways to distribute the Prioritization Form.

Currently, the group see Linked In groups and Working Group 6 members as forums for distribution.

-Members of the Roadmap group suggested that each LinkedIn group may be run a bit differently. The conclusion is that we will rely upon Lou Ann to distribute the form through her groups to groups that are receptive audiences.

- Tim and Lilliam will be contacted regarding distribution throughout Working Group 6

-Gitte will distribute to her Tox network.


A.I. Bob will contact Tim and Lilliam to indicate that the form is coming, and to see if they have any suggestions on our current plan for dissemination to WG6. Will discuss whether the form (mentioned below) will be on WG6 Wiki or on the Roadmap Wiki?


The group now envisions a 4-5 sentence blurb to get people’s attention, along with a link that will lead to the form. The form will consist of the Intro Text and Prioritization form in single document.

A.I. Gitte volunteered to draft the 4 to 5 sentence blurb

A.I. Bob will place the intro text into the Prioritization Form and distribute to group.


e-Paper

The Roadmap Wiki Discussion Tab will be populated with a new banner where we will collect content for the e-paper.

- A.I. Bob will set up the banner, and populate it with “Questions to Consider.” All members will populate with the initial content.


Initial content for e-Paper includes :

1) The “Questions to consider”, drafted by Debra. Members will use these questions as guides for providing information about Standards efforts.

2) Keywords section that will prompt ideas about more content.

3) Considerations to implement standards (partially provided by Gitte)

4) A series of links to orient stakeholders about Standards, and relevant resources.

5) The group’s concept of the Roadmap for Nonclinical Data, and results of the Prioritization Survey.
To view and add content to e-Paper, click on the link below:
http://www.phusewiki.org/wiki/index.php?title=Talk:WG6_Nonclinical_-_Standardization_Roadmap#Intro_for_prioritzation_exercise


August 29, 2012

Standards Roadmap Tcon #9 August 28, 2012

Member Attended? (x=yes)
Gitte Frausing, Novo Nordisk X
Bob Dorsam, FDA X
Alain Nanzer, Roche
Deborah Sholtes, FDA
Lou Ann Kramer, Eli Lilly X
Jerker Ringstrom, SixSteps AB
Geoff Mann, SAS Institute
John Anderson, Novo Nordisk
Natalia Smeljanski, Merck
Lynda Sands, GlaxoSmithKline
Debra Oetzman, Covance X
Sarah Obbers, Janssen Research & Development X
Anisa Scott, SAS Institute X
Rick Thompson X
Other

Agenda

Pdf Prioritization Document

- Bob showed the current form which reflects all suggestions to-date.

- Upon viewing the form (Version 6), the group accepted the overall appearance of the pdf form. All elements of voting, submission by email,and compilation into a single spreadsheet have been tested and validated.


- Edits were suggested, including: minor edits to directions at top of form, deleting repeated cells at bottom of page 2, update CV and respiratory safety pharm as “under development”


- The group agreed that a 45 day period for returning the form was the most practical deadline for responses.


A.I. Bob will circulate the form with all suggested updates (V 7)


- Viewing the Excel sheet which is the compiled output from all responses

- The spreadsheet with combined data appears acceptable to the group. One comment was on the numeric coding of individual vs. company responses. A more accurate text representation will be accomplished in an updated form.
-Bob mentioned that the survey responses will have to be placed into context of our group’s inclinations about the Roadmap.

Introduction text

- Status: The PhUSE site can facilitate Word document archiving along with Version tracking. To date, there doesn’t appear to be a “check out” feature which would prevent parallel edits.
- With some testing, Rick and Bob gathered a few things about PhUSE Wiki version tracking – A user must be logged in to upload a document, and it seems that they must log out before seeing the changes reflected in the updated version.
-The group decided that the edits to the Introduction Text were not significant enough to warrant such version tracking. Edits will be done via email

A.I. Rick will distribute the Word Document containing the Intro text in a subsequent email.
A.I. All members should read and edit the Intro this week. Please send the edits back to Rick with a cc the group.
Goal is to finish this week, unless substantial edits require discussion.

E-paper

- Discussing initiation and general organization of this project

-Group agreed that this e-paper would provide context to the Prioritization exercise and standardization directory.


Topics that may be included in e-Paper:

  • Why standardization at all? What are benefits?
  • Who are points of contact for standardization efforts?
  • How can people contribute to standardization (creating SENDIG pieces, sending test data, piloting)
  • Inclusion of directory of Standardization efforts, possibly with a recognition that the directory will be a snapshot for a document that is otherwise intended to be dynamic


-Part of the group discussion veered toward a need for consistant Agency involvement and encouragement of processes of standardization.
After the meeting, Bob conveyed this sentiment to Tim Kropp.
-The group suggested that the long-standing efforts to standardize may be further catalyzed by a gesture such as publication of the group’s Standards Roadmap on the Agency’s webpage.
-Bob will pursue whether this is in the realm of possibility once the project nears a more final product.
After-meeting note: perhaps the paper might include references to legislation and guidance which establishes the Agency’s commitment.

- Organizing our effort on e-Paper: The group discussed establishing focal efforts on topics based on our varied backgrounds. The topic was left open for further development.


August 15, 2012

Standards Roadmap Tcon #8 August 14, 2012

Member Attended? (x=yes)
Gitte Frausing, Novo Nordisk
Bob Dorsam, FDA X
Alain Nanzer, Roche
Deborah Sholtes, FDA
Lou Ann Kramer, Eli Lilly X
Jerker Ringstrom, SixSteps AB
Geoff Mann, SAS Institute
John Anderson, Novo Nordisk
Natalia Smeljanski, Merck
Lynda Sands, GlaxoSmithKline X
Debra Oetzman, Covance X
Sarah Obbers, Janssen Research & Development X
Anisa Scott, SAS Institute X
Rick Thompson X
Other

Action Items Wrap-up: Meeting minutes for Tcon 7 posted today. Prioritization Sheet pdf Version 2 circulated. Introduction text under review.

Discussion:
Core T
eam members published a call-for-participation.
Article posted Aug 9th, in DIJ (DIA journal) for the PhUSE group Call-for participation:

http://dij.sagepub.com/content/early/2012/08/09/0092861512456839

Rick indicated that an internal presentation about PhUSE elicited a question about what expertise is desired for Working Group 6 participants. Multiple members offered that people from diverse backgrounds are needed to achieve multiple perspectives. It was noted that a broad overview of potential backgrounds of participants is listed on each team’s Wiki.


1) Discuss the Introduction text for the Prioritization Exercise

- Please look at it and provide edits prior to our call. http://www.phusewiki.org/wiki/index.php?title=Talk:WG6_Nonclinical_- _Standardization_Roadmap

- Is sharing the document via email preferred? Group consensus is “yes”

- Discuss content. We are looking to provide context in the simplest way possible. We want to give respondents some direction, but keep their minds open because we might very well gain from their less-structured feedback.

- Update intro to reflect pdf format, remove mention of column b, c, g, etc.

Meeting discussion: - Many members offered that the content of the draft intro was well conceived.

- The group would like to proofread and edit the Intro in a Word document rather than on Wiki. Tracked Changes and familiarity were cited as reasons to adopt the more traditional editing process. The downside is that emailing the Word document introduces the potential for editing an obsolete version. With version tracking in mind, the group discussed Google Documents as a potential forum to help track versions.


A.I. Rick will look into Google documents as a forum for finalizing the introduction Word document.


A.I. Intro will be developed off-line by the following volunteering members via email and possibly Google documents
-Bob, Lou Ann, Debra, Rick, Anisa, Lynda, Gitte


Meeting discussion: - Intro should reflect the fact that the respondents will be using the pdf form, thus necessitating a removal of current mention of columns b, c, etc.
-Intro should mention idea of scoring only study headings (i.e. Toxicology) vs. Study types (single or repeat dose tox studies). Respondents may lump studies together by scoring headings, but some may score individual study types (splitters). Mention of these two approaches may be addressed in the intro.

- The group discussed whether we want individuals to respond, or rather a single response from an entire company. The feeling was that getting a company’s input would be of value for their potentially broad perspective. Still, all-comers are welcome. Also, advice should be given to a point-person in each company as it is expected that a unified voice requires one person to collate the response. Intro may include approaches to getting a consensus view for a company (i.e. averaging data along with leadership concurrence). -Consensus was gained that our pdf prioritization sheet should indicate whether someone answering as an individual or as a company.


2) The Prioritization Exercise pdf (circulated prior to our call for your comment) - Incorporated color-code, Columns, and Open Comments field. Other suggestions?

-Discussion points:

- General comments that sheet had a decent appearance, though it is still open for adjustment

- Need a “Name of Respondent section” and check box should be incorporated to indicate if response is from individuals vs. companies

- eCTD numbering should be moved to a separate column for ease-of-reading

- Priority scores should be placed in all major headings to accomodate lumpers vs. splitters. Lumping a score or splitting priorities of study types should be addressed in introductory text

- Font bigger in Comment section text field

- Assistance needed for testing of sheet. i.e. Submit Email Button


A.I. Volunteering members (Rick, Debra, Bob, Anisa, Lou Ann, Gitte) will be included in email string for pdf version-testing and validation.
Bob will circulate Version 3 (reflecting all upgrades) for testing and comment


3) Discuss the concept of forming two small off-line groups for getting these two items finalized

- Meeting discussion: this approach was accepted and the volunteers for our two items (intro text and prioritization pdf form) are listed above.


4) Next steps

- Introductory text development:
Volunteer group works offline via email and Google documents. Goal for finishing not discussed (Post meeting note: Consider a goal of two weeks from now)

- Pdf version testing and validation – Bob will circulate version 3 for testing. Volunteergroup provides testing and feedback

-Tcon on August 28th


July 31, 2012

Standardization Roadmap Team Tcon # 7 July 31, 2012, 10 am EST
Attendance:

Member Attended? (x=yes)
Gitte Frausing, Novo Nordisk X
Bob Dorsam, FDA X
Alain Nanzer, Roche
Deborah Sholtes, FDA
Lou Ann Kramer, Eli Lilly
Jerker Ringstrom, SixSteps AB
Geoff Mann, SAS Institute
John Anderson, Novo Nordisk
Natalia Smeljanski, Merck
Lynda Sands, GlaxoSmithKline X
Debra Oetzman, Covance X
Sarah Obbers, Janssen Research & Development X
Anisa Scott, SAS institute X
Rick Thompson, Janssen Research & Development X
Other

The group welcomed Rick and Anisa.
A brief overview of the group’s intent and work plan were given, and each member provided a brief overview of their background.

Consensus on elements of the Prioritization Sheet (pdf form)

1) The group viewed an in-process draft of the pdf version of the prioritization exercise for eventual posting on the Wiki. Previously, consensus was gained that we need to make the exercise simple to distribute,fill-out, and compile. A pdf version of the list is in the process of being made by Bob and he showed the current (incomplete) version to the group via Abode connect

- The group agreed on three columns (Study Type, Priority Score, and Rationale). Drop-down lists were preferred for the prioritization score, and null fields should be allowed for this column.
Open text was preferred for the rationale column (perhaps with an “i.e. use in submission” as an example in top of rationale column
-Sheet will have color-coding so that study types that are standardized will be in blue, and study types that are currently being standardized will be red. All other study types will be black font. This is intended to convey prior and current standardization efforts to those who are filling out the sheet.

-Discussion was to post the PDF on the Wiki, and provide info so that people could request the list via email (presumably the same format as is posted on Wiki for ease of compiling final data) al data.)

Discussion about Prioritization Introduction text

Debra contributed the draft Intro, which was loaded onto the Wiki for comments and edits by the group.

-Intro will be tweaked to describe the pdf document (including null, color-coding, etc.) including the points of consensus that were reached in this meeting (above).

-Consensus that the sheet should have an open field at the bottom of the sheet, intended to accept all comments about the roadmap and elements of data utility.

- If the pdf version of the prioritization sheet doesn’t work for some reason, the group discussed that Survey Monkey may be an alternative to explore.

A.I. Bob will finish working-up the first draft of the pdf sheet and distribute it to the group before the next meeting.

A.I. All members should view the Intro (Discussion Tab of Wiki) and edit for the final product.



July 24, 2012


Standardization Roadmap Team Tcon # 6 July 24, 2012, 10 am EST
Attendance:

Member Attended? (x=yes)
Gitte Frausing, Novo Nordisk X
Bob Dorsam, FDA X
Alain Nanzer, Roche
Deborah Sholtes, FDA
Lou Ann Kramer, Eli Lilly X
Jerker Ringstrom, SixSteps AB
Geoff Mann, SAS Institute X
John Anderson, Novo Nordisk
Natalia Smeljanski, Merck
Lynda Sands, GlaxoSmithKline
Debra Oetzman, Covance X
Sarah Obbers, Janssen Research & Development
Other

Action Item re-cap:

  • Tim agreed to provide a conduit for wider distribution of the prioritization exercise.
  • Gitte determined that we can post the prioritization sheet on the Wiki. It appears that the Wiki doesn’t support Excel sheets, so a pdf solution will be tested (see below).


1. Updates on member's efforts to get prioritization from their companies. Discuss approaches, problems, and solutions.

Discussion:' Debra shared that it was time-consuming to provide context to the exercise during a meeting where she was getting feedback. Consensus was reached that an introductory document would be beneficial to properly frame the exercise.


2. Discuss feedback from Core Team Evaluation...
Core team input: Goal can be to get input on the prioritization exercise from a wider audience

  • Tim and Lilliam will help us to access PhUSE working group.
  • CDISC/SEND distribution can be accomplished through Lou Ann and Gitte.
  • Social networking groups can be accessed via Lou Anne.


Core Team input: How we frame the exercise is important... It could affect the feedback. Members of the core team suggested to aim for prioritization of data utility/accessibility
Proposed: form a small group to get a draft intro together. Some concept that might be included:

  • Intro to problem of data inaccessibility
  • Informatics solutions for improved data access
  • Intro to our group, our purpose. (helpful material may be on Wiki)
  • Explain prioritization exercise and its goal
    • Leaving the responders some freedom to identify their own priorities (even outside of current context of data standardziation)



A.I. – Debra volunteered to start a draft of the Intro document. The group agreed to edit and comment on the document on the team’s Wiki page. Debra will circulate an email to let us know when the first draft has been posted on the Wiki.

Gitte indicated that the Excel prioritization sheet may not be a supported format on the Wiki. A pdf form of the sheet will be tested as a workaround, so that everyone who wants to provide feedback can do so by downloading this sheet (in pdf format)

A.I. Bob will try to work up a pdf sheet based from the current Excel sheet.

Core Team Input: Consider providing metrics on the nature of group’s responses. Is there a pattern that could crystallize an effort among a subset of respondents? This comment will be kept in mind as we collect feedback.

Bob mentioned that we should maintain awareness of other teams activities. The Interconnectivity Team data sheet (with many study types) was circulated to the group. Post-meeting note: This may provide some inspiration as we consider the full extent of nonclinical development in the roadmap and e-paper.

Post-meeting A.I. Bob should provide our new member Anisa Scott with onboarding material

Our plan is to formulate the intro for the prioritization sheet over the next week and get detailed input by the end of the next meeting for finalization. The pdf version of the sheet should be worked on in parallel so that both the intro and sheet are ready for distribution by August 3rd (a s a goal).

Our next meeting will be held next Tuesday


July 2, 2012


Standardization Roadmap Team Tcon # 5 July 2, 2012, 10 am EST
Attendance:

Member Attended? (x=yes)
Gitte Frausing, Novo Nordisk X
Bob Dorsam, FDA X
Alain Nanzer, Roche
Deborah Sholtes, FDA
Lou Ann Kramer, Eli Lilly
Jerker Ringstrom, SixSteps AB
Geoff Mann, SAS Institute
John Anderson, Novo Nordisk
Natalia Smeljanski, Merck
Lynda Sands, GlaxoSmithKline X
Debra Oetzman, Covance X
Sarah Obbers, Janssen Research & Development
Other


Agenda: Discuss the Roadmap Prioritization Effort

  • Those in attendance shared the current state of their individual efforts to obtain input on the prioritization list.
    Members were at varying levels of completing the prioritization task. More time is necessary to get company feedback from all members. The Roadmap will be finalized later in the summer. All members should actively pursue feedback from companies if they have not already done so.

-Bob and Gitte shared their finalized prioritization lists
-Some rationales underlying individual’s prioritization were discussed. Members should capture these on their worksheets for potential use when constructing the e-paper.
-Post meeting note: Though the Roadmap will be finalized toward the end of summer, members should be on the lookout for subject matter experts for each part of the roadmap

  • The group agreed on an effort to compile all company/Agency feedback into a single worksheet.


A.I.'Bob will compile prioritization data from members.

-All members should send your company’s prioritization worksheet to Bob with a cc to Gitte.


  • The group agreed that company identities would remain anonymous when compiling data. Identities would be used only in a case where a clarification was necessary.
  • Gitte suggested that we seek input on the prioritization list from other members of Working Group 6.

Bob will contact Tim for feasibility.

  • Gitte suggested that a blank template of the worksheet should be posted on the Wiki for companies to provide input.

A.I. Gitte will contact PhUSE about posting this file to the Wiki and post the sheet.


The group agreed that, due to member’s vacations, the next meeting will be held on Tuesday, July 24th at our regular time (10 am EST). Bob will send an Outlook Invite to the group.


June 5, 2012

PhUSE Standards Roadmap Tcon #3 - June 5th, 2012


Attendees: ALain, Bob, Geoff, Lou Anne, Lynda


Action Items Wrap-up:

Posted prior meeting minutes; Concept of Data, Storage, and Context (placeholders) added to Wiki Discussion Tab; Drafted the Welcome Letter for new participants;General solicitation for participation at FDA in roughly two weeks.

A.I. Bob will distribute the drafted Welcome Letter for general comment. We discussed trying to keep it simple since some information is on the Wiki.

Proposed Discussion

  • Approach on e-Paper

**How to focus initially

*** Guided by studies list (as resource while avoiding duplication)

  • Aim to prioritize elements and to characterize what factored into prioritization. Brainstorm on additional elements (toward data accessibility, storage)

**First steps: obtain feedback from your company over next two weeks.

** Have drafted list with

*Leave room for back-fill from other groups’ work
How to proceed

*Need smaller pieces with some approximate order, then go stepwise

Discussion at meeting-
The group briefly discussed how the proposed e-Paper could serve as an overarching document that gives context to the standards roadmap and standards directory.


The group discussed how to proceed for the next months... Using the SEND Roadmap Planning list (courtesy of Gitte, distributed by Bob), each member will take the studies list back to their companies to construct their own prioritized list. The idea is to prioritize the list of studies but also capture the rationale for choosing that order. We’ll share our lists and reasoning behind our list at our July 3rd meeting. These will serve as a foundation for the group to obtain a consensus list. Once we have a consensus list, we should consider whether we have scientists who can serve as subject matter experts who might add elements that we should consider when developing and finalizing our list. The idea is then to go down the list step-wise to consider whether each element on the list needs to be further developed. It is expected that this step-wise treatment will be conducted over several TCs. Some studies may be grouped and discussed at a single Tcon, while it is conceivable that a single study type may garner greater discussion, especially if we’ve invited a subject matter expert.


It was mentioned that the intro of the e-Paper may be easy enough to define, and that our roadmap prioritization exercise will likely spin off issues that can be developed in the e-Paper. This e-paper development can conceivably take place during our roadmap discussion, with greater focus on achieving an acceptable version of the e-Paper after our Roadmap discussions have run their course.

A.I. Bob distributes SEND Roadmap planning list

A.I. All: please use the studies list to develop a priorities list with your companies for discussion at July 3rd meeting


May 8, 2012

PhUSE Standards Roadmap Tcon #2 - May 8th, 2012


Attendees: Gitte, Jerger, Bob, Lynda, Alain, Tim

Action Items Wrap-up:

Posted prior meeting minutes; Sent recurring Invite for Tcon; Established a consistant Tcon phone number; Connect Pro account set-up
Member-built roadmap pieces; Viewed Therapeutic Area Standard Roadmap; Feedback from your company about their priorities of standardization?
Discussion -
-Gitte: A noted concern was raised from members in one company about pharmacology data, saying that systems are already up. There was a feeling that studies are unique and defy standardization. i.e. Anesthetized animal, a GI dose for exposure. How is this captured? In vivo, ex vivo may cause difficulties.
- Balance necessary between data captured and catching study conditions (design) for appropriate context.
- Can a general standard be suggested for pharmacology studies?
- Can a system for trial design be bolstered? There was a recognition that standards for study design currently leave gaps. These study design gaps are a challenge to accurately capturing studies in a standardized format.
- Idea for a case study: Need to get a fixed set of study designs to identify their gaps.
- Discussion that pharmacology may not be a first element of safety signal, but will still help to support the robust development of drugs.
Lynda: Her group expressed an interest in genetox (in general). - Idea was to look at the established predictive tools for genetox to see if there is anything to gain in standardization.

Agenda

Tim Kropp: Grasping “Data Accessibility”
* Data Usability
**User accesses data in most efficient way possible
***Access – looking at it with multiple tools, proper training, etc.
***Data Storage – tabs on it, accessible to the tools.
*Later discussion was held about the “concept of data” where raw, operational, or submission data all have different forms and uses. The needs for each type of data should guide the rules that govern it. Discussion Tab will be opened to explore the “concept of data”
**Data seen in context – for interpretation (granular vs. total submission), i.e. data gained with a particular drug lot,
**Efforts started with data standardization
- To get it in and warehouse it, we developed tools. It is not the endpoint, but enables our access.
- To prioritize data standardization, but expand thoughts on how to better access data (storage, context solutions).
-Standardization is time consuming. How can we get prime data for best meta-data evaluation?

    • Concept of Data:

Data comes in different forms: Raw data, captured data (GLP), operational, data in a repository for analysis. These are different than submission data for regulatory purposes. Submission data is a final from some perspectives, and seen as elemental building blocks to a reviewer.
***Explore how need from data defines the rules around the data.

A.I. – This concept can use a String in our discussion tab.

**Solutions for data accessibility may be software, possibly evolve standardization efforts. Considering novel approaches. Some studies are easily standardized (genetox), but other elements may need more consideration (meta).

View of Wiki: Progress in the past two weeks
Does Tim’s perspective give us ideas of where we can expand our list? Yes.
A.I. -Bob will populate Wiki Discussion Tab with Bulleted points for Storage and Data Context for further expansion.
A.I. Members should freely add to these Discussion Strings on wiki.

Discussion – How does the Therapeutic Area Data Standards Roadmap affect our ideas of the nonclinical roadmap?
Ongoing discussion *Difficulties in being prescriptive about specific pharmacology studies (example) for submission.
*Clinical Therapeutic Area Roadmap – Defined by clinicians in ongoing effort. Retrofitting the terminology to nonclinical pharmacology studies would be a challenge. Can one indication between nonclinical and clinical (Case study) be an exercise to explore this?
Jerger suggests an invitation to Eslie Dennis as a translational researcher (Clinical Path Initiative) to address how nonclinical and clinical areas may find overlap.
A.I. Jerger contact Eslie Dennis for future discussion.


  • Organic Agenda Setting - Can it be seeded on Wiki and built during the two weeks prior to the Tcon?

**General acceptance by the group

Call for participation *Draft a welcome email to future participants (borrowed from Endpoint Pred. group)

		**A.I. Bob, Alain, Gitte: Drafting Welcome letter. Bob will forward a (very) rough draft.

***Elements: Welcome, Wiki link, Outlook meeting invite, Tcon details, Connect Pro Link...
*Recruiting: Ask someone you know to participate
**discussions during the Tcon, Jerger said he may recruit a database specialist to the group. Lynda may have an interested person who is currently probing the Wiki. Bob has extended an invitation also and is awaiting response.


April 24, 2012

PhUSE Roadmap Tcon #1 Meeting Minutes, April 24, 2012

Attendees: Jerger, Gitte, Bob, Geoff, Sergio, Lynda, Alain

Subjects: Group Communications, Wiki, and Call for Participation

Communications

  • Meeting Minutes
    • Consensus: Minutes recorded by host during the meeting.
    • Agenda prior to meeting should optimally include bulleted points for ease of discussion – the group could conceivably reach consensus immediately on a bulleted point, although issues should not be strictly limited to the predetermined bullet points.
    • Minutes should be posted on Wiki for general viewing, and not be circulated by email.
  • Tcons
    • Date and Time: 10 am EST every other Tuesday starting April 24th.
    • Consensus that we need flexibility in the future as need by participants.
    • Phone Number: Consensus that we need a permanent call number for consistency. Skype is not permitted by some companies and thus does not appear to be a viable option.

Action Item (A.I.) – Bob to explore FDA-sponsored Tcon #. In the event that FDA cannot sponsor calls, then a powownow # will be identified. Bob will explore mechanism to get a WebConnect Account.


Wiki

  • All on-board? All members indicated that they have created Wiki accounts.
  • Wiki serves as a means of brainstorming, compiling our work.
  • The group did a walk-through of Wiki Frontpage and Discussion Tab
    • Look into making a slide for CDISC SEND Roadmap and posting on Wiki (Bob will look into this) and eventual HyperLink to CDISC Website. Bob notes that when updating content on Wiki, there is a button to upload a file (presumably a jpg or ppt) which may be the way to post the CDISC SEND slide
      • CDISC SEND product for posting likely to materialize after the May 2012 Face-to-Face
  • Gitte indicated that FDA has defined Clinical Therapeutic Area Data Standards Roadmap and this might be a template for how to proceed with our own priorities.

Link:http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM297084.pdf

  • Gitte provided link and next meeting (May 8th) we will discuss how it synchronizes with our current understanding of our group’s tasks and plans.

A.I. - Participants go back to companies to understand needs for standardization of study types.
A.I – Participants should populate the Roadmap Elements (under Discussion Tab) with pieces that belong on the Roadmap. The Challenge/Vision statement may serve as some inspiration. '
A.I. -Team members should view the link above and consider how the Clinical Roadmap may be used to help us prioritize. Discuss at next meeting.

Call for Participation

  • Discussed minimum requirements from Core Team
    • Group needs to update target participants on Wiki, but realized it is important not to be overly exclusive.
    • Wiki must identify the minimum requirements (time) for participation in the group.
    • General Co-Lead Tcon on April 27 will serve as a deadline to be ready for the call-for-participation. Gitte and Bob to update Wiki in preparation of this call.

A.I. Bob sends out invite for next Tcon on May 8
A.I. Bob will ask Tim about Lynda’s Wiki Permissions

Complied Action Items:
1. All Members: Go back to companies to understand needs for standardization of study types. Responses can be reflected in the Roadmap Elements on the Wiki.
2. All Members: Participants should populate the Roadmap Elements (under Discussion Tab) with pieces that belong on the Roadmap. The Challenge/Vision statement may provide inspiration.
3. All Members: View Clinical Therapeutic Area Data Standards Roadmap for our next meeting’s discussion on how this might help us prioritize pieces of our roadmap. Gitte has already provided link above.
4. Bob explores FDA-sponsored Tcon number and WebConnect account. If this is not an option, a Powownow number will be established by next meeting. Bob sends invite for May 8th meeting (10 am) and asks Tim about Lynda’s “edit-permission” on Wiki. Also look into posting a slide on Wiki for CDISC SEND Roadmap.

Next meeting is May 8th at 10am. Invite to follow







Last revision by DanBoisvert,05/14/2013