WG6 Tcon 1 Meeting minutes 04242012

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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