Nonclinical Core Team Minutes: 31 July 2015

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When: 31 July 2015
Place: Teleconference
Facilitator: Sue DeHaven and Bob Dorsam
Scribe: Bob Dorsam
Attendance: Sue DeHaven, Bob Dorsam, Mike Wasco, Sree Rayavarapu, Laura Kaufman, Bill Houser, Lou Ann Kramer

Agenda


  • CSS vs SOT contest
  • Response to Clinical SDRG review
  • Japan Survey project proposal
  • PhUSE 2015 Vienna – nonclinical session
  • What went well at CSS2015? Where are there opportunities for improvement in next CSS?
  • Tentative Quarterly meeting date?


General discussion


1. CSS 2016 and SOT: dates conflict

  • The venue is already planned and so the conflict in unfortunate but cannot be changed at this time
  • CSS2016 planning should incorporate people’s input (i.e. ideas, challenges, etc) prior to the CSS2016 so that it may be considered during the meeting

2. Response to clinical SDRG review Federal Register Notice

  • The PhUSE Nonclinical SDRG team may comment on the FR notice for the clinical SDRG, stating that the template is currently being modified to suit nonclinical studies
  • SDRG wiki will be updated so that the Nonclinical SDRG portion of the SDRG wiki site will include a comment that the nonclinical SDRG will undergo review under a separate process

3. Proposal for a new team to Survey the current status of SEND implementation across industry

  • SQA has a set of questions about SEND implementation and George asked for a survey to be distributed to PhUSE Listbox for input from PhUSE members
  • The Core Team generally thought that the survey was a good idea and so it has support to submit a new project proposal to the CSS Steering Committee
  • Prior work in SEND Implementation Team (poster presented CSS 2015) may be good supportive information and may not be overlap
  • Lou Ann will provide a bridge to between PhUSE and CDISC who has thought of similar questions and topics

4. The Quarterly meeting for nonclinical WG is slated for late September. The Update from that meeting will be used as groundwork for the Annual PhUSE meeting (Vienna) in October where the nonclinical WG has been asked for a 5-10 minute update on our progress.

5. Any Nonclinical WG members who will be at the Vienna meeting should reach out to Sue and Bob if they are willing to provide this brief updated at the meeting


Last revision by SusanDeHaven,07/31/2015