04-10-2014 minutes

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  • Sue DeHaven, Debra Oetzman, Bob Dorsam, Steve Polley and Nicola Robertson

Topics Discussed

  1. Introduction of new members
  2. Plan for continuing project activities
  3. Some additional notes


  1. Introduction of new members: Welcome to Steve Polley and Nicola Robertson, who are joining the team from GSK in UK. Both have extensive experience in Nonclinical Safety Assessment, Study Directing, CRO monitoring, data management and IT compliance for a range of nonclinical study types. They were alerted to the PhUSE Nonclinical Working Group and the SDRG project by Lynda Sands (thanks Lynda!) Both are deeply involved in SEND implementation at GSK, like many of us at our own employers.
  2. Plan for going forward: As documented in our CSS Poster, the team has made a recommendation to develop a specifically Nonclinical SDRG template, Guide plus Examples. We agreed to go forward as follows:
  • First, create a model nonclinical template, using the clinical template model as a start.
  • Second, work through the template section to develop the guide, each working with their own study sample as a reference. This is expected to help us develop a template and guide which will support varied situations.
  • Third, each team member (or company group) will apply the new template and guide to one common study, in order to see if we have developed something which can be interpreted consistently. Debra will investigate if there is a Covance R&D study available to use as our common study.
3. Other topics:
  • Sue has contacted the Clinical SDRG team to discuss how we can work together to maintain both the Clinical and Nonclinical SDRG packages consistently, and if possible maintain the production versions together on one WIKI site. FDA is already referencing the PhUSE wiki from the Technical Conformance guide, as a model. If we can post the Nonclinical package there as well, it would be a good place to provide it publically. Scott Bahlavooni, SDRG core team member, offered to schedule something for us to have this discussion (during week of April 14.)
  • Debra brought information from the April 9 SEND Core Team meeting, where there were comments on the Draft Guidances related to the need for a nonclinical SDRG. As part of our continued work, it was agreed we should continue to address this question directly in our Nonclinical SDRG Guide, providing our recommendation on when/why it is useful (a continuation of what was included in our poster.)