Best Practice Leadership Minutes 2014

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  • Assigning VISITNUM to Unplanned Visits and Assigning EPOCH to Observations
  • Standardizing Laboratory Units within a Sponsor/Submission -
  • Ensuring USUBID is Unique Within an Application
  • Conference Planning
  • Interest in continuing leadership or even taking on higher level role?


  • Lisa Lyons, Matthew Bryant, Monica Mattson, Natlia Smeljanski, Mark Sullivan, Trevor Mankus


•We need better promotion of the public review. Possibly at webinars a 5 minute this is what is available. Action: Lisa to follow-up with Chris/Scott with ideas.

Assigning VISITNUM to Unplanned Visits and Assigning EPOCH to Observations

  • Public review period is closed discuss status of review and addressing of posted comments – approximately 7 comments and team is discussing comments and will incorporate by end of February and repost to wiki. Trevor can post the replies to wiki.

Standardizing Laboratory Units within a Sponsor/Submission

  • Paper was posted Jan 21st and is open for public comment until March 1st
    Discuss general feedback (if any) - will discuss at the conference on Sunday and respond to any comments via wiki.
    Discuss status/plan to update wiki content – Meeting this Friday and Matt will check status. Lisa offered to update if team sends a Word doc.
    Other: Group has parking lot topics that could be assessed for future best practices. The test unit plan portion of the paper is of interest to the SDSP group. The two groups will meet at the conference to discuss transition. We will need document the agreements in the paper to tie the link to SDSP if that is the direction.

Ensuring USUBID is Unique Within an Application

  • Submitted to Steering committee/CDISC for review and feedback recently provided
    Discuss status of incorporating feedback and upcoming Webinar – Team meeting scheduled Feb 20th to address the comments. The plan is to post paper to wiki by end of February. Plans to discuss the paper among the CDISC leadership team at the conference.
    Exciting news (if you haven’t seen it) this paper will be part of a CDISC members only mini-training Webinar on Thursday, Feb 12th from 11:00am-12:30am EST – Mark, Gary Walker and Monica will present. CDISC reviewed slides and have given feedback. They want to ensure we emphasize it is a PhUSE WG paper and not a CDISC standard, but a proposal. Abstract submitted to have a poster at the PhUSE meeting.

Conference Planning

  • Action: Mike/Matt to look at notes from last year to see what additional topics we could consider/promote at the conference – Matt done.
    Everyone plans on attending and some will stay with best practices.

Interest in continuing leadership or even taking on higher level role?

  • Matt is interested in taking on the role. Anyone else interested in helping feel free to reach out to Mike, Lisa or Matt.
    Action: Lisa/Mike to send Matt’s name to DJ.



  • Share general feedback from group on draft documents
  • LAB Unit
  • Discuss timing to address comments
  • Discuss length of time for public review
  • Other


  • Lisa Lyons, Matthew Bryant, Monica Mattson, Natlia Smeljanski, Mark Sullivan


  • Next meeting will be week of Sept 22nd. Four weeks to give the USUBJID and Lab Unit teams time to incorporate the feedback.
  • Comments template spreadsheet will be used by each team to distribute the feedback back to all those who provided input. Leads will have their spreadsheets ready by the next meeting. Each lead will distribute the spreadsheets back to their respective team members/reviewers so they know the outcome.
  • General feedback from group on draft documents.

  • VISITNUM/EPOCH – Small cosmetic updates (page #s and consistent font size) and it is ready to send to Steering Committee for review. We will ask them to provide feedback before the Sept 11th Webinar so we can post to wiki. Lisa will see if it can be mentioned at the webinar we have this paper ready for public review. If we can’t meet this deadline we will ensure we post by end of September.
  • USUBJID – Monica/Mark are going to go back to the team to add actions for follow up with CDISC/FDA to try to get recommendations updated in the standards. They will also add FAQs for how people should handle in the interim since the recommendation right now is not consistent with existing standards and tools.

  • LAB Unit – No time to discuss. Please send any additional feedback to Matt using the comment template. He plans on addressing the feedback received so far with his team over next two meetings.

  • Discuss length of time for public review – Did not discuss length of time at the meeting.

Action Items

  • Lisa to set up next meeting in 4 weeks (Sept 24th) and follow-up if announcement can be made at Sept 11th webinar that VISITNUM/EPOCH is posted for public review.



  • Group Dynamic Issues
  • Sub team Update
  • Best Practice Document
  • Agenda for next lead meeting on June 11th


  • Mike Molter, Lisa Lyons, Mark Sullivan


  • Group Dynamic Issues

There has been some difficulty getting people to contribute, speak up at meetings. Group discussed following suggestions;

  • Agenda - Ensure agenda sent out in advance of meeting. Include action items from previous meeting to give people time to review and finalize their actions prior to the next meeting. Standing agenda item should be to review previous action items to hold people accountable and go over status.
  • Minutes - Consistent minute taker, which includes action items and responsible individuals. What has worked in past is having same person responsible for updating wiki takes minutes.
  • Wiki Updates - Ensure wiki it updated in timely manner with working files, meeting minutes, etc. This gives team central location as well as informs public on status of working group.
  • Best Practice Document"
    Steering Committee can accept all three documents on July 18th. They will discuss their comments at the July 25th meeting.
    It is suggested to have all Best Practice team members from each of the sub teams review each others drafts prior to sending to Steering committee. We should target mid-July. We will discuss at next meeting with other team leads.
    When getting ready to draft document, divide document into sections, make assignments and timelines.
    Link to BP data sizing document teams should use as a template


  • Agenda items for next lead meeting in 4 weeks
  • Group dynamics - hear from other sub team leads
  • Sub team update - provide high level update on content of document, discussion points issues. May help to prepare a few slides with high level content.
  • Discuss entire BP team review timeline of draft documents prior to sending to Steering Committee on July 18th.

Action Items

  • Mike to set up next meeting in 4 weeks (June 11th)



  • Introductions
  • Sub-Team Goal
  • Sub-Team Lead Meeting Purpose and Schedule
  • Wiki Training


  • Mike Molter, Lisa Lyons, Sascha Ahrweiler, Matt Bryant, Pawan Gupta, Unnat Patel, Michael Rubison, Natalia Smeljanski, Mark Sullivan


  • Member introductions
  • Sub-team Goal - Team discussed sub-team goal is to post draft document for public comment by July 31st to wiki. Requires PhUSE Steering Committee review prior to posting for public comment.
  • Sub-team lead meeting - Purpose to share progress, potential issues, etc. team will meet every 4 weeks on Wed from 9:30-10:30am EST. Leads will provide status update using the PhUSE Best Practice Project Status Report - Phuse-bp-project-status-report_2014MM.docx. This report will be provided to PhUSE Steerng Committee on regular basis to share project status.
  • Wiki Training - Sascha Ahrweiler provided high level training

Action Items

  • Mike to set up meeting every 4 weeks and create individual pages for each sub-team project
  • Lisa to find out when Steering Committee meets so teams can establish timelines to meet July 31st goal. Post Mtg Note: Steering Committee meets on the 2nd and 4th Friday of the month.
  • ALL - Create wiki account and send Sascha an email so he can assign admin rights.