Data Standards Monthly Project Lead 19 August 2019 Meeting Minutes

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  • Project team updates


  • Aatiya Zaidi
  • Aimee Basile
  • Amy Palmer
  • Bess LeRoy
  • Jane Lozano
  • Kiran Kundarapu
  • Mike Hamidi
  • Satheesh Avvaru
  • Vincent Guo
  • Vladlen Ivanushkin
  • Wendy Dobson

Meeting Discussion

Working Group Lead Minutes
Best Practices for Data Collection Instructions Todd Bazin and Aimee Basile Kick-off meeting occurred. Discussed frequency of meetings (Wendy sent a doodle). Going to keep original scope and concentrate on the treatment emergent white paper first. Possibly going to do a survey instead of interviews about AE process information and drill down.
CDISC Implementation Primer Beate Hientzsch, Yvonne Moore, Bess LeRoy Team is dropping one of the topics (CDISC compliance) due to bandwidth. At the CDISC Interchange in October the team will show a demo. Three minute videos with captivate content with an overview of each foundational standard. Traceability sub-team didn't receive any comments from public review but recently received comments from CDISC. Traceability is a powerpoint with a narrated script. Per Wendy, it will be put on the PhUSE site as a deliverable and can be linked to the CDISC site.
Data Reviewer's Guide in XML Mike Hamidi Team has made significant amount of progress since prototype loaded to PhUSE website. Did a presentation to the non-clinical team. Need to upload package to the PhUSE website for the FR notice (approximately September). Waiting on agreement from FDA with the plan.
Data Standards for Non-Interventional Studies Yuliia Bahatska and Vladlen Ivanushkin Continuing to work on draft of the white paper. Team will be discussing the rules that are applicable/not applicable to these studies.
Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Todd Case and Vincent Guo Presentation at PhUSE Single Day Event in September (Pennsylvania). Todd will attend. Draft white paper should be available for review by Jane/Lisa and steering committee in October.
Integrated SDTM and ADaM Reviewers Guide Kiran Kundarapu and Satheesh Avvaru Kick-off the week of 9 September. Wendy has sent a doodle to determine when most people can attend. Presenting at September Webinar. Jane to follow up with Matilde to discuss the project.
SDTM ADaM Implementation FAQ Bhavin Busa, Amy Palmer, and Aatiya Zaidi Ongoing project. Adjudication white paper - waiting for final deliverable from Umed and a summary of changes. Paper will go back to Jane/Lisa and then the steering committee to determine if another round of public review is necessary.

Wendy still wants to meet with the project co-leads to discuss process improvements. Unable to find a good time to meet due to summer holidays. ISS/ISE Best Practices white paper changing name (Integration Strategies in Support of ISS/ISE Submissions) and ready for steering committee in a couple of weeks.

  • Register now for EU Connect (November 9-12). Registration still open.
  • US Connect 2020 (March in Florida). Deadline to submit abstract is 13 September.
  • Wendy to have a 1:1 with Dave Epstein tomorrow. If you have anything that you would like Wendy to discuss with Dave please let her know.
  • The PhUSE site is being reorganized in regards to deliverables, including white papers. Timeline is early to mid-September. There will be a new gray bar at the top for Working Groups Deliverables which will be divided into three sections (Regulatory Referenced Deliverables, Deliverables Under Review, and White Papers).

Action Items

  • [Jane] Follow up with Matilde.