Data Standards Monthly Project Lead 23 September 2019 Meeting Minutes

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  • Project team updates


  • Aatiya Zaidi
  • Amy Palmer
  • Bess LeRoy
  • Bhavin Busa
  • Jane Lozano
  • Kiran Kundarapu
  • Mike Hamidi
  • Satheesh Avvaru
  • Todd Case
  • Wendy Dobson
  • Yuliia Bahatska

Meeting Discussion

Working Group Lead Minutes
Best Practices for Data Collection Instructions Todd Bazin and Aimee Basile At their Sept 13 meeting, it was decided to submit an abstract for a poster presentation on the results of a survey they are designing that will collect information about the methods of adverse event collection across the industry. It will be a web-based survey and will be sent out to as many sponsors as possible by using LinkedIn connections, CRO partners and cross-industry membership organizations (SCDM, PHUSE, etc.). The survey will consist of questions around both the collection of adverse events and the analysis of treatment emergent adverse events. The survey will be sent out in late October/early November with responses back in December.
CDISC Implementation Primer Beate Hientzsch, Yvonne Moore, Bess LeRoy Working to (CDISC side) to put the linking of models in a wireframe demo based on captivate by the CDISC Interchange in October. Traceability presenting at SDE in September with the goal of creating educational videos. Primer Abstract for PhUSE US Connect meeting next year. Not sure if Traceability going to create an abstract, but will be discussed in the Primer abstract.
Data Reviewer's Guide in XML Mike Hamidi Updated stylesheet, expanded type of content to manage, updated schema to account for the changes. FDA focused on non-clinical, but want to make sure this package for clinical can be adapted for non-clinical use. Plan to provide updated version for industry to begin utilizing. Pinnacle 21 and other vendors interested. Updated package to be loaded to PhUSE deliverables page. Focus will shift to non-clinical DRG. Vendors can build a more machine driven process even if the final deliverable is pdf.
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. Pinnacle 21 representative and CDISC are part of the project team. Webinar on September 25 will discuss this project.
Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Todd Case and Vincent Guo Presentation at PhUSE Single Day Event in September 26 in Pennsylvania. Todd will attend and present an overview of the white paper. Draft white paper should be available for review by Jane/Janet and steering committee in October.
Integrated SDTM and ADaM Reviewers Guide Kiran Kundarapu and Satheesh Avvaru Kick-off meeting on September 12. Webinar on September 25 will discuss this project. Survey questions were created and will be submitted to the members by Wendy after confirmation from Kiran and Satheesh. Next meeting in October. Team will have 10 minutes in the Webinar.
SDTM ADaM Implementation FAQ Bhavin Busa, Amy Palmer, and Aatiya Zaidi Ongoing project. Adjudication white paper - Updates made and Jane reviewed. Back to Steering Committee for review. ISS/ISE Integration Strategies in Support of ISS/ISE Submissions white paper was reviewed by Jane and Lisa. Comments have been shared with the team. Immunogenicity meeting last week - still under discussion.

Key attendee is currently out of the office due to illness. Next meeting estimated to be in October. Nonclinical reached out to this project team on how to represent immunogenicity parameters when ADaM doesn't exist. Not sure as to what the deliverable will be at this time. Team has received new questions that the team is addressing. Questions received in the past that were not addressed are incorporated into an excel spreadsheet in Teamworks. Process improvements being done.

  • Register now for EU Connect (November 9-12). Registration still open.
  • There are two templates on the PHUSE site that should be used (generic and working group). Webinars should use the working group template. When presenting at a SDE or conference use the generic template.

Action Items

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