Data Standards Monthly Project Lead 16 December 2019 Meeting Minutes

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  • Project team updates


  • Aimee Basile
  • Jane Lozano
  • Janet Low
  • Lauren White
  • Satheesh Avvaru
  • Vincent Guo
  • Yuliia Bahatska

Meeting Discussion

Working Group Lead Minutes
Best Practices for Data Collection Instructions Todd Bazin and Aimee Basile Presenting Poster at the US 2020 Connect. Survey has been created and sent to PhUSE Community with a closing date of January 10th, 2020. Please complete the survey!
CDISC Implementation Primer Beate Hientzsch, Yvonne Moore, Bess LeRoy Presenting Poster at the US 2020 Connect. Interactive deliverables currently with CDISC to produce. Deliverable pushed out to Q22020.
Data Reviewer's Guide in XML Mike Hamidi Updated package published on PhUSE website. Gerry from the team presented at the Webinar on December 11th. Sub-team to work on the SDSP.
Data Standards for Non-Interventional Studies Yuliia Bahatska and Vladlen Ivanushkin Possible collaboration with Real World Evidence project (Emerging Trends & Technologies Working Group). Wendy will assist. White paper pushed out to Q22020. Presentation for FDA to assist with the white paper and team is waiting for answers.
Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Todd Case and Vincent Guo Team ensuring the two papers have a clear objective and the length is appropriate. Both white papers will be ready for review by Jane and Janet in January. Presenting Poster at the US 2020 Connect for the differences between FDA and PMDA.
Clinical Integrated Study Data and Analysis Data Reviewers Guide Kiran Kundarapu and Satheesh Avvaru Template is on Teamworks site for project members to edit and comment. First meeting in December was cancelled and will plan to meet on December 20. Lauren can send the agenda to get a better idea of who will actually attend.
SDTM ADaM Implementation FAQ Bhavin Busa, Amy Palmer, and Aatiya Zaidi Adjudication white paper is now published. ISS/ISE white paper should be ready this month to send back to Jane and Janet. Team continuing to get questions and publishing responses. Members of ADA project (non-clinical) for immunogenicity in SDTM and ADaM want to possibly collaborate with this team. Amy is the SME or someone within CDISC.

Action Items

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