Data Standards Monthly Project Lead 27 May 2020 Meeting Minutes

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2020-05-27

Agenda


  • Project team updates


Attendees

  • Jane Lozano
  • Janet Low
  • Kiran Kundarap
  • Lauren White
  • Satheesh Avvaru

Meeting Discussion


Working Group Lead Minutes
Best Practices for Data Collection Instructions Mary Nilsson and Aimee Basile No new updates.
CDISC Implementation Primer Beate Hientzsch, Yvonne Moore, Bess LeRoy No new updates.
Data Reviewer's Guide in XML Mike Hamidi No new updates.
Data Standards for Non-Interventional Studies Yuliia Bahatska and Vladlen Ivanushkin Finalizing the hands-on experiences section of the white paper. By the next meeting on June 8, the white paper should be ready for Jane and Janet's review. Abstract for EU Connect in November has been accepted.
Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Todd Case and Vincent Guo Vincent recently changed companies. Need to ensure PHUSE has his new email address at J&J. Reviewed comments from Japan members on this project. Industry Experiences white paper will be ready for review by Jane and Janet soon. Differences between FDA and PMDA white paper being updated. Plan is to get the Industry Experiences white paper out first. There is interest from the Japan team to continue with the project, but a new project request should be submitted.
Clinical Integrated Study Data and Analysis Data Reviewers Guide Kiran Kundarapu and Satheesh Avvaru Two templates will be created, icSDRG and iADRG. Will split the time in the team meetings. Forming the icSDTM team as more people on the team are familiar with integrating ADaM. Timelines will need to be revised based on the two templates.
SDTM ADaM Implementation FAQ Bhavin Busa, Amy Palmer, and Aatiya Zaidi ISS/ISE white paper sent to steering committee to get approval for public review. Bhavin will start on a new project request which will close out the current project and describe the vision for the future state. Going to address pending questions. New project idea being drafted. More of a webinar type of project. Industry experts come in and address specific questions on a monthly basis. ISS/ISE white paper is out for public review with a due date of June 15. Presenting at CDISC webinar on June 30.


  • US CSS has been postponed until September 21-23 (Monday - Wednesday). Any questions related to the CSS in regards to travel should be addressed to events@phuse.eu.
  • CSS registration and call for papers open June 1.


Action Items

  • [Jane] Complete template to request FDA participation in the DRG in XML and Clinical Integrated Study Data and Analysis Reviewers Guide projects.
  • [Jane and Janet] Determine schedule for break out sessions for the virtual CSS in September.