Data Standards Monthly Project Lead 23 March 2020 Meeting Minute

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  • Project team updates


  • Bhavin Busa
  • Jane Lozano
  • Janet Low
  • Kiran Kundarap
  • Satheesh Avvaru
  • Vincent Guo
  • Wendy Dobson

Meeting Discussion

Working Group Lead Minutes
Best Practices for Data Collection Instructions Todd Bazin and Aimee Basile No new updates.
CDISC Implementation Primer Beate Hientzsch, Yvonne Moore, Bess LeRoy Presentation for US Connect will be available on the PHUSE site in the near future. Animation piece with CDISC.
Data Reviewer's Guide in XML Mike Hamidi No new updates.
Data Standards for Non-Interventional Studies Yuliia Bahatska and Vladlen Ivanushkin Yuliia to be in a call with David Epstein (FDA) today to assist in answering questions from presentation to FDA last year. in contact with Amgen programmers to gather more real-life experience of corresponding section
Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Todd Case and Vincent Guo Jane reviewed the Industry Experiences white paper and sent back to Vincent and Janet. Jane and Janet has reviewed the FDA/PMDA differences white paper. Created a presentation for US Connect. Can do a Steering Committee review and public review at the same time (Janet and Jane to discuss further after white papers have been sent back for our review).
Clinical Integrated Study Data and Analysis Data Reviewers Guide Kiran Kundarapu and Satheesh Avvaru Continuing with creating one template but need to determine if there should be one or two templates. Plan to decide at the next meeting (March 27). Sent the justification for a session at the CSS to Janet, Wendy, and Jane but will revisit due to the postponement of CSS.
SDTM ADaM Implementation FAQ Bhavin Busa, Amy Palmer, and Aatiya Zaidi ISS/ISE white paper continuing to be updated. Bhavin will provide an update after contacting Aatiya. The FAQ Team meet every two weeks and have a good number of people attending. The number of questions have been reduced. Steering Committee would like to have a better definition of the project in order to keep it going. The process is working well. Janet and Jane to have a further discussion with Chris Price. Bhavin suggests to open this to the public and be a part of the FAQ Team meeting (Ask the Expert type of forum). Disclaimer is important to communicate. If scope is going to change, the current project request would be completed and a new one is created. Wendy will confirm. Bhavin will start on a new project request after confirmation from Chris.

  • 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
  • Lauren is going to support a process to update deliverables on a regular basis. More information to follow.

Action Items

  • [xxxx] .