Data Standards Monthly Project Lead 23 March 2020 Meeting Minute

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  • Project team updates


  • Bess LeRoy
  • Bhavin Busa
  • Jane Lozano
  • Janet Low
  • Mike Hamidi
  • Satheesh Avvaru
  • Vincent Guo
  • Wendy Dobson
  • Yuliia Bahatska

Meeting Discussion

Working Group Lead Minutes
Best Practices for Data Collection Instructions Todd Bazin and Aimee Basile Team is finalizing poster for US 2020 Connect. They received 40 plus responses from the survey. No new updates.
CDISC Implementation Primer Beate Hientzsch, Yvonne Moore, Bess LeRoy Team regrouped in January. Compliance piece still stalled. Plan to finish by CSS in June. No session needed, but Traceability is interested in doing a presentation. Presenting at the US 2020 Connect. Bess sent a presentation to Wendy about the project. Still need to figure out to show the Primer on the CDISC and PHUSE sites. Jane and Janet to be included in the conversations. 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 changes on the project. A team member reached out on the nonclinical SDRG and will do a gap analysis on the nSDRG and cSDRG. Not sure about the CSS. Mike is attending US Connect.
Data Standards for Non-Interventional Studies Yuliia Bahatska and Vladlen Ivanushkin Added two new sections in the white paper. Awaiting feedback from the FDA (no new updates). Plan on creating a poster for the EU Connect. Most of the team members are in the EU so will not need a session at the CSS. White paper is not dependent on the FDA feedback. Yuliia to be in a call with David Epstein (FDA) today to assist in answering questions from presentation to FDA last year.
Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Todd Case and Vincent Guo The white paper on the the differences between FDA and PMDA has been sent to Jane and Janet. The other one is in progress as the team is preparing for the US 2020 Connect. Should send to Jane and Janet within the next couple of weeks. Vincent would like to have a session at the CSS. 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.
Clinical Integrated Study Data and Analysis Data Reviewers Guide Kiran Kundarapu and Satheesh Avvaru Looking for others to assist with the Completion Guidelines and example documents. Team discussed the possibility of having two separate templates and will make a decision next month. Janet has recruited a couple of people to participate on this project. Kiran and Satheesh to discuss if they would like to have a session at the CSS. March 13 meeting is still on even though this is after US Connect. 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 is currently being updated. New version by end of next week. There is a case study on the creation of the integrated SDTM and has referenced a PHUSE poster from last year. No new update on ADA project. Team continuing to get questions and publishing responses. Bhavin would like to have a session at the CSS in June. 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] .