Data Standards Monthly Project Lead 27 April 2020 Meeting Minutes

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2020-04-27

Agenda


  • Project team updates


Attendees

  • Jane Lozano
  • Janet Low
  • Kiran Kundarap
  • Satheesh Avvaru
  • Wendy Dobson

Meeting Discussion


Working Group Lead Minutes
Best Practices for Data Collection Instructions Mary Nilsson and Aimee Basile Presenting at Webinar on April 29 the results of the survey. Using abstract from US Connect to create the white paper. Need to determine if the white paper will include recommendations versus survey results. In September the project will be transferred back to Mary with the hope of a white paper published before then if it makes sense.
CDISC Implementation Primer Beate Hientzsch, Yvonne Moore, Bess LeRoy Animation piece still with CDISC. With the COVID activities related to CDISC, this is a lower priority.
Data Reviewer's Guide in XML Mike Hamidi The second cSDRG in XML prototype package was released on 26-Nov-2019, which allows sponsors and technology vendors to evaluate and test. This version was also intended to support the FDA pilot. However, the FDA has requested to pilot the nSDRG instead of the cSDRG. Development of an nSDRG in XML version has been temporarily suspended due to lack of technical volunteers and interest. This also impacts potential future initiatives targeting the ADRG and SDSP in XML.
Data Standards for Non-Interventional Studies Yuliia Bahatska and Vladlen Ivanushkin Yuliia in contact with Amgen programmers to gather more real-life experience of corresponding section. Yuliia met with Dave (FDA) and is waiting for responses. Still on target for Q2 white paper publication.
Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Todd Case and Vincent Guo Team is reviewing the comments on the two white papers, including feedback from Japan CDISC SDTM and ADaM teams. Next step is to send back to Janet and Jane prior to public review.
Clinical Integrated Study Data and Analysis Data Reviewers Guide Kiran Kundarapu and Satheesh Avvaru Team decided to create one template for SDTM (icSDRG) and one template for ADaM (iADRG). Looking for two volunteers to work on the icSDRG efforts. Meeting on May 8th cancelled due to bank holiday in the EU.
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.


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


Action Items

  • [xxxx] .