Data Standards Monthly Project Lead 25 June 2018 Meeting Minutes

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2018-06-25

Agenda


  • Project team updates


Attendees

  • Jane Lozano
  • Lisa Brooks
  • Nate Friemark
  • Sandy VanPelt
  • Wendy Dobson
  • Yuliia Bahatska
  • Lex Jansen
  • Mike Hamidi

Meeting Discussion


Working Group Lead Minutes
Best Practices for Data Collection Instructions Todd Bazin No new update from last month. At Raleigh there is a possible co-lead for Todd. Wendy to confirm.
Best Practices for Metadata Documentation (Define-XML document versus reviewer's guide) Sandy VanPelt Nguyen Running behind between summer vacations and attending Connect. Looking at middle of July. Scope will be reduced in order to meet timeline (beyond original scope). Could submit new project request for additional scope.
CDISC Primer Scott Bahlavooni and Peter Van Reusel Defining scope and boundaries for four topics and have identified a lead for each of them. Scott has had to step back due to work related duties and Peter has been working on CDISC training. Looking into interactive tools for this project. Jasmine Kestermont (Peter's wife) has been involved with the project. Final deliverable would be interactive visual tools. Will present at July webinar and to recruit people to start building the tools.
Clinical Legacy Data Conversion Plan & Report Jane Lozano cSDRG template for LCDP and alignment with TCG along with completion guidelines. Next step is to update the example documents with the LDCP and the current example documents. The ADRG example document needs an ADRG expert to apply ADaM rules and align the LDCP section with the main section. A lot of comments, but no one to update it based on the comments. John Brega gave Jane a name that may be helpful with this task. Jane to send email and if not successful Wendy can assist with communications to recruit a volunteer. Sandy's white paper will have suggestions for the cSDRG.
Data Standards for Observational Studies Yuliia Bahatska and Vladlen Ivanushkin Going to present at July webinar.
Data Reviewer's Guide in XML Mike Hamidi Finished a majority of the technical aspects of the project. Currently fine-tuning the remaining schema tasks. Also working on draft reference document. Team should have deliverables in July for Lisa and Jane to review.
Define-XML v2.0 Completion Guidelines Marcellina Hungary and Prafulla Girase Last week of July for deliverables.
Define-XML v2.0 Stylesheet Recomendation) Dmitry Kolosov and Lex Jansen Lisa's comments (and those from the person that she asked) reviewed by the team. Next team meeting is 3 July. Team needs to tighten loose ends before sending to steering committee. Deliverables will be available for review in July and steering committee agenda on 10 August. The PhUSE process will ensure that all groups can review. The project team can send to other groups with the link to the deliverables on the PhUSE site.
Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Todd Case and Vincent Guo Todd, Wendy, and Vincent met last week. Meeting again on 26 June and then will assign people to work on the white paper. May change name of project - discussion forum live on the Wiki page. Kiran and Bhavin attend these meetings to ensure there is no overlap.
Pooling WHO Drug B3 Format (Best Practices for Integrated Databases) Marlo Searcy and Joyce Leflar Marlo updated the white paper and it has been published on the PhUSE site. Marlo will present at next quarterly FDA meeting in September. Project is now concluded and Wendy will archive the project on the Wiki.
SDTM ADaM Implementation FAQ Bhavin Bhusa, Peter Van Reusel, and Kiran Kundarapu Ongoing project. Team attended internal quarterly FDA meeting. Team working on ISS/ISE white paper project. Created adjudication team. Need FDA support and team putting together more documentation to request their support.


US CSS for 2019 will be in June in Silver Spring. US Connect will be in February 2019 in Baltimore. Registration opens 2 July.


Action Items

  • [Lisa] Follow-up with the people that she asked to look at the Define-XML 2.0 Stylesheet.
  • [Wendy] Follow-up with Marlo and Joyce regarding the review of their white paper prior to publishing as a final deliverable.