Data Standards Monthly Project Lead 26 June 2017 Meeting Minutes

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  • Updates from project leads
  • EU CSS


  • Jane Lozano
  • Marcelina Hungary
  • Mat Bryant
  • Mike Hamidi
  • Susan Kenny
  • Todd Bazin
  • Wendy Dobson

Meeting Discussion

Working Group Lead Minutes
Best Practices for Data Collection Instructions Todd The team has met 3 times. The first domain the team is working on is Disposition. They are finding that there is a lot of variability in what is collected and how it is collected. The team plans on creating a use case with suggested best practices along with pros and cons. The team understands that a trial's design will impact the use case.
Best Practices for Metadata Documentation (Define-XML document versus reviewer's guide) Sandy No new update.
Data Reviewer's Guide in XML Mike There has been another round of reviews for the second prototype for the cSDRG. The team has received feedback from FDA. Crystal Allard is actively involved. The team is also building a stylesheet with the XML. There are several projects involving XML. This project is building the framework in which deliverables are in a single document. The next meeting is the 2nd week of July in which the team will have the third round of review.

The team is anticipating a review by the CSS Steering Committee in July or August. The team understands that the PDF version of the reviewer's guides are not going away as some reviewers prefer the PDF version.

Define-XML v2.0 Completion Guidelines & Stylesheet Recommendations - Define-XML v2.0 Completion Guidelines Marcellina The team is meeting every other week and working on the timeline for the delivery of the completion guidelines for review. Her team is working closely with Dmitry and Lex.
Define-XML v2.0 Completion Guidelines & Stylesheet Recommendations - Define-XML v2.0 Stylesheet Recomendation) Dmitry and Lex Dmitry and Lex sent an email with updates. The team is planning to have an internal review of the Stylesheet before the public review. For the review, there will be 2 versions of the rendered Define-XML, so that people can see what can be shown/how it can be shown. One version will have more attributes than the other one. The reviewers will provide their feedback on whether they want to see it in the default rendered version or not. Dmitry and Lex are finishing the preparation for the internal review. it will be available in Q3.
Legacy Data Conversion Plan & Report Jane The sub-group working on the example documents has created one for a conversion from legacy tabulation data to SDTM. The Completion Guidelines sub-group can now begin using the example document. The template has also changed based on example document and the information that is in the document. There were redundant sections and those were removed.
SDTM ADaM Implementation FAQ Mat and Bhavin Chris Price facilitated sessions at the EU CSS. Wendy is going to document the information on the flip charts. There is a webinar on Wednesday this week on the EU CSS. There is a co-lead meeting tomorrow and Mat will be able to provide more of an update after that meeting. Mat and Bhavin are considering combining the sub-group meetings into one with the exception of the Data Submissions sub-group. A new Wiki page will be created to publish approved questions/answers. The team continues to work on a technology solution to ask a question as not everyone can access Google docs.
Standardizing Data within the Inspection Site Selection Process Parag No new update.
Study Data Standardization Plan (SDSP) Jane CBER Appendix has been created along with Completion Guidelines. Jane has sent the deliverables to CBER for review. Nonclinical has provided their feedback and Jane will incorporate. She will send all deliverables to her project team for review.
WHO Drug B3 Format Best Practices for Integrated Databases Joyce and Marlo Jane is meeting with Joyce and Marlo this week to show them how to use the Wiki to put information about the project and how to create meeting minutes. Wendy encourages all teams to use Teamworks.

Action Items

  • [Jane] Communicate with Barrie regarding the last project as CDISC may be doing something in this area.