Data Standards Monthly Project Lead 30 October 2017 Meeting Minutes

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  • Updates from project leads
  • US CSS 2018


  • Dmitry Kolosov
  • Jane Lozano
  • Joyce Leflar
  • Lex Jansen
  • Marlo Searcy
  • Mike Hamidi
  • Sandy VanPelt
  • Wendy Dobson

Meeting Discussion

Working Group Lead Minutes
Best Practices for Data Collection Instructions Todd The team is continuing to work on Disposition (end of treatment, end of study). Todd is going to attend the CDISC Intrachange in November and there will be a session on this project. The team hasn't met since the 15-September due to availability. Todd is working with Scott on the content. Next meeting scheduled for 3 November.
Best Practices for Metadata Documentation (Define-XML document versus reviewer's guide) Sandy Team continuing on white paper which will focus on Define-XML and reviewer's guide. The goal is to have it ready for CSS Steering Committee review by the end of the year. Sandy will work with Marcelina on any overlaps. All initial content is drafted - working on organization. There are suggestions for the cSDRG and ADRG. Sandy will send them to Jane.
Clinical Legacy Data Conversion Plan & Report Jane The team is finalizing work on the first example document (legacy data conversion to SDTM only). There is enough content to begin working on the completion guidelines. Team is now working on the second example document (legacy conversion from SDTM IG 3.1.1 to a version currently supported per the Data Standards Catalog).
Data Reviewer's Guide in XML Mike Team is reviewing the third prototype (cSDRG) which includes a mock render of the PDF, the xml element, and supporting stylesheet. Mike is going to attend the CDISC Intrachange in November and there will be a session on this project. There is going to be a deep dive on Todd's project and the FAQ project of which Mike will lead. Mike is working with Scott on the content. There may be a fourth version of the cSDRG and provide a test sample to FDA to check internally with their systems for compatibility. FDA has been participating informally.
Define-XML v2.0 Completion Guidelines & Stylesheet Recommendations - Define-XML v2.0 Completion Guidelines Marcellina and Prafulla There are two new members to the group. Team continues the work on priority topics selected for the draft completion guidelines. Estimate to have the draft out for internal review by the end of the year. The outcome of the new "Nonclinical Topics / Demystifying Define-XML Codelist Handling for Nonclinical Studies" project will be coordinated with the Define-XML Completion Guidelines as well.
Define-XML v2.0 Completion Guidelines & Stylesheet Recommendations - Define-XML v2.0 Stylesheet Recomendation) Dmitry and Lex Request from various CDISC/PhUSE teams to integrate vlm with the dataset view. This is a big change and the team is amending the Stylesheet. It should be done in November and available for the CSS Steering Committee by the end of the year.
GDPR Impact on Collection Practices Sara Pauwels New project. Need another co-lead. Wendy has added a Wiki page and put on the call for volunteers in the monthly mailing to go out this week. Sara will present at the webinar on 15 November. Co-lead should be someone from CDISC. Scott and Jane to coordinate. New project request updated with new project name.
Pooling WHO Drug B3 Format (Best Practices for Integrated Databases) Joyce and Marlo A new team member joined. The team is meeting once a month for the remainder of the year with the intention of having a draft white paper for review prior to the CSS in March 2018. Looking at options for collaborating so that multiple people can review/edit the same document.
SDTM ADaM Implementation FAQ Mat and Bhavin There was a discussion club session at the PhUSE Annual Conference in October. Due to the low turnout of the discussion club, there were no break out sessions. By the time it got to this project, the group was short on time. Questions continue to come in to the team. Part of the feedback from the discussion club is that whether the team has a response or not, the question should be posted to avoid the same question asked multiple times. Team is actively meeting every 2 weeks.
Standardizing Data within the Inspection Site Selection Process Parag No new update.
Study Data Standardization Plan (SDSP) Jane Deliverables were updated per FDA comments. CBER has made additional changes based on questions when updating the completion guidelines. Jane to update template and example documents. Jane sent everything but the completion guidelines to Crystal and will send again after updates are made.

US CSS has been scheduled for March 4-6 in Silver Spring. Registration opens November 1st along with the call for abstract for the poster session. Closing date is 12 January 2018. Jane, Lisa, and Wendy will be working on the schedule for the break out sessions. Please let us know if you will be attending. Details needed by the end of January, preferably sooner. Wendy will be working on the brochure and reaching out to the project leads.

Next meeting is 27 November at the usual time.

Action Items

  • [Jane L] Work with Scott Bahlavooni to get CDISC representation on the new project (GDPR Impact on Collection Practices).
  • [Sandy] Send suggested updates to the cSDRG and ADRG to Jane L.
  • [Wendy] Send the updated project deliverable process flow to the project team leads.
  • [Wendy] Ask Jane Seery if information about the upcoming webinar in November is going to Jane Lozano at the correct email address.