Data Standards Monthly Project Lead 27 November 2017 Meeting Minutes

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  • Updates from project leads
  • US CSS 2018


  • Marcelina Hungria
  • Jane Lozano
  • Lisa Brooks
  • Prafulla Girase
  • Sandy VanPelt
  • Wendy Dobson

Meeting Discussion

Working Group Lead Minutes
Best Practices for Data Collection Instructions Todd Todd presented at CDISC Interchange and he is going to meet with Mary (SACS Working Group) to start drafting the white paper.
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. The deliverable should go to Jane and Lisa first. Meeting tomorrow (28 November) to discuss content based on CDISC Interchange interactions.
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 Interchange 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. Still trying to have the draft out for internal review (project team) 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 Lex is currently working on the last updates to the stylesheet. Team is planning to get feedback using e-mail, PhUSE Wiki page, and a survey. Dmitry has found something which meets the team's needs and will also ask if CDISC can host it. One of the team members noticed that Nonclinical Topics working group had organized a survey lately. The deliverable has to go to Jane and Lisa first. Then it will be shared with the CSS Steering Committee. The survey could also be shared with the steering committee. Wendy can create a survey using Survey Monkey. Then the survey can go live and go on the Wiki with mail shots.
GDPR Impact on Collection Practices Sara Pauwels Meeting tomorrow with CDISC. Wendy has put a call out for volunteers. Sara will be presenting at the Webinar on Wednesday (29 November).
Pooling WHO Drug B3 Format (Best Practices for Integrated Databases) Joyce and Marlo Team is meeting once a month and just getting started.
SDTM ADaM Implementation FAQ Mat and Bhavin More questions are ready to be published to the Wiki page. Wendy to work with Bhavin on ways to submit questions and making some improvements for efficiency. For example, how to let the person who asked the question that a response was posted. The link to ask a question was moved to be above the link to the published responses.
Standardizing Data within the Inspection Site Selection Process Parag No new update.
Study Data Standardization Plan (SDSP) Jane Steering Review meeting this week on the deliverables. Plan is to have it published by year-end.

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. Those that have not responded, 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 in January 2018 at the usual time.

The version control process to be used for all PhUSE deliverables has been updated and was shared during this meeting. However, it is not yet finalized. The plan is to get that done soon and make public by year-end. Please note that for process boxes 21-23, it was suggested that the words 'Project Working Group' be replaced with 'Project team'. Wendy will discuss with Chris (Hurley) this week.

Action Items

  • [Sandy] Send suggested updates to the cSDRG and ADRG to Jane and Lisa.
  • [Wendy] Schedule meetings for 2018. They will be at this time and on the last Monday of the month.