Data Standards Monthly Project Lead 30 July 2018 Meeting Minutes

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  • Project team updates


  • 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 Team has finished disposition and is now working on adverse events. Todd is looking through a LONG list of AE related questions and looking to define clear data entry recommendations. Todd still looking for a co-lead. (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 Team continuing on white paper. Finishing up on examples and combining content into one paper. Included is what type of metadata and where it should be documented (Define-XML or reviewer's guide) with the objective to eliminate redundancy. There is a section on how to handle outliers along with differences between review agencies. White paper will be available for Steering Committee review in the last half of June./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 Team starting with visualizations. Final deliverable not yet defined. Team still recruiting members. (No new update from last month)/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 and completion guidelines updated for the LDCP and to be in alignment with the TCG. These are to be finalized at the next meeting. All example documents will be updated after the template is finalized. The deliverables may be sent to the steering committee separately as the cSDRG is farther along than the ADRG. The ADRG template has been updated to include the LDCP and to be in alignment with the TCG. Jane contacted the original authors of the ADRG to ask if they would like to be included in this update. Jane also let Crystal (FDA) know why a FDA representative would be needed for input similar to what was done with the cSDRG./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 New project. Wendy indicated that there is a new project member. Jane sent project start-up slides to Yuliia and Vladlen to assist with updating the Wiki page for this project./Going to present at July webinar.
Data Reviewer's Guide in XML Mike Hamidi Project team is focusing on finalizing the remainder of the XML/Schema content for the DRG in XML. Technical findings with Schema and Stylesheet. Team should have deliverables in June for steering committee review. (No new update from last month)/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 & Stylesheet Recommendations - Define-XML v2.0 Completion Guidelines Marcellina Hungary and Prafulla Girase Timeline updated to provide deliverable to Jane and Lisa in August. Team members include representatives from CDISC Development Team. However, a broader CDISC review will occur after the Steering Committee has reviewed the document. (No new update from last month)/Last week of July for deliverables.
Define-XML v2.0 Completion Guidelines & Stylesheet Recommendations - Define-XML v2.0 Stylesheet Recomendation) Dmitry Kolosov and Lex Jansen Lisa provided comments to Dmitry and Lex. She also asked a few people to look at the stylesheet. After the updates are made, the deliverables will be shared with the steering committee./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 Jane followed up with Todd and Vincent regarding meeting minutes. They are also in Teamworks. However, not everyone has access to Teamworks./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) Joyce Leflar and Marlo Searcy White paper review period has ended. Wendy will follow up with Marlo and Joyce to see if they received any comments./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.