Data Standards Monthly Project Lead 24 April 2017 Meeting Minutes

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  • Updates from project leads in preparation for the Webinar on April 26th
  • Discuss projects that need a CSS Steering Committee review


  • Dmitry Kolosov
  • Jane Lozano
  • Jean Mulinde
  • Lex Jensen
  • Marcelina Hungria
  • Sandy VanPelt Nguyen
  • Todd Bazin
  • Wendy Dobson

Meeting Discussion

  • For the upcoming webinar on April 26th updates from each project team were discussed with the exception of the SDTM ADaM Implementation FAQ project. Jane met with that group the hour prior to this meeting. Minutes from that meeting are included below.
Working Group Lead Minutes
Best Practices for Metadata Collection Instructions Todd Todd has been out of the office and will provide Jane a slide today. There was great participation at the CSS and there is a CDISC representative that was involved (Shannon Labout) and will continue to work with this project team.
Best Practices for Metadata Documentation (Define-XML document versus reviewer's guide) Sandy The team is continuing to work on the white paper and will share the information to ensure there is no overlap with the other Define-XML projects. Also, the verbiage 'define.xml' was changed to 'Define-XML document' to be consistent with the other projects. Sandy approved the slide for the Webinar.
Data Reviewer's Guide in XML Mike Mike was not able to attend and sent Jane his update for the Webinar.
Define-XML v2.0 Completion Guidelines & Stylesheet Recommendations - Define-XML v2.0 Completion Guidelines Marcellina The word 'Implementation' was replaced with 'Completion Guidelines' in the name of the project. Wendy has updated Teamworks and will work with Wiki IT to change it on the Wiki. Also, the format of 'Define' in the original project name has been replaced with 'Define-XML'. Marcellina will send an updated slide for the Webinar on Tuesday.
Define-XML v2.0 Completion Guidelines & Stylesheet Recommendations - Define-XML v2.0 Stylesheet Recomendation) Dmitry and Lex There were 3 questions that Dmitry sent to Jane regarding the need for FDA input: 1) 1. Defining the technical requirements that the FDA has for a standard Define-XML v2.0 stylesheet (Lex and Dmitry have been in contact with FDA and the eSub team provided them with required technical details and they are waiting for a response from the eData team.) 2) Validating the idea whether FDA wants to reference or require a standard Define-XML v2.0 stylesheet. FDA does not like receiving inconsistent stylesheets from sponsors. Dmitry/Lex will ask the eData team as this affects the Data Standards Catalog. 3) Reviewing the HTML rendition of the standard Define-XML v2.0 stylesheet. Jane suggested that when there is something to review, Wendy will put this as an agenda item for the CSS Steering Committee to review. The next meeting is May 5th, but this may be too soon. The steering committee meets every 2 weeks. Dmitry/Lex will discuss in their team meeting tomorrow. Jane has the updated slide for the Webinar.
Legacy Data Conversion Plan & Report Jane The slide is ready for the Webinar. The current cSDRG and ADRG will be updated with a new section for this information.
SDTM ADaM Implementation FAQ Mat and Bhavin Team continuing to work on the structure and the best way to technologically set it up. The form on the project Wiki site is a Google form that goes to Bhavin's personal email. This needs to be changed for long term use. There are about 20-25 questions and responses that could be published. There needs to be a way to publish them, which is also part of the technology. Bhavin will provide Jane and Wendy with the location on the Teamworks site of these 20-25 questions and responses which will be an agenda item on the next CSS Steering Committee agenda. The steering committee needs to be able to review prior to the meeting on May 5th. FDA is part of the steering committee. Jane created the slide for the webinar based on their wrap-up slides presented at the CSS in March (located on their project Wiki site). The sub-teams are making progress, while there are 2 sub-teams in need of a lead.
Standardizing Data within the Inspection Site Selection Process Parag Jean attended a session at the CDISC Intrachange after the CSS in March.

Diane Wold included this in a session she facilitated on non-subject level data. Jane to follow-up with Nate Freimark to get an update. There may or may not be a slide for the Webinar. Per email from Nate on 4/24/17: We still have to regroup on the ADaM side. Due to my recent time commitments it has not happened yet but hopefully will in the in next few weeks.

Study Data Standardization Plan (SDSP) Jane The slide is ready for the webinar. There will be one template for CDER and CBER with the addition of an appendix that is CBER specific. It could be used within CDER, but is needed by CBER. The appendix will be put on the Wiki.
  • There is a project on the PhUSE EU site looking for volunteers and a project lead for a project that came from the Standard Analysis and Code Sharing Working Group. The project name is 'Implementing the WHO Drug B3 Format Best Practices for Integrated Databases'. Once a project lead (or co-leads) are identified, a new project request will be completed for the steering committee to review and approve the project.
  • There are other potential projects identified at the CSS from the round table discussion. Jane and Susan have reviewed and sent responses to all in the Optimizing the Use of Data Standards Listbox group. Jane will work with Wendy to add the ones that could be done to the same place as the WHO Drug project.
  • The SDTM ADaM Implementation FAQ project will have sessions at the EU CSS in June (in London). Scott will work with Bhavin/Mat/Wendy on the agenda and determine how many people are needed to lead the sessions. The initial thought is to have an initial open forum on the current questions/responses as well as have questions for each sub-group to work on. Scott would like to have them by May 19th. Chris Price will be attending the EU CSS and is available to facilitate.

Action Items

  • [Jane] Follow up with Nate regarding the inspection site selection process project.
  • [Dmitry/Lex] Send question about having a standard Define-XML v2.0 stylesheet to the eData team.
  • [Dmitry/Lex] Let Jane and Wendy know when they are ready for the steering committee to review the HTML rendition of the stylesheet.
  • [Wendy] Work with Wiki IT support to change the name of the Define-XML v2.0 Completion Guidelines and Stylesheet project.
  • [Jane] Send Wendy information about other potential new projects for this working group.