Data Standards Monthly Project Lead 26 February 2018 Meeting Minutes

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  • Review US CSS 2018 Sunday Open Session slides


  • Dmitry Kolosov
  • Jane Lozano
  • Joyce Leflar
  • Lex Jansen
  • Lisa Brooks
  • Marcelina Hungary
  • Peter Van Reusel
  • Sandy VanPelt
  • Todd Case
  • Wendy Dobson

Meeting Discussion

Working Group Lead Minutes
Best Practices for Data Collection Instructions Todd Team has finished disposition and is now working on adverse events. Todd will not be attending CSS but provided an update to the slide. Todd will not be attending CSS this year.
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. There are comments in regards to the cSDRG template with the headers and footers. Sandy will not be attending CSS this year.
CDISC Primer Scott Bahlavooni and Peter Van Reusel CDISC is considering developing a scaled down version of their existing standards to support academic research and secondary use of clinical research datasets. The new project, in collaboration with CDISC, will identify needs of new CDISC implementers with a focus on academia and technology providers. Scott will be leading a session at CSS this year.
Clinical Legacy Data Conversion Plan & Report Jane There are two example documents on the Wiki for the team to review. The template for the cSDRG and ADRG have been updated and are on the Wiki. Identified someone to work on the cSDRG Completion Guidelines. There is going to be a workshop at the CSS on Monday night to discuss the maintenance of the clinical and nonclinical SDRGs. Jane will be leading a session at CSS this year.
Data Reviewer's Guide in XML Mike Team should have deliverables in March/April for steering committee review. Mike will not be attending CSS this year.
Define-XML v2.0 Completion Guidelines & Stylesheet Recommendations - Define-XML v2.0 Completion Guidelines Marcellina and Prafulla The team has a draft of the Completion Guidelines with the expectation to have team comments back by CSS. Marcellina will be attending CSS this year.
Define-XML v2.0 Completion Guidelines & Stylesheet Recommendations - Define-XML v2.0 Stylesheet Recomendation) Dmitry and Lex Team plans on having a stylesheet ready for steering committee review in Q2. Dmitry and Lex will not be attending CSS this year.
GDPR Impact on Collection Practices Sara Pauwels This project is currently on hold due to Sara taking a medical leave of absence.
Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Todd Case This new project provides a collaborative, non-competitive forum for industry to share submission experiences including, but not limited to submission planning, interactions with the regulators, test submissions, regulator feedback etc. Scott Bhalavooni will be leading a session at CSS as Todd will not be able to attend.
Pooling WHO Drug B3 Format (Best Practices for Integrated Databases) Joyce and Marlo Team continues to work on an initial draft of the white paper. Joyce and Marlo will not be attending CSS this year.
SDTM ADaM Implementation FAQ Bhavin Team would like to make the process of asking and answering questions slicker. There will be another promotional push on social media and via mailshots. The team would like to include PMDA. Patty Brundage (FDA) will reach out to a PMDA contact. Bhavin will be attending CSS this year. Bhavin is also looking for a co-lead as Matt is unable to continue to work on this project. Thank you Mat for your contributions!
Study Data Standardization Plan (SDSP) Jane The deliverables have been published. There is no need for a session at CSS.

US CSS has been scheduled for March 4-6 in Silver Spring. The sessions for this working group are on the Wiki.

The version control process to be used for all PhUSE deliverables has been finalized. It is located on the Wiki under Projects "CSS Working Groups".

Action Items

  • [Jane] Send email to Bhavin about his slide for the opening session.
  • [Wendy] Send names of PMDA people coming to CSS to Lisa and Jane.