Data Standards Monthly Project Lead 29 January 2018 Meeting Minutes

From PHUSE Wiki
Jump to: navigation, search



  • Updates from project leads
  • US CSS 2018


  • Dmitry Kolosov
  • Marcelina Hungria
  • Jane Lozano
  • Jean Mulinde
  • Lisa Brooks
  • Sandy VanPelt
  • Todd Bazin
  • Todd Case
  • Wendy Dobson

Meeting Discussion

Working Group Lead Minutes
Best Practices for Data Collection Instructions Todd Based on a presentation at the CDISC Interchange to the CDISC/CDASH leadership team, the project may be renamed as the scope also includes design practices. This will be discussed further offline. The project team is now ready to work on the collection of adverse events. Mary is helping Todd with the initial creation of the white paper as the project team has finished disposition. 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. This was added after the meeting on 29 January.
Clinical Legacy Data Conversion Plan & Report Jane There are two example documents on the Wiki for the team to review. Next step is identifying someone who can work on the Completion Guidelines. The template on the Wiki also has changes that are associated with the current version of the TCG. Also need to start working on the ADRG. 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 has completed the internal review of version three of the package. A planned team meeting is slated for Feb. 1st, which will target a final package to be compiled. After which, the team will work on drafting an overview document. To that end, once all of the relevant materials have been finalized by the team, it will be communicated to the steering committee for review. This is estimated to occur in Q1, but may linger into early Q2. 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 There are going to be two versions of the stylesheet, one for Define-XML 2.0 and Define-XML 2.1. The view/representation is the same but two versions are necessary. The survey can be done in parallel with the Steering Committee review. This is estimated to be in Q1 of this year. 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.
Pooling WHO Drug B3 Format (Best Practices for Integrated Databases) Joyce and Marlo Team has started on an initial draft of the white paper. Joyce and Marlo will not be attending CSS this year.
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.
SDTM ADaM Implementation FAQ Mat and 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.
Standardizing Data within the Inspection Site Selection Process Parag This project can be removed as the goal of the project was met.
Study Data Standardization Plan (SDSP) Jane Wendy working on getting the deliverables published. There is no need for a session at CSS.

US CSS has been scheduled for March 4-6 in Silver Spring. Wendy has scheduled meetings every two weeks with this group to assist in finalizing sessions and presentations.

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] Update CSS opening session slides. They will be sent to the project leads as we get closer to CSS.