PhUSE Working Group RGvD - Meeting Minutes 2015-06-09

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  • Sandy (Astra Zeneca)
  • Kiran (Roche)
  • Steve (Cytel)
  • Ying (Genentech)
  • Wei (Gilead)
  • Janet (Merck)
  • Ellen (Merck)


  • Admin/Updates
  • Discuss SDRG template section 3


  • Sandy met with Mat Bryant who heads up Best Practices. We are the only BP group that has started meeting so far. Mat will head up a group for lab challenges and the Trial Design group isn’t likely to happen this year as nobody has volunteered to lead.
  • We are working on getting a Wiki site set up to post our internal notes and share documents.
  • There is a PhUSE webinar on Thursday to give team updates.

SDRG discussion:

  • Section 3.1/Overview:
  • Primary and secondary endpoints as separate sections? They are needed in ADRG. SDRG also has an area for this – is the duplication needed? Maybe, for medical reviewers using the SDTM data.
  • Do these guides work for integrated data (ISS/ISE)?
  • Include data flow diagrams for non-standard data flow (i.e. ADaM not created from SDTM, extension studies).
  • Section 3.2/aCRFs:
  • unique forms – annotating versus submitting (submit all and annotate just the unique)
  • common to submit only the unique forms
  • bookmarking domains and visits
  • guidelines aren’t clear on headers to use
  • refer to ‘topics’, so ‘domains’ may be discrepant
  • order bookmarks alphabetically in the by-domain section
  • use “domains” or “topics” for bookmark header?
  • Suggest wording change in SDRG completion instructions
  • Do we annotate by domain or by CRF topic/module?
  • Suggest to use the form name and change header to “CRF Topics” (not “Domains”)
  • Section 3.3/Subject Domains:
  • Note the primary/secondary efficacy here – flag using different codes….P=primary, S=secondary? Would need footnote or key to identify the meaning of these codes.

3.3 SDTM Subject Domains

Dataset - Dataset Label Efficacy Safety Other SUPP-- Related Using RELREC Observation Class
AE – Adverse Events X Events
DM – Demographics X Special Purpose
DS – Disposition P X Events
EX – Exposure S X Interventions

P=primary, S = secondary

  • Observation class needed? Yes, to help identify structure, particularly for custom domains.
  • Typo in instructions at top of page 9…2.2 should be 3.2. (Note to SDRG team)
  • SUPPQUAL tables not needed?
  • Check with team on reason for including them in the template.
  • CBER wanted to see all SUPPQUAL in one place
  • CBER data interpretation guidelines lists qualifiers with reason they’re included.
  • If including, suggest to add a column to explain why they are mapped to SDTM.
  • Reasons may be repeated, such as “data not available in standard variables”, “required for analysis”, etc.
QNAM Description QLABEL Explanation for Inclusion
LBCVRESC Character result in conventional units Conventional units needed for additional analysis
LBCVRESU Conventional unit Conventional units needed for additional analysis
LBCVNRLO Reference range lower limit in conventional units Conventional units needed for additional analysis
LBCVNRHI Reference ranges upper limit in conventional units Conventional units needed for additional analysis
  • Sections 3.3.x:
  • Derivations should be in the computational algorithms in define.xml only
  • Unless there are special characters, images?
  • Hyperlink from define.xml in that case to specific section of RG if possible
  • Explanation for origin values – how they are determined, e.g. Assigned versus Derived.
  • Would this be domain-specific or general? If general, then note in 3.1, not here.
  • Large table or lot of detail for a dataset – put in an appendix and include a hyperlink (rather than within a section 3.3.x)

Next meeting: 2015-06-23