SEND Implementation User Group Minutes 2020-06-16

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For other minutes, see the SEND Implementation User Group Minutes page.

Logistics

Meetings

Meetings occur every 4 weeks, at 1-2pm EDT.

Attendance

Participant Attended
Troy Smyrnios X
Debra Oetzman
Ahn Diep
Audrey Walker X
Bill Houser X
Brett Coupland
Brian Argo
Cheryl Sloan
Christy Kubin
Graham Baxter
Jason Rogers
Jeff Cao
Jeff Foy
Lou Ann Kramer
Mike Wasko X
Rick Thompson
Rihab Kordane
Seran Yusuf X
Virginie Ora
Wenxian Wang
William Moseley
Yukinori Shiroo



Minutes

Forum

Links:

Review Forum


Current Issues

  • DRVFL for OW (here)
    • Previously answered
    • New reply
      • Answered
  • MA UNREMARKABLE, ALL TISSUES (here)
    • Answered
    • New reply
      • Answered




Open Issues

  • None


Review News Page

SEND Implementation News

  • Webinar post re: CDER - but postponed
  • FDA wednesday virtual thing - posted
  • Animal rule accepted (catalog not updated yet) - posted

Wiki

  • OPEN ITEMS
    • TRC effective?
      • Once TRC is actually published (officially), update any FAQ items mentioning "reject"
      • 2019-09-10 Update: expected end of year (probably)

FAQ structure re-org

  • Re-org after 7 years to bucket things
  • Drafted new outline in meeting
  • Troy to send out outline for review
  • Poster idea - 7 years of Implementation wiki, re-org/refresh

VISITDY deprecation question

requires re-org of structure; would go in general variables-like section, along with DY, etc.

When to populate VISITDY vs --NOMDY (3.1)? Where is VISITDY in 3.1? 3.0: Populate VISITDY per IG. 3.1: 3.1 marks the beginning of the deprecation of the VISITDY variable; SENDIG 3.2 is expected to completely deprecate VISITDY. --NOMDY is the go-forward representation of the reported day in the datasets.

  • Dataset populators should only populate --NOMDY (and expect VISITDY to be phased out)
  • Recipients should ignore VISITDY in favor of --NOMDY.

Actual day is still represented in --DY, and planned/unplanned is represented in --USCHFL (which covers the meaningful part of the planned day concept).

TSPARM/TXPARM

Which TSPARMs should I include?
Which TXPARMs should I include?
There are two sources of recommended parameters to include - the SENDIG's "Should Include" and the FDA's TCG, which calls out certain parameters. You should at least include both of these sets, as well as any that make sense for your study.
*Note: the long name mentioned in the TCG may not always match the version of CT you are using; use the long name from the CT list)

Which CT should I use for TSPARMs?
Which CT should I use for TXPARMs?
The SENDIG calls out some CT for the TS and TX parameter lists. As of 3.1, this is being worked on. If/when you see CT called out in the SENDIG, use it. Otherwise, use your best judgment.

Study report and dataset consistency

    • Working group team catalogued a number of inconsistencies between study report and datasets and published white paper to wiki:

https://www.phusewiki.org/wiki/index.php?title=Data_Consistency:_SEND_Datasets_and_the_Study_Report

    • Content of white paper is static
    • Keeping it evergreen
      • New page that has bullets and "live" table of high-value consistency items
      • Use channel of forum as means to add new items
      • Put out there that people can submit ideas for it to impl team

Loose notes: Data Consistency: SEND Datasets and the Study Report Wiki   • The “Data Consistency: SEND Datasets and the Study Report” Working Group was formed at PhUSE CSS 2016 to identify inconsistencies that were being discovered between nonclinical datasets and study reports and provide recommendations for action. • Team members drew from experience, as well as scenarios that surfaced through the Nonclinical FDA Fit-for-Use Pilot (SEND 3.0), to draft a list of discrepancies which was then assessed and categorized based on the item’s potential impact to study data interpretation. Conclusions drawn from the assessment became the basis for recommendations. • As work progressed, the team realized that identification of new inconsistencies and our evolving understanding of regulatory needs could make a traditional white paper obsolete. With this in mind, the idea of the paper was transformed into a live wiki page and members were encouraged to add new examples and solutions for newly identified data inconsistencies. This functionality still exists in the WIKI for possible future updates.   {Table of biggest things} - add column for solution exists (ideal vs nsdrg case) 1. --LLOQ and --ULOQ cases -> Remain as a consistency issue (low), but also FAQ item with answer (--CALCN) guidance exists in TCG. solution: exists 2. RELREC holes -> should collect correlations. solution: include collected relationships 3. Day 0/1 -> Remain consistency, but also FAQ to add nSDRG. solution: short=nsdrg note, long=go to day 1 base 4. Text diff between -> lower consistency, no FAQ item needed. solution: short=nsdrg effect, long=CT alignment 5. Path modifiers -> high consistency, no FAQ item needed. solution: short=, long=CT alignment 6. Severity -> low consistency. FAQ item on point scale adaptability. solution: short=nsdrg, long=newer CT is adaptable and can cover it

Consistency items - origin: ambiguity - > accidentally multiple ways to do it multiple ways to do it in guide Consistency items - mitigation: proposed/preferred way acknowledged variability

Link to the Wiki Page: https://www.phusewiki.org/wiki/index.php?title=Data_Consistency:_SEND_Datasets_and_Study_Report_Wiki


{ISSUES -> move to FAQ}


General

Action Items

Responsible Task Timeframe
Troy FAQ Outline Next meeting

Last revision by Troy.smyrnios, 2020-06-16