Data Consistency: SEND Datasets and the Study Report

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Welcome to the site for the "Data Consistency: SEND Datasets and the Study Report" project group.

This page describes high-level project management details on the group, including purpose, milestones, attendees, and so on. We are part of the FDA/PhUSE Computational Sciences Nonclinical Working Group. Learn more about the larger working group at Non-Clinical Road-map and Impacts on Implementation.

See also:

Working Group Overview

Identify and address inconsistencies between the study report and the SEND datasets. Determine which would be acceptable and which are not. Develop potential solutions for how companies go about fixing the ones that are not deemed acceptable.

Identified Need/Challenge

  • There will be inconsistencies between the study report and the SEND datasets. This is largely due to the fact that many companies/CROs/vendors are creating parallel paths for the generation of SEND datasets and data that goes into the study report.
  • How does one handle data that bypasses the LIMS?
  • Managing interim data (SEND datasets available and study-report data are not)
  • Data coming from different systems (Timing variables in PC and PP, for example)
  • Time stamps (metadata) end up being needed for the SEND datasets because there is no other way to get the date/time
  • Ensuring Trial Summary parameters are populated ("Should Include" plus whatever ones are available) - possible confusion

Project Scope

Potential differences identified so far:

  • Significant figures
  • Controlled terminology
  • Acclimation data that may be in the datasets, but not the study report
  • Body weights and clinical signs data on TK (or other special groups) animals collected, but not in report
  • Issue of data for replacement animals that may not be in report, but is in SEND data
  • Pooled data and calculation of means in study report, but not in SEND datasets
  • Calculated values not in raw data, but calculated upon extract for report, but not SEND datasets
  • SENDIG and Permissible variables - there is confusion around "Permissible"
  • Inclusion of lab values proceeded by "<" or ">" in report calculations but missing in LB - LABRESN
  • Actual date/time in data vs. study day in report (also format of ISO 8601 vs. report format)
  • Lab may report absolute and relative differentials, but only absolute values are reported
  • Body weight, blood pressures, body temps data may be collected for animal welfare issues, but never reported, but is in the SEND datasets. Note this is in addition to the protocol driven bodyweights and body temps, therefore it looks as though we have duplicates or unscheduled collections.
  • Other tests collected as per SOPs and are not included in study plan, included in the SEND data, may or may not be included in the report. (SOP driven data collection, not reported)
  • Process information is collected as part of the necropsy. “Animal Identification, General Observations" collected as SPECIMENS as per confirmation SOP, in SEND datasets but not in the report.
  • LB tests such as IBIL, DBIL and TBIL collected are in report only if above a certain value, but all values may be in SEND dataset.

Categorizations

  • Cannot be Fixed
  • Should be Fixed
  • Easily Fixed

Vision

Plans

  • Meet biweekly until at least subteams are formed, then re-evaluate
  • Discuss possible subteams after issues/challenges/differences have been categorized/grouped

Milestones

  • Identify examples of study report and SEND data set differences April
  • Prioritize identified differences May
  • Identify root cause for differences June
  • Seek FDA input for tolerance July
  • Provide standard language for differences in the NSDRG fro acceptable differences August
  • Provide solutions for differences that are deemed not acceptable September


Tasks

Deliverables

  • Develop a list of acceptable inconsistencies between the study report and the SEND datasets.
  • Develop potential solutions for how companies go about identifying and fixing the ones that are not deemed acceptable.
  • Provide standard language for explaining these in the SDRG.

Test Submission Forum

Link to Team Workbook

Go to the following link to see the team workbook. Take note to open the most recent version: ==

File:Examples of Date consistency issues.xlsx

Link to Draft White Paper

[to Draft White Paper]

Link to 2018 CSS Poster

[[1]]

Participation Needs

The team was established at the PhUSE CSS March 2016.

Call for participation!

What is the commitment?

  • Time (minimum of 1 hour every two weeks for team meetings, up to 3 hours / month)
  • Expected to contribute, not just be a spectator
  • Contribution of viewpoints and content
  • Wiki - creating/reviewing page content

If you would like to participate, please contact the co-leads for this group: Fred Wood or Maria Francomacaro

Work Group Participants

Reach out to a participant with new scenarios to add to this Wiki.

Co-leads:

  • Fred Wood, Independent Consultant
  • Maria Francomacaro, Merck

Participants:

  • Brian Argo, MPI
  • Catherine (Cathy) Roy, Merck
  • Carol Spicer, Smithers Avanza
  • Christy Kubin, MPI
  • Debra Oetzman, Instem
  • Don Fish, Pfizer
  • Kathy Brown, Sanofi
  • Lindsy Eickhoff, BASi
  • Michael Rosentreter, Bayer
  • Wenxian Wang, Xybion

Conference Calls and Minutes

Our first telecon will be scheduled for the first week of April. Contact a co-lead for further details!

Test Submission Forum Minutes



Last revision by Mariafranco613, 2018-06-19