Difference between revisions of "Traceability and Data Flow"

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'''March 2013 F2F Meeting Notes: [[Media:CSS_Traceability_2013_F2F.pdf|CSS Traceability 2013 F2F]]'''
'''March 2013 F2F Meeting Notes: [[Media:CSS_Traceability_2013_F2F.pdf|CSS Traceability 2013 F2F]]'''
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[[Traceability Meeting Minutes]]
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= Objectives and Timelines =
= Objectives and Timelines =

Revision as of 06:55, 10 June 2013

Project Overview

It is always a challenge for the results in the clinical study report to be able to trace back to the original raw data source. The traceability challenges intensity when raw data is converted to SDTM after the fact, while analysis datasets and the study report trace back to the original raw data source. This project will discuss and define traceability considerations and best practices for study level dataset and integrated datasets conversion for a variety of different data flow scenarios.

Project Deliverables

The following deliverables are available for review:

Summary of Traceability References

Project Updates

Since the March F2F meeting of the Traceability and Data Flow project team at the annual PhUSE/FDA meeting, the group has been active with the following:


  • Developed and adding to a list of documents in the industry that discuss traceability
  • Developing a white paper on current state analysis, action points, and high-level recommendations

Sub-group Activities

  • Searching industry publications that describe traceability and the need for it
  • Searching documents produced by regulatory agencies and standards groups for traceability references
  • Reviewing the define.xml 2.0 document for traceability, in preparation for a white paper with recommendations
  • Developing a white paper on traceability needs in a basic data flow

Meeting Minutes

Web Meetings

Work stream minutes - Traceability in Regulatory Agency and Standards Groups:

March Face-to-Face Meeting

Meeting highlights

  • 29 participants signed up for on going support of the project
  • 4 sub teams were initiated to complete short term deliverables
  • Project objectives and timelines were updated (see below)
  • Current state analysis drafted during F2F

Next Steps

  • Project team leads to meet in April to prepare final draft of current state analysis
  • Current state analysis to be sent to full team for off line review - April/May
  • Schedule full team meeting to finalize current state analysis, review project deliverables/work in progress, and establish team meeting schedule - May/June

March 2013 F2F Meeting Notes: CSS Traceability 2013 F2F
Traceability Meeting Minutes

Objectives and Timelines

Objective Timeline
White paper: Current state analysis, action points, high level recommendations for phuse wiki posting June, 2013
Search for, summarize and interpret traceability references in FDA docs (e.g. Common Issues Document) April, 2013 (with continued updates)
Review Define 2.0 documentation and identify options for traceability documentation, including what to put in "comments" Summer, 2013
White paper: Traceability best practices for linear data flow (basic model) Summer, 2013
FDA document review (interpretation, comments to FDA) When available
White paper: Study level traceability for FDA needs Initial draft for FDA review, September 2013, Publication on wiki, November 2013
Produce poster for 2014 phuse/FDA meeting Q1, 2014
White paper: Integration traceability for FDA needs TBD, 2014

Project Leads

Name Role Organization E-mail
Paul Bukowiec Industry Co-Lead Millennium Pharmaceuticals, Inc paul.bukowiec@mpi.com
Sandra Minjoe Industry Co-Lead Accenture Life Sciences sandra.minjoe.accenture.com
Tanja Petrowitsch Industry Co-Lead Bayer tanja.petrowitsch@bayer.com
Natalie Reynolds Industry Co-Lead Lilly nreynolds@lilly.com
Jingyee Kou FDA Co-Lead FDA jingyee.kou@fda.hhs.gov

Archived Content