Traceability and Data Flow

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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 intensify 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:
If you have any questions or comments, please contact the deliverable lead - listed in the Objectives and Timelines table


Summary of Traceability References

Traceability: Current State Analysis

Preliminary Recommendations for Traceability Documentation using Define-XML 2.0

Traceability: Best Practices for Basic Linear Data Flow NEW VERSION: Now includes Recommendations

White Paper: Study Level Traceability in a Non Linear Data Flow NEW: Updated October 2014

Project Updates

Updates on Traceability and Data Flow activities can be found in the team status reports provided below

August 2013

September 2013

October 2013

December 2013

2014 Computational Science Symposium Agenda

Meeting Minutes

Team Meetings


Traceability Meeting Minutes


Legacy Data Conversion Plan Meeting Minutes


Objectives and Timelines

Ongoing Project Objective Timeline Lead Status
Search for, summarize and interpret traceability references found in the public domain (e.g. conference papers, CDISC), including FDA docs (e.g. Common Issues Document) June, 2013 (with continued updates) Sandra Minjoe
Natalie Reynolds
Initial reference search complete, see link in project deliverable section.
White paper: Integration traceability for FDA needs, including best practices for non-linear data flow due to legacy to CDISC conversion TBD Tanja Petrowitsch Small team kicked off, December 2014. Will walk through plan and determine structure and tasks to do at the face-to-face.
Legacy data conversion plan template Q1 2015 Jane Lozano Ongoing - Looking for feedback at the March 2015 face-to-face
Traceability and Data Flow within ADaM TBD Sandra Minjoe To be kicked off at the March 2015 face-to-face
Completed Project Objective Timeline Lead Status
White paper: Current state analysis, action points, high level recommendations for phuse wiki posting June, 2013 Paul Bukowiec Complete
Review Define 2.0 documentation and identify options for traceability documentation, including what to put in "comments" Summer, 2013 Tanja Petrowitsch Completed, December 2013
White paper: Traceability best practices for linear data flow (basic model) Summer, 2013 Paul Bukowiec Completed, December 2013
White paper: Study level traceability for FDA needs, including best practices for non-linear data flow due to legacy to CDISC conversion August 2014 Paul Bukowiec Complete
Update Basic Linear Data Flow WP to include best practice recommendations Fall 2014 Sandra Minjoe Completed, December 2014
Present workstream activities at Annual PhUSE meeting in London October 2014 Sandra Minjoe and Tanja Petrowitsch Completed, October 2014
Present paper at Annual PhUSE meeting: 'Traceability: Plan Ahead for Future Needs' October 2014 Sandra Minjoe and Tanja Petrowitsch Completed, October 2014

Project Team

Project Leads

Name Role Organization E-mail
Jane Lozano Industry Co-Lead Lilly j.a.lozano (at) lilly.com
Sandra Minjoe Industry Co-Lead Accenture Life Sciences sandra.minjoe (at) accenture.com
Tanja Petrowitsch Industry Co-Lead Bayer Pharma AG tanja.petrowitsch (at) bayer.com
Natalie Reynolds Industry Co-Lead Lilly nreynolds (at) lilly.com
Jingyee Kou FDA Liaison FDA jingyee.kou (at) fda.hhs.gov

Full Team List

Archived Content



March 2013 F2F Meeting Notes: CSS Traceability 2013 F2F