Quarterly Status Report
Reporting Period
Project Title
Working Group CoLeads
Project Lead(s)
Prepared By
August - September, 2013
Optimizing the Use of Data Standards - Traceability and Data Flow
Industry: Scott Bahlavooni
Jeff Conant
PM
FDA: Jingyee Kou, Steve Wilson
Paul Bukowiec, Sandra Minjoe, Tanja Petrowitsch,
Natalie Reynolds, Jingyee Kou
Paul Bukowiec
1 PROJECT STATUS SUMMARY
TASKS ACCOMPLISHED




Basic Linear Data Flow white paper is 2/3 complete. Team is working on final 2 sections with the goal to
be complete by first week of October. Will send to full team for review shortly thereafter.
Traceability Reference Search is essentially complete, but ongoing updates will be made as new references
become available.
FDA document review sub-team has started drafting a white paper to summarize results. Once the draft is
complete, it will be sent to Jingyee for FDA co-lead input.
Define 2.0 sub team has a first draft of their summary report and will be meeting first week of October to
review/update.
PLAN FOR NEXT REPORTING PERIOD




Finalize “Basic Linear Data Flow” white paper.
Finalize white paper to summarize traceability references in regulatory documents and make
recommendations.
Finalize white paper to make traceability recommendations for define.xml 2.0.
Initiate first draft of white paper on study level traceability for FDA needs – see project milestone 7, below
2 PROJECT MILESTONE STATUS
Expected
Completion
Date
Issues Exist
(Yes/No)
Project Milestones
1
Current state analysis white paper
Completed
3/13
6/13
No
2
Search for, summarize and interpret traceability
references found in the public domain
Review Define 2.0 documentation for traceability
options and prepare white paper
Completed*
3/13
6/13
No
In Progress
3/13
Q4/13
No
4
White paper: Traceability best practices for linear
data flow (basic model)
In Progress
5/13
Q3/13
No
5
FDA document review
Ongoing*
6
In Progress
8/13
12/13
No
7
White paper summarizing results of FDA
document review
White paper: study level traceability for FDA
needs
Pending
6/13
11/13
Yes
8
Produce poster for 2014 FDA/PhUSE meeting
Pending
TBD
Q1/14
No
9
White paper: Integration traceability for FDA
needs
Pending
TBD
TBD
No
3
Status
Baseline
Start Date
#
-1-
No
Quarterly Status Report
3 PROJECT ISSUES SUMMARY
#
Issue Description
White paper on study level
traceability for FDA needs
1
Impact Summary (Milestone,
Schedule Scope, Resources,
Space…)
Action Steps
Schedule – will most likely
not be completed in
November 2013
Ask Basic Linear Data Flow subteam to transition to this white paper
once complete with milestone #4
2
3
4
5
6
4 PROJECT RISK SUMMARY
#
1
Risk Description
Mitigation Strategy
N/A
2
5
ASSISTANCE REQUESTS
#
Description including reference to milestone impacted, if needed
1
N/A
6
MISCELLANEOUS PROJECT NOTES
5.1.1.1
Action Requested
* As new documents or references are posted or made available, they will be added to the reference document.
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