Traceability Meeting Minutes

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Full Team Meetings

August 27, 2014

Attendees: Paul Bukowiec, Erica Davis, Marcelina Hungria, Bhanu Kannan, Jingyee Kou, Jane Lozano, Sandra Minjoe, Eileen Navarro, D'dra Octaviano, Tanja Petrowitsch, Mario Salas


  • Reviewed high level status of sub-team activities
    • Define 2.0 has an extension for analysis results metadata that will be out for public review. Our Define.xml white paper will need to be revised to reflect changes in the standard
    • The updated Basic Linear Data Flow white paper should be ready for posting to the wiki prior to the annual PhUSE meeting in London
    • The following changes were recommended to the Study Level Traceability white paper - Paul to update
      • Clarify that the technical conformance guide is currently a draft document
      • Introduce the notion that these recommendations should not replace sponsor communication with the FDA as individual reviewers may have different needs/expectations. Suggest early communication of standards plans
    • Integration Level Traceability white paper development has not started - co-leads to reach out to Natalie
    • The Legacy Data Conversion Plan Template is coming along nicely. Sub-team needs to add completion guidelines and examples
  • Eileen mentioned that the FDA is in the process of reviewing PhUSE deliverables and she is part of the Optimizing the Use of Data Standards deliverable review. As soon as comments are available, she will share with us.
  • Sandra and Tanja will be presenting at the annual PhUSE meeting in London on the topic of traceability and data flow. The scope of the presentation will cover many of the topics included in our white papers. They will also be providing a high level summary of our deliverables

Next Meeting: Wednesday, October 22, 2014, 11:00 AM EDT

Pbukowiec 14:05, 29 September 2014 (CDT)

June 18, 2014

Attendees: Paul Bukowiec, Marcelina Hungria, Bhanu Kannan, Kristie Kooken, Jingyee Kou, Claudia Meurer, Sandra Minjoe, Krishna Valaboju


  • Reviewed high level status of sub-team activities
  • Paul to follow up with Natalie on status of Integration Level Traceability Sub-Team
    • Scheduling of kick-off meeting
    • Suggest using Study level traceability White Paper as a reference to ensure compatibility between the two documents
    • See if additional help is needed
  • Paul to follow-up with Jane to see if she can post notes from the Legacy Data Conversion Plan sub-team meetings to the Traceability wiki site
  • Agreed that sub-teams will post their final versions of a deliverable to the Project Deliverables section of the wiki site. There is no need for full Traceability team review prior to this step. Will add a note in the Project Deliverables header reminding all who view the content to contact the sub-team lead if they have questions or comments.
  • Paul to resend the full team list, including email addresses, to the full team and ask if there are any concerns with posting this to the wiki site

Next Meeting: Wednesday, August 27, 2014, 11:00 AM EDT

Pbukowiec 14:01, 19 June 2014 (CDT)

June 18, 2013

Attendees: Nancy Bauer, Paul Bukowiec, Todd Case, Xin Fang, Marcelina Hungria, Tatyana Kovtun, Karin LaPann, Ed Lombardi, Pratap Malik, Tanja Petrowitsch, Natalie Reynolds, Pam Ryley, Peter Schaefer, Alan Steinberg, Nancy Tanner, Songhui Zhu


  1. Feedback from 'Optimizing the Use of Data Standards' Working Group Lead Meeting
  2. Traceability Sub Team Activity Updates
  3. Review Wiki Site updates
  4. Review and Finalize Current State Analysis
  5. Q&A


  • Shared positive feedback from the Optimizing the Use of Data Standards working group leads on our project progress and use of the Wiki site for updates.
  • Reviewed the Quarterly Traceability and Data Flow status report that was shared with the Optimizing the Use of Data Standards Working Group leadership team: Quarterly Status Report (Q2)
    • A question had been raised about incorrect use of CDISC standards within one of the traceability references from a public meeting.
    • Should we add a comment within the summary of traceability references table to call out the error and provide the correct usage?
    • A broader question about the criteria used for inclusion of public meeting references was asked
    • Traceability search subteam confirmed that they do not include references in which they feel the traceability recommendations are questionable
    • The subteam maintains a separate spreadsheet that contains all references searched
    • We agreed that we should include a disclaimer in the summary of traceability references table stating that we did not validate the references to the use of industry standards within the public meeting documents. This approach was preferred over commenting on any specific discrepencies found.
    • We also agreed that we should include the criteria for inclusion of public meeting references in our table header, along with the disclaimer.
  • Reviewed the draft Current State Analysis document
    • It was asked if we should put the annotated CRF box before the (e)CRF data cylinder in the basic linear data flow diagram. We agreed that we should leave as is, but clarify that the annotated CRF refers to the CRF database to tabulation dataset annotation and not the (e)CRF annotation used to build the EDC database.
    • We agreed that we should move the last paragraph of the problem statement to the beginning of the section. The paragraph introduces context not previously mentioned and all agreed that it is better to lead with this information as opposed to concluding with it.
    • Add explanation as to why the annotated CRF box is not included in the non-linear data flow diagram.


  1. Natalie Reynolds, or designee, to update the summary of traceability references table to include disclaimer and selection criteria
  2. Natalie Reynolds, or designee, to share full traceability search table (including references not posted to the wiki site) with full traceability team. This is for team use only and not for public posting.
  3. Paul Bukowiec to update the current state analysis document per comments and post to the wiki site.

Pbukowiec 08:49, 19 June 2013 (CDT)

March 2013 CSS 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

Co-Lead Meetings

July 31, 2014

Attendees: Paul Bukowiec, Jane Lozano, Sandra Minjoe, Tanja Petrowitsch


  • Sandra and Tanja will be presenting at the Annual PhUSE conference in London and will have an opportunity to provide an update on Traceability and Data Flow activities
  • Sandra and Tanja will draft a slide deck and send to co-leads to complete updates on sub-team activities
  • Updated the Objectives and Timelines section of the Traceability wiki site to reflect latest information
  • Paul to notify Jeff Conant that the site has been updated
  • Paul to post full team list to wiki site

Pbukowiec 11:30, 4 August 2014 (CDT)

October 25, 2013

Attendees: Paul Bukowiec, Jingyee Kou, Sandra Minjoe

Agenda: Assess overall project status and identify next steps


  • Although sub-team activities are progressing, they have slowed down due to availability of participants. This is to be expected given volunteer nature of the work. Overall team particpation is now down to about 5-10 key contributors which adds to the delays.
  • This time of year is also challenging with CDISC Interchange, and other conferences, combined with holidays and end of year business prioirites taking precedence. Sandra suggested that a formal mid-year CSS/PhUSE face to face meeting in collaboration with the CDISC Interchange may be a good way to re-energize teams and allow more participants to attend. Sandra will present the idea to Chris Decker to get his thoughts on possible next steps.
  • In the meantime, Sandra and Paul will work with the current Basic Linear Data Flow sub-team to finalize the basic linear data flow white paper. This smaller sub team may have the capacity to then generate our larger white paper on study level traceability.
  • Since overall participation is down (only 3 attendees at the last full team meeting), we will cancel the monthly full team meetings. Sub-team and Co-lead meetings will continue.
  • It seems that Tuesday's may not be the best day for our co-lead meetings. Will explore other options, maybe Monday's?
  • In lieu of full team meetings, co-leads will update the status report on a monthly basis, post to the team wiki site, and notify the full team via email that it is available for their review.


  1. Sandra to contact Chris Decker about possible PhUSE/CSS follow up meeting in collaboration with CDISC Interchange
  2. Paul to incorporate comments on latest draft of the Basic Linear Data Flow White paper and schedule meeting with sub-team to finalize.
  3. Paul to cancel Full team meetings and notify all of plan moving forward.
  4. Paul to propose options for new day/time to hold co-lead meetings

Pbukowiec 11:38, 30 October 2013 (CDT)

September 24, 2013

Attendees: Paul Bukowiec, Jingyee Kou, Sandra Minjoe, Tanja Petrowitsch

Agenda: Review sub-team activities


  • Discussed the possibility of having a team face to face meeting at the CDISC Interchange in November where we could work on the Traceability at the Study Level white paper. Sandra will see if we can obtain a meeting room and also do another poll of the team for availability. Paul will provide responses to his prior prompt for attendance.
  • Work to date on basic linear data flow and FDA document search will provide solid foundation for the Study Level Traceability white paper.
  • For full team call on October 8th, we will update and review the status reports prepared for Optimizing the Use of Data Standards team leads. Traceability co-leads to add their updates prior to October 8th.
  • Sub Team Status Updates:
    • 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.


  1. Paul to send co-leads list of team members who are currently planning on attending CDISC interchange
  2. Sandra to see if we can obtain a meeting room for face to face meeting at interchange
  3. Paul to send latest version of status report to co-leads for updates prior to next full team meeting
  4. All co-leads to update status report

Pbukowiec 15:24, 24 September 2013 (CDT)

Basic Linear Data Flow Sub Team Meetings

July 9, 2013

Attendees: Paul Bukowiec, Todd Case, Ed Lombardi, Sandra Minjoe

Discuss content and format of basic linear data flow white paper


  • Attendees agreed that core scope of the white paper should cover traceability information that is most pertinent to an FDA reviewer
  • The traceability data flow should start with the annotated CRF that corresponds to the tabulation or SDTM datasets, proceed to the analysis or ADaM datasets, and end with the outputs
  • Traceability from raw data collection, or EDC, datasets to the tabulation, or SDTM datasets, would be required for internal processing, but they aren't pertinent to FDA review. We can make reference to this in the white paper.
  • The white paper can include the following key sections: Scope, definitions, and best practices for key traceability steps.
  • We can use the excel table that contains ADaM traceability conventions as a starting point for defining the 'what', 'why', and 'how' for the key steps, but will most likely reformat or transpose the information.
  • Ed volunteered to prepare a first draft of the document by July 31, 2013


  1. Ed to complete first draft of white paper by 7/31/13
  2. Paul to schedule a sub-team meeting on 8/16/13 for review of first draft
  3. Upon receipt of first draft, team to review and provide comments prior to 8/16 meeting

Pbukowiec 13:47, 18 July 2013 (CDT)

June 3, 2013

Attendees: Paul Bukowiec, Todd Case, Ron Fitzmartin, Karin LaPann, Ed Lombardi, Sandra Minjoe, Natalie Reynolds, Akira Soma

Review action items from previous meeting
Review results of traceability searches
Discuss next steps


  • Confirmed that scope of this project’s deliverable (white paper) will not include recommendations for legacy data conversion to CDISC standards. This will be covered in the broader study level data and integrated data white papers. It was suggested that we update the reference to these white papers on the wiki site to include CDISC conversion best practices.
  • We agreed to use Summary of Traceability References (SoTR) table on the wiki site to include findings from CDISC documentation
  • Our white paper should start with the drawing of the linear data flow, starting with (e)CRF data collection and ending with analysis datasets, and identify resources on the SoTR table where more information about traceability considerations can be found. We can include summary information about ‘what’ should be traced and ‘why’, but provide more detailed recommendations about ‘how’ traceability should be documented at the key steps of the data flow (e.g. mechanisms).
  • Reiterated that traceability should be bi-directional – need to be able to trace forwards and backwards.


  1. Paul to update the objectives for our two main white paper deliverables to include reference to CDISC conversions (ASAP) - Complete
  2. Akira, and Karin to update the SoTR table to include their CDISC and CDER Common Issues document searches (due 6/14/13) - Open
  3. Todd to search define.xml file for traceability references and update SoTR table (due 6/14/13) - Complete
  4. Ed to search PharmaSUG 2013 proceedings and update SoTR table (due 6/14/13) - Complete
  5. Natalie to search SAS Global forum 2013 proceedings and update SoTR table (due 6/14/13) - Complete
  6. Todd, Ed and Natalie to forward high level summaries of what, why and how for their searches to Paul (due 6/17/13) - Complete
  7. Paul to consolidate high level summary points into one table prior to 6/21/13 meeting (due 6/19/21) - Partially complete

May 7, 2013

Attendees: Paul Bukowiec, Karin LaPann, Sandra Minjoe, Natalie Reynolds, Akira Soma

Agenda: Kick Off Meeting


  • We agreed that basic linear data flow refers to any scenario where source eCRF data is mapped to some sort of tabulation dataset and then this data is mapped to some sort of analysis dataset, off of which TLF and the clinical study report are produced
It doesn’t matter if the source or target data at any point in the flow is CDISC based
Traceability to and/or from post or parallel processed datasets, i.e. post processed SDTM, will not be considered at this time
  • As a first step, we should review existing documentation on traceability, e.g, ADaM standard.
  • Reviewed the ADaM standard and found references to ‘what’ needs to be traced – data and metadata – and ‘why’.
  • Offline, we will review a subset of documentation to identify ‘what’ is being traced, ‘why’ it is important to trace this information, and if possible, ‘how’ it is traced. We identified core documents for review and distributed amongst the attendees as follows:
a. ADaM documentation – Sandra
b. SDTM documentation – Paul
c. CDASH documentation – Akira
d. FDA documentation, e.g. Common Issues Document – Karin
e. Non-FDA/non-CDISC documentation – Natalie
  • We will schedule a follow up meeting for June 3rd (either 1:00PM or 3:00PM Eastern time) to review results.


  • Reviewers to send results to Paul in advance of June 3rd meeting so that he can consolidate results

FDA Document Review for Traceability

April 26, May 30, and June 14, 2013

Project: Look for traceability references in FDA docs (e.g. Common Issues doc), summarize, and try to address. Focus on documents available on + what Jingyee can find on FDA’s intranet.

Near-term Plan:

  • Review FDA docs and ICH? for ‘trace’, ‘trans’, ‘track’, ‘navigate’, ‘trustworthy’
* Notify others if you find/think of a new word in addition to above
  • Pull out quotes, summarize each doc, and post on wiki table
  • Summarize issues, maybe using data mining tool
  • Prep for white paper

Updates since last meeting: we split up the long document started by Pam. We each will review a set of FDA CDER documents to determine whether each is relevant. For any that are relevant, we will summarize and post to the wiki.

Work assigned to each member:

Name Attended 26APR2013 Attended 30MAY2013 Attended 14JUN2013 Work Done/TBD
Sandra Minjoe X X X Searched CDRH but found no references. Will send out whenisgood and schedule next meeting. Will review/summarize a chunk of references from Pam’s doc and post any relevant ones to wiki.
Anthony Chow X X X Sent out a Googledoc, determining we can use it. Suggests using mining tool to search through documents and find common phrases. Searched through ICH and EMA, found several references, and updated wiki. Will review/summarize a chunk of references from Pam’s doc and post any relevant ones to wiki.
Cathy Bezek X Will finish search of CDER with Pam, and then determine who will update wiki.
Jingyee Kou X X Will help CBER searching with Tammy, including internal docs not readily available to non-FDA. When ready, will work with Tammy to add material to wiki.
Karin LaPann X Will review/summarize a chunk of references from Pam’s doc and post any relevant ones to wiki.
Mikkel Traun X Will post recent PhUSE presentations to the wiki. Will review/summarize a chunk of references from Pam’s doc and post any relevant ones to wiki.
Nancy Tanner X X Will review/summarize a chunk of references from Pam’s doc and post any relevant ones to wiki.
Pam Ryley X Started a doc of CBER search results and sent to group.
Songhui Zhu X
Tammy Steele X Will search CBER, with Jingyee, then determine who will update wiki.
Todd Case X X Posted summary of define.xml spec from CDISC. Will review/summarize a chunk of references from Pam’s doc and post any relevant ones to wiki.

Meeting Purpose

Month Day, Year





Last revision by Pbukowiec,09/29/2014