#### Teleconference Information  Clinical Trials Management Systems (CTMS) Workspace Call Tuesday, October 24, 2006 12:00 PM -- 1:00 PM EST Moderator: Meg Gronvall

**Executive Summary**

The CTMS Workspace received an announcement of the C3PR Release 2
project award to Duke University and an introduction to its team
members. The WS discussed the upcoming joint CTMS/TBPT/DSIC Workspace
Face-to-Face Meeting in November 2006, including the tentative agenda, a
SIG Lead dinner, and SIG breakout sessions.  The WS discussed abstract
and exhibit application submissions for the 2007 caBIG™ Annual Meeting.
Meg Gronvall gave an update on the CRIX initiative, highlighting the key
points of the last CRIX Steering Committee meeting. The caXchange and
Study Calendar development teams gave demonstrations of their projects,
and the Protocol Lifecycle Tracking demo slides will be sent to the
listserv in lieu of a demo due to time constraints.

**Key Outcomes/Decisions**

-   The C3PR (Release 2) project was awarded to Duke University.

-   The CTMS/TBPT/DSIC Joint Workspace Face-to-Face Meeting will be
    November 27-30, 2006, at the Natcher Conference Center on the NIH
    Campus in Bethesda, MD. The CTMS agenda is currently being drafted.

-   The deadline for caBIG™ Annual Meeting abstract submissions has been
    extended through tomorrow, Oct. 25^th^.

**Meeting Materials\
**

-   caXchange Project Overview:
    [https://gforge.nci.nih.gov/docman/view.php/318/6456/caXchange%20(Lab%20Hub)%20Project%20Overview_20061024.ppt](https://gforge.nci.nih.gov/docman/view.php/318/6456/caXchange (Lab Hub) Project Overview_20061024.ppt)

-   Patient Study Calendar Overview:
    <https://gforge.nci.nih.gov/docman/view.php/318/6458/PSC_Overview_R2-R3_20061024.pdf>

-   Protocol Lifecycle Tracking Overview:
    [https://gforge.nci.nih.gov/docman/view.php/318/6459/Protocol%20Lifecycle%20Tracking%20Status%2020061024.ppt](https://gforge.nci.nih.gov/docman/view.php/318/6459/Protocol Lifecycle Tracking Status 20061024.ppt)

**Action Items**

  ---------------- ------------------------------------------- -----------
  **Assigned To**  **Description**                             **Due
                                                               Date**

  WS Participants  Register for CTMS Face-to-Face Meeting (Nov ASAP
                   17-19, 2006) online at the caBIG™ website   

  SIG Leads        Email Meg Gronvall at                       ASAP
                   gronvall_margaret@bah.com regarding         
                   preference for a Monday or Tuesday SIG Lead 
                   night dinner at the November Face-to-Face   

  SIG Leads        Send requests for SIG breakout meetings at  COB Oct 27
                   the Face-to-Face meeting to Daniela Smith   
                   at smith_daniela@bah.com                    

  Smita Hastak\    CTMS Development Team demo presenters       Before next
  Sean Whitaker\   should send demo slides from today's        call
  Stephen Reckford meeting to Daniela Smith for CTMS WS        
                   listserv posting                            

  WS Participants  Send any objections or changes to the Sept  COB Oct 25
                   26 CTMS WS minutes to Daniela Smith         
  ---------------- ------------------------------------------- -----------

**Attendees**

  ---- ------------ -------------- ---------------------------------------
       **First      **Last Name**  **Affiliation**
       Name**                      

  1    Christo      Andonyadis     NCI

  2    Robert       Annechiarico   Duke University

  3    Rhoda        Arzoomanian    University of Wisconsin

  4    Harsh        Bal            Booz Allen Hamilton

  5    Bill         Banks          Duke University

  6    Lloyd        Barnhill       Pfizer

  7    Barry        Brown          University of Minnesota

  8    Troy         Budd           DCP

  9    Steven       Chent          Wake Forest

  10   Janice       Chilli         SAIC

  11   Don          Connelly       University of Minnesota

  12   Mary         Cooper         SAIC

  13   Brian        Davis          3rd Millennium

  14   Suranjan     De             CTIS

  15   Rakesh       Dhaval         Ohio State University

  16   Stephen      Dorian         RTOG

  17   Assem        El-Ansary      Nortel Government Solution

  18   Sharon       Elcombe        Mayo Clinic Cancer Center

  19   Wes          Fang           MSKCC

  20   Lara         Fournier       OHSU

  21   Douglas      Fridsma        University of Pittsburgh

  22   Steven       Friedman       NCI

  23   Rangaraju    Gadiraju       Nortel Government Solutions

  24   Jay          Greenberg      University of the Sciences in
                                   Philadelphia

  25   Charles      Griffin        NCI

  26   Meg          Gronvall       Booz Allen Hamilton

  27   David        Hanauer        University of Michigan

  28   Smita        Hastak         ScenPro

  29   Julie        Holtzople      Booz Allen Hamilton

  30   Shira        Hoschander     Albert Einstein Center

  31   Andrea       Hwang          UC Irvine

  32   Maryann      Jodoin         Quality Assurance Review Center

  33   Kim          Johnson        CALGB

  34   Me Linda     Johnson        Arizona Cancer Center

  35   Connie       Keefer         CTIS

  36   Michael      Keller         Booz Allen Hamilton

  37   Sharon       Levy           Georgetown University

  38   Elsa         Lin            Georgetown University

  39   Sichen       Liu            National Cancer Institute

  40   Brenda       Maeske         SAIC

  41   Donna        Marinucci      ECOG

  42   Christine    McLaren        UC Irvine

  43   Mukesh       Mediratta      Ekagra

  44   Bob          Morrell        Wake Forest University

  45   Irfan        Murtuza        Booz Allen Hamilton

  46   Thuzar       Myint          Westat

  47   Sorena       Nadaf          Vanderbilt University

  48   Hang         Nguyen         Booz Allen Hamilton

  49   Carrie       Nielson        Arizona Cancer Center

  50   Joyce        Niland         City of Hope

  51   Susan        Pannoni        City of Hope

  52   Vainav       Patel          NCI

  53   Diane        Paul           Patient Advocate

  54   Stephen      Reckford       Nortel Government Solutions

  55   Steve        Riordan        Westat

  56   Karen        Ryan           Booz Allen Hamilton

  57   Mohammad     Sarid          Duke

  58   Linda        Schmandt       University of Pittsburgh

  59   Ann          Setser         National Cancer Institute

  60   Deven        Shah           NCI Contractor

  61   Oleg         Shats          UNMC

  62   Daniela      Smith          Booz Allen Hamilton

  63   John         Speakman       NCI

  64   Anne         Tompkins       Division of Cancer Prevention, NCI

  65   Susan        Varghese       Booz Allen Hamilton

  66   Wendy        Verhoef        ScenPro

  67   Kirsten      Walsh          Nortel Government Solutions

  68   Stephine     Wasielewski    University of Wisconsin

  69   Renee        Web            Northwestern University

  70   Chunhua      Weng           UPCI

  71   Sean         Whitaker       Northwestern University

  72   Hadley       White          Booz Allen Hamilton

  73   Andrew       Winter         Northwestern University

  73   Xin          Zheng          AECOM

  74   Julie        Zhu            Northwestern University
  ---- ------------ -------------- ---------------------------------------

**[Meeting Notes]{.smallcaps}**

**1. Workspace Announcements**

CTMS Workspace Lead Meg Gronvall (Booz Allen Hamilton) announced that
the C3PR (Cancer Central Clinical Participant Registry) project has been
awarded to Duke University. Bob Annechiarico (Duke) introduced the C3PR
team that Duke has proposed which includes individuals from the
Coalition for Cancer Cooperative Studies, Duke Bioinformatics Group,
Duke - CALGB, Mayo Clinic, NC State University, SemanticBits, Wake
Forest University, and Westat. The C3PR(R2) kick-off meeting will be in
the beginning of November. The task order is currently being processed.

**2. Upcoming CTMS/DSIC/TBPT Workspace Face-to-Face Meeting, Nov. 27 -
29**

Meg Gronvall encouraged everyone to register online for the F2F
(Registration URL:
<https://cabig.nci.nih.gov/eventregistration/FTF-11-27-2006>). Meg noted
that the WS leadership has had some discussions regarding the joint F2F
overlap day (Nov. 29^th^). There will be another WS Lead F2F Planning
Meeting this week and an agenda will be distributed for this joint day.
The group has had particular discussions around breakout panels and
discussion topics. The DSIC WS will play a key role in presenting and
moderating the panel discussions and will address privacy and
intellectual property issues.

The CTMS agenda is currently being drafted. CTMS Day 1 will begin at
12:30 PM EST on Mon., Nov. 27^th^, and Meg encouraged participants to
get lunch prior to the start of the meeting.

***Tentative Agenda:***

  ---------------------- ------------------------------------------------
  **Date/Time**          **Topics/Goals**

  Monday, Nov. 27th\     Open plenary, review agenda, talk about issues,
  12:30 -- 5:00 PM EST   program to date, goals, next steps for Annual
                         Meeting, Year 3 activities, UPF and
                         architecture, update for CTWG Initiatives.

  Tuesday, Nov. 28th**\  Demos for development projects and SIG breakouts
  **9:00 AM -- 5:00 PM   (trying to accommodate SIG meetings better as
  EST                    this was the biggest negative feedback from the
                         last F2F meeting), integration issues across
                         CTMS, use cases, Year 4 projection and goals,
                         integration issues across caBIG™ program.

  Wednesday, Nov. 29th\  Joint CTMS/DSIC/TBPT Agenda, high level
  9:00 AM -- 5:00 PM EST overview, overlapping issues, etc.
  ---------------------- ------------------------------------------------

***SIG Lead Dinner***

Meg polled the SIG Leads for attendance at a SIG Lead Dinner Monday or
Tuesday night (Nov. 27 or 28). SIG Leads should email Meg their
preference.

***SIG Breakout Meetings***\
Participants inquired about the SIG breakout meetings and available
times. Meg indicated that a few SIGs have requested such meetings (e.g.
FB and SC SIGs have requested a joint meeting) and we will have extra
rooms available. SIG Leads should continue to send requests for breakout
meetings to Daniela Smith at <smith_daniela@bah.com> (by COB Oct.
27^th^) and Booz Allen will coordinate the details of these meetings so
that participants can schedule their calendars in advance.

**3. caBIG™ 2007 Annual Meeting -- Abstract and Exhibit Application
Submissions**

NOTE: The deadline for abstract submissions has been extended through
tomorrow, Oct. 25^th^ COB.

Participants/groups from the CTMS WS who have submitted abstracts to
date include:

-   Andrea Hwang

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-   Bob Annechiarico

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-   Sean Whitaker (Poster and tech demo)

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-   Stephen Reckford (Posters for C3PR, caMatch, Protocol Lifecycle
    Tracking)

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-   Smita Hastak (Will submit)

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-   Sorena Nadaf (Poster)

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-   caAdapter (Poster and tech demo)

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-   BP SIG (Poster)

**4. CRIX Update**

The CRIX Steering Committee held a meeting on Fri., Oct. 20^th^, that
was well-attended and successful. Meg reviewed the key points submitted
by Mark Adams, caBIG™ Project Manager (Booz Allen Hamilton), who was in
attendance:

-   CRIX is gaining significant ground with NCI, FDA, and NIH
    leadership.

-   Dr. Ken Buetow spoke and noted that relevant program documents have
    been submitted to the Office of General Counsel, the NIH and the
    FDA.

-   Dr. Buetow noted that action to address the needs of the people and
    the government will be completed in weeks not months.

-   Presentations were given on caMatch.

-   Progress reported on underlying software (CRIX, JANUS, etc.).

-   The next CRIX meeting will be in December on the West coast. More
    specified information on structure is hoped to be available by then.

John Speakman (NCICB), who was also in attendance, noted that IBM will
continue to be involved. If there are any other questions regarding
CRIX, please email Meg.

**5. Demo of Current CTMS Development Projects**

Demo presentations were given by CTMS Development Teams (caXchange and
Patient Study Calendar) in preparation for the upcoming F2F. All demo
slides will be distributed to the Workspace via the CTMS listserv.

***caXchange Project - Smita Hastak***

Smita Hastak (ScenPro) presented a high level data flow of the caXchange
project. Smita reviewed the project's integration with existing NCI
projects (including CTOM, BRIDG, caAdapter, and C3PR), the overall
project status, activities completed, and project timeline. The team
completed the first iteration of the project in September 2006, and is
currently in the Construction Phase of the second iteration which will
be completed in early November. Next steps include testing throughout
November, deployment at Georgetown University in early December, and
deployment to production in mid-December.

*Discussion Items:*

-   The module needs dummy clinical data because HL7 v3 requires it.

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-   The goal of caXchange in the long-term is to standardize Units of
    Measure. There is currently no data transformation service, but this
    item has been identified as a next step. Currently Georgetown is not
    able to send pre-v3 data. The caXchange Team is considering how we
    can harmonize between HL7 an caBIG™ Units of Measure.

-   Smita noted that the team plans to identify complete lists of
    elements that need to be standardized and submit to VCDE to create
    the appropriate CDEs. The caXchange team is hoping to work with the
    Architecture WS in the next iteration in using unique identifiers
    across the Grid and de-identification (not currently in scope).

-   The caXchange team has been developing this model over the last 2.5
    -- 3 months. They have submitted the model for semantic integration
    and they submitted the API last night.

***Patient Study Calendar Project - Sean Whitaker***

Sean Whitaker (Northwestern) presented an overview and demonstration of
the Patient Study Calendar (PSC) Module. Sean presented a development
overview, noting that there is a 24 week development period divided into
four releases. The team has been meeting weekly with domain experts to
re-evaluate software developments and incorporate feedback. With each
release, the team does a public demo and encourages feedback. The Study
Calendar is a tool to be used at clinical research centers to manage
activities. Sean also reviewed Roles and Activities of the project team.
Due to time constraints, participants who wanted to view the demo during
today's meeting stayed on the call past 1 PM.

Release 3 will be coming October 30, 2006, and includes:

-   Improved user interface for creating and editing study templates

-   All interfaces for managing user access to templates in a multi-site
    environment

-   Assignment of participants to arms

-   Management of participant schedule

A Release 3 demo will be given at the next SC SIG telecon on Nov. 6^th^.
Release 4 will feature reporting, auditing, and quickly accepting User
Acceptance Testing feedback.

***Protocol Lifecycle Tracking Team - Stephen Reckford***

Stephen Reckford (Nortel) will send the Protocol Lifecycle Tracking demo
slides to Daniela Smith for listserv posting, in lieu of a demo due to
time constraints.

**6. Any Other Business**

Please send any objections or changes to the Sept. 26 minutes to Daniela
Smith in the next 24 hours, after which they will be approved as final.

*Post-Meeting PSC Demo Questions/Feedback:*

-   Joyce Niland (COH) noted that in the SOW there was no indication
    that there would be notification to participants about giving them
    the calendar. Sean said this will be a tool used for conducting
    trials, and at this point they are not giving any information to
    participants. After the release we will show participants all
    upcoming information.

-   Ann Setser inquired in regards to the arm slide: *Will this
    information come from already abstracted protocols? When the arms
    change, will you make amendments?* Sean confirmed this was correct
    and noted that they are building an editing function for Release 3
    or 4.

-   Me Linda Johnson (Arizona) asked about the modeling software used.
    Sean noted that the SC was modeled with Hibernate and that the
    source code is posted on the GForge site.

**Next Meeting:**

CTMS WS Face-to-Face Meeting (No November WS Teleconference)

Monday, Nov. 27^th^ -- Wednesday, Nov. 29^th^