#### Teleconference Information

CTMS/RDX SIG

**Wednesday February 21st, 12:00 PM EST**

**Moderator: Susan Varghese (BAH)**

**SIG Leader: Rhoda Arzoomanian (UWisc)**

**Scribe: Lara Fournier (OHSU)**

#### Meeting Materials:

#### Agenda 022107.doc - (email from Rhoda)

#### meeting summary20070214draft.doc (sent in e-mail from Lara)

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Event ID: RDX_SIG

#### Key Decisions and/or Outcomes

1.  Presentation of ECOG CDE Search tool - Rick

2.  Presentation and overview of other summaries required for CCSG - Bob
    M.

#### Executive Summary

Rick started with a presentation of the ECOG CDE search tool and
mentioned that the code and technical manual can be made available if
folks want to pick it and enhance it. Bob presented an overview of the
several of the other summaries required for CCSG (outside of 3&4) and
highlighted some of the issues they encountered. Next meeting (Mar
14th), the group will get an overview of the caDSR and activities of the
VCDE WS.

#### Action Items

+----------------+--------------------------------------+-------------+
| ##             | #### Description                     | ##          |
| ## Assigned To |                                      | ## Due Date |
+----------------+--------------------------------------+-------------+
| #### Lara      | ####                                 | ####        |
|                | Finalize draft meeting minutes 2/14/ |  03/12/2007 |
|                | 07, create draft for Feb 21 meeting. |             |
+----------------+--------------------------------------+-------------+
| #### Rhoda     | Get old minutes from Bill            | ####        |
|                |                                      |  03/14/2007 |
+----------------+--------------------------------------+-------------+
| ####           | Prepare caDSR presentation           | ####        |
|  Brenda/Janice |                                      |  03/14/2007 |
+----------------+--------------------------------------+-------------+
| #### Quan      | Arrange for VCDE presentation        | ####        |
|                |                                      |  03/14/2007 |
+----------------+--------------------------------------+-------------+

**Attendees**

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

  Rhonda            Arzoonanian        University of WI

  Jaswant           Bhorjee            National Cancer

  Troy              Budd               DCP

  Dawn              Caron              MSKCC

  Quan              Chen               Albert Einstein College of
                                       Medicine

  Janice            Chilli             SAIC

  Lara              Fournier           OHSU

  Jenny             Kelley             NCI

  Connie            Kiefer             CTIS

  Bob               Lanese             Case

  Brenda            Maeske             SAIC

  Rick              Magnan             ECOG

  Bob               Morrell            Wake Forest

  Sorena            Nadaf              Vanderbilt University

  Joyce             Niland             City of Hope

  Susan             Pannoni            City of Hope

  George            Redmond            CTEP

  Karen             Ryan               Booz Allen Hamilton

  Vicki             Sallee             University of PA

  Daniela           Smith              Booz Allen Hamilton

  Stephine          Wasielewski        University of Wisconsin

  Pat               Winkler            NCI
  ----------------- ------------------ ----------------------------------

**Meeting Notes**

**1. Review Minutes: 02/14/2007 Conf Calls**

The minutes from Feb 14th were approved.

-   **Action Items:** \*Post approved minutes to gForge \*Finish draft
    minutes from today\'s meeting.

**2. Presentation on ECOG developed CDE Search Tool (Magnan)**

Rick opened with presentation of CDE Search tool that ECOG developed
several years ago (2004) for a user base of 2-3 users.

He discovered, as he started to dig into this, that the folks this tool
was developed for were no longer using it. This was likely due to
upgrades in caDSR and the search tool wasn't updated accordingly - some
functionality was lost and it was too slow and they found it easier to
just NCICB\'s developer CDE Browser.

He mentioned, if folks are interested, they do have the source code and
are willing to share it. You\'d need a fairly capable Java, XSLT
programming to take it over. There is a 30 page tech document if anyone
wants to breathe new life into this.

He mentioned one of the advantages that their tool had was the ability
to string together searches with ANDs, ORs and NOT. You could also
search the global library in your own CTMS system as well.

Brenda clarified with the recent upgrade of caDSR Browser (3.2 build 7)
that it is enhanced so you can filter on the status of standard; You can
also search on exact phrase or some of the words and can search
permissible values. They have tried to develop to user requirements.

Bob L. asked a general question about caDSR...browsing right now, if he
typed in \"Race\" it returns 7 matches. His question was which one
should you use and why? Brenda answered that you usually you pick the
CDE with a registration status as \'Standard\'. She also mentioned that
you can check the checkbox next to the CDE, click the \"Compare CDEs\"
option and this allows you to see exactly what the differences are.
Janice mentioned that sometimes, there are multiple \"Released\" CDEs
with multiple areas that have the same type of data. This is when we
start to harmonize.

Bob then added that in the case of NCI/NIH, they have published very
explicit documentation of what they want. He mentioned that it be of
value to put in a notation somewhere that indicates that this is what is
used by NCI or NIH? Right now - nothing jumps out at me that says -
\"this is what the NCI is using\"

Janice mentioned that we should refer to spreadsheet we presented in the
fall. Make sure that we had CDEs out there each of the fields used in
these reports. The end result of this will be that we can add a notation
in this CDE to indicate that it is tied to this specific report. The CDE
would capture the specific value, both it's size and data type for this
report field. Each of the data fields and it's associated CDE is owned
by a context (caBIG, CTEP, DCP, etc.) For the reports we have identified
like Summary 4, caBIG/CTMS would be the owner of this CDE. If another
context group would reuse this CDE because they also had a need to
represent the same data and value, then they would be listed under the
"Used By" column in the able results. When multiple groups are using the
same CDE, it becomes a candidate for harmonization and a potential
standard within the caBIG community, The spreadsheet was started last
Fall (Oct) by Bev and Troy and presented to this group to show one
method of collecting everyone\'s way of representing the same data field
in one place which would allow this group to then review and harmonize
the data field, then promote it to the caBIG community as a standard. On
the spreadsheet presented in the fall, there were a number of fields
that did not associate a CDE to the report field; now is the perfect
time to start and identify these and get them added in the format that
we are using them in the reports.

Someone asked about CDASH? They explained that it is supported by CDISC
and sponsored by FDA and they are trying to develop standardized CRFs.
Would love to find out what they use when they develop their common data
elements for their case report forms.

Someone added that they\'ve heard the CTDB and CRF SIGs were created but
have heard nothing else on the matter. CDASH seems to be something we
should be involved with.

The SIG meetings were on hold pending the formation and kickoff of the
CTMS Steering committee. Another added that they believe the CDASH
effort is harmonizing and using the Data Elements in EVS and caDSR. They
will be contributing CRF samples and harmonizing the best elements of
these.

-   **Action Items:** \*Plan for presentation on caDSR next meeting.

**3. Revisit Parts of Competing CCSG related to but not Summary ¾
(Morrell)**

Bob Morrell then discussed the other summaries (count of 5) and reports
from CCSG (not Summary 3 & 4) and brought examples of 4 of them.

He mentioned the [Race/Ethnicity]{.underline} totals and regarding race,
the NIH guidelines say that a patient can circle as many they want. If a
large proportion of these were multiple races, then you can (at your
discretion) supply this additional information. He added the total
numbers here come straight out of summary 4 and should agree with the
caveat that they should be local accrual. These numbers have to match to
your accrual data. If you try to break out the multiple race entries,
then they will no longer match. They are supposed to match up with the
patient population that your local area serves.

He asked about who owns this form used to tally the race ethnicity
totals and can we go back to them and ask them to update? Someone
answered that it does come from OMB standard.

He then discussed the [Protocol Specific Research]{.underline} section
of grant. Here you list number of protocols and accrual numbers. This
creates an issue if a patient is on mixed phase trial and how do you
count them.

He also mentioned the [Summary of Clinical Research
Accrual]{.underline}. These are all groupings straight out of summary 4.
The new much focused definition of Therapeutic breaks down into separate
categories. The differences between Ancillary, Companion and Correlative
are not very well defined. Other difficulties he\'s dealt with are that
some of these categories didn\'t exist 5 years ago and they have been
faced with reclassifying old studies long forgotten about. This will
also cause totals not to match from previous submissions which may cause
some concern. Janice mentioned that it is possible to capture specific
lists of values in a CDE. She offered to create a CDE for an example
that Bob will send to the group and present it at the next meeting. The
process is to review and reach consensus in the group as to the meaning
of these values that are being used, and then document it into a CDE and
potential move it forward as a standard within the community.

For the [Shared Resources]{.underline} section, we break down as many
things that we can capture out of our system and we throw it in there.
Joyce added that we capture hours and accruals (patients in follow up).

Regarding the [Protocol Review and Monitoring System]{.underline}
section (PRMS).

He mentioned that this caused us a lot of trouble and we also realized
that we did it wrong. Many folks go through minutes in meeting and
simply count this up. We now have it programmed into our CTMS. What we
missed was the very last line (# monitored for progress and
performance??). We didn\'t have definitions for these. Some people
disagree with what \'activated\' means\...Other thing that caused us
trouble. Our IRB stretches out the timeframe (sometime as much as a
year)...there\'s such a lag time that our site reviewers had trouble
connecting what was actually going on. A lot of these trials that just
went through the PRC committee (and no further)...never did get defined.

**4. Next Conference Call Scheduled on Wednesday, March 14th**

There will possibly be a couple of presentations for the next meeting
(VCDE and caDSR). Rhoda asked that folks in charge of this please
confirm with her whether this will work.