#### Teleconference Information

####  What: AE SIG

Date: April 26, 2007

SIG Lead: Joyce Niland, Ph.D.

Minutes: Susan Pannoni

#### Meeting Materials:

####  AE SIG Minutes 20070412.doc

#### Executive Summary: The caAERS F2F will occur May 3-4. Teleconference information will be distributed to the AE SIG members and all are welcome to participate. There was some discussion related to the vocabulary for capture of adverse events and disease. Since MedDRA cannot be part of caAERS due to licensing considerations, there will be a mechanism for it to be loaded upon installation.

#### Jennifer Neat provided a demonstration of the new features in the CALAEGS Alpha Release 3.0, now available for testing. Development is continuing with the next releases providing functionality to enable upload of lab data in formats other than the currently specified CSV.

#### Action Items

+----------------+--------------------------------------+-------------+
| ##             | #### Description                     | ##          |
| ## Assigned To |                                      | ## Due Date |
+----------------+--------------------------------------+-------------+
| Susan Pannoni  | Prepare Minutes                      | 05/09/2007  |
+----------------+--------------------------------------+-------------+

#### 

#### Next Steps:

#### We will continue to review caAERS application development progress and receive updates on the CALAEGS project.

#### Attendees

  ------------------------------------ ----------------------------------
  **Attendee Name**                    **Affiliation/Email**

  Ann Setser                           NCI - CTEP

  Brenda Maeske                        SAIC

  Cal Collins                          Akaza Research

  Christo Andonyadis                   NCICB

  Daniela Smith                        BAH

  Diane Paul                           Patient Advocate

  Edmond Mulaire                       SemanticBits, Inc.

  Eva Hoke                             CALGB

  Jennifer Neat                        City of Hope

  Joyce Niland                         City of Hope

  Kim Livengood                        Wake Forest

  Lynne Wilkens                        University of Hawaii

  Sean Whitaker                        Northwestern

  Sonja Hamilton                       Mayo Clinic

  Susan Pannoni                        COH
  ------------------------------------ ----------------------------------

#### Meeting Notes:

1.  Review/approval of SIG minutes from 04/12/07\
    A change was made to the previous minutes to complete the sentence
    in which Edmond had mentioned that the caAERS team was 'working with
    DCP' to understand their reporting requirements and get input. The
    minutes were approved with this change.

2.  caAERS Update (Edmond Mulaire)

    Edmond reminded everyone about the upcoming caAERS F2F.\
    \
    Sean mentioned that we can't legally distribute MedDRA to users (as
    part of caAERS). However, the anticipated users of caAERS would have
    the ability to use it , so a mechanism would be provided in caAERS
    for users to load MedDRA in so that it can be used. When a user sets
    up a study, they will also be able to select which vocabulary (from
    those available) will be used. With respect to disease, a vocabulary
    would also be defined. CTEP-sponsored trials always use the CTEP
    disease list.

    Ann noted that for AEs, they are currently in the process of
    revising the CTC and that the next version will be more MedDRA-like,
    although there are just 2 levels in MedDRA and we may require more.
    Currently, the process for revisions is being determined and then
    will work on the grading scales. This will probably not be ready for
    implementation until July 2008 (based on current schedule).

    Someone noted that some Coop Groups actually record MedDRA code with
    CTC term. Displaying the MedDRA term in caAERS is a good idea. If
    'other specify' is used, it would be nice to see if a MedDRA term is
    available rather than utilizing free text (to ensure some
    consistency). The system must handle non-CTEP trials so using MedDRA
    (common in 'oncology world') is necessary.

    When MedDRA is revised, the new version includes additions, inactive
    terms and modifications. Pharma used to stay with a version of
    MedDRA that was 'active' at the time the trial was opened. Now they
    move to the most current version of MedDRA when it is released.
    Similarly, when CTCAE 3.0 was introduced, institutions were able to
    use CTC 2.0 but mapped to the current MedDRA. Many institutions and
    Coop Groups, however, chose to move to CTCAE 3.0 so they didn't have
    to manage both versions.

    Ann mentioned that an update is made to MedDRA about every 6 months.
    However, industry and CTEP only update with major releases. We need
    to also raise this with DCP.

    It was noted again that the data collection mechanism in caAERS
    currently is very report-centric. The application must be able to
    handle all Adverse Events (not just those on reports) as well as
    solicited AEs. The caAERS team acknowledged that this was the plan.

3.  CALAEGS Update (Jennifer Neat)

    Jennifer provided an update on the CALAEGS project. Alpha Release
    3.0 was just made available. The new features include:

    -   Expanded trials to include Blood/Bone Marrow and Coagulation
        labs and Cardiac Troponin T. Urine Protein (dipstick) was also
        added.

    -   Additional units of measure were supported for most of the labs
        and standard conversions (for instance from g/dL to g/L) were
        implemented

    -   Implemented functionality to enable use of inequalities in
        reference ranges and lab values.

    -   Notations provided in cases where lab normal ranges overlap with
        the grading criteria, sometimes providing a grade acknowledging
        the institutional 'normal range' and a second grade based solely
        on the CTC grading criteria.

        The enhancements listed (above) were implemented for both the
        grading calculator (manual entry) and the fixed format CSV file
        upload.

        In response to a question from Christo, Jennifer noted that
        CALAEGS is currently handling the labs that can be
        quantitatively assessed. We are currently working at COH on
        workflow for the qualitative area but this is not currently
        planned to be part of CALAEGS. When data is imported from a lab,
        it will contain labs that can not be evaluated by CALAEGS; these
        will be returned as 'unassessable'.

        Ann asked about the calcium lab because the corrected calcium
        may be needed to make a full AE assessment. Jennifer mentioned
        that assessments requiring more than one lab such as corrected
        calcium were scheduled in release 4.0.

        Jennifer demonstrated how a lab may provide data in g/L whereas
        the CTC grading scale is based on g/dL. A conversion factor is
        used and is displayed in the calculator. She noted that we do
        not display the converted values (reference range and lab value)
        that are actually used 'behind the scenes'; we just show the
        grade and notes. She also demonstrated an entry with an
        inequality (reference range is \< n ).

        When the institutional reference range overlaps with the grading
        criteria, most overlaps will return 2 grades -- one indicating
        that considering the reference range it might be a grade 0 while
        solely based on the CTC grading criteria, it would be a grade 1.
        Currently, when the lab value is on the grade 1 boundary, we are
        only returning the grade based on the grading criteria as this
        needs more discussion. Ann commended the team on the level of
        scrutiny in developing the application.

        Diane asked if the information from CALAEGS would make it into
        the electronic patient record. Yes, the intention is for this
        information to be available in electronic format for integration
        into a local CTMS, EMR, and/or a reporting system such as
        caAERS.