[NCI Trial Complexity Elements & Scoring Model]{.underline}

January, 2009

Background Information

The Clinical Trials Working Group's (CTWG) Operational Efficiency
Initiative included a recommendation to align reimbursement with trial
complexity as one component proposed for an improved funding model. The
goal in creating the criteria for a trial complexity model was to
develop a simple, standardized model listing a representative number of
trial elements deemed to involve increased effort at the participating
sites. These elements are not designed to describe every detail of a
trial, but were selected as those most likely to identify the most
time-consuming and complex work for accruing sites. The impact of trial
complexity on the Cooperative Group, CTEP or additional sponsor or
collaborator is not included in this model as the focus is on the work
at the participating site. Each element was divided into three
categories- standard, moderate, high- based on its level of complexity.
A working group was assembled with representation from each Cooperative
Group and NCI staff to develop this model and input on this final draft
model was further gained from cancer center staff and CCOP research
nurses, CRAs, and investigators. Studies deemed "complex" based on the
10 elements described in the complexity model may be eligible to receive
additional funds- when available- beyond the base capitation. As this is
a new model, it will be reevaluated in 2009. The Trial Complexity
Working Group is open to suggestions to improve the trial element
descriptions, rating criteria, or other suggestions for improvement.
Please e-mail any suggestions to the Chair of the Trial Complexity
Working Group, Andrea Denicoff, at <denicofa@mail.nih.gov> .

### The Trial Elements

### Element \# 1: Number of Study Arms

###### Tiers for the Number of Study Arms

Level 1 (standard): 1-2 study arms

Level 2 (moderate): 3-4 study arms

Level 3 (high) : \>4 study arms

### Element \# 2: Informed Consent Process

###### Discussion

This element will be assessed by estimating the extent of effort it
would take to describe a study to a patient. Molecular markers or
targeted therapies tend to make the consenting process more difficult.
Consent length was not included below due to the simple fact that length
does not always correlate with complexity. However, in order to capture
the increased effort required of the site to provide an adequate
informed consent process, the complexity of the randomization/
registration process will be incorporated into the levels below as well
as considered as a sole category. The issue of translation of the
informed consent process into other languages is addressed in Element
#10 on Participant Enrollment issues.

###### Tiers for the Informed Consent Process

Level 1 (standard)

-   Straightforward

-   Standard of care vs. investigational treatment

-   One step registration/ randomization

Level 2 (moderate)

-   Simple trials with placebo arms

-   Trials containing arms that, while ethical, may be difficult for
    patients to accept

-   Observation only study arms

    -   Studies involving separate registration and randomizations (2
        steps)

    -   Trials requiring assent process for the participants

Level 3 (high)

-   Highly complex study to describe to patients

    -   Predictive molecular markers for patient assignment

    -   Mandatory crossover arms

    -   Regulatory mandated additional informed consent requirements,
        such as when the FDA requires that a separate document be signed
        for patients receiving thalidomide which has extensive
        requirements for birth control measures and routine periodic
        requirements pregnancy tests

-   Studies involving multiple steps/ randomizations

-   Studies involving intraoperative randomization

-   Examples: E5202, TailoRx, E1A06

### Element \# 3: Registration or Randomization Steps

###### Discussion

###### This element will be assessed on behalf of the site- simply the effects of the study design on the site. However, due to its effects on the consenting process, the complexity of the randomization/ registration process will also be incorporated into the informed consent element. 

###### Tiers for Complicated Randomizations

Level 1 (standard)

-   Only one registration or randomization step

-   Example: CALGB-40101

Level 2 (moderate)

-   Registration & randomization occurs in separate steps

-   Central Pathology Review (less involved than below)

-   Examples: NSABP B42, TailoRx

Level 3 (high)

-   Multiple steps/ randomizations

-   Intraoperative randomizations

-   Complex central pathology review (ie. tumor genotyping) prior to
    randomization

-   Examples: E2906, E5202, ACOSOG Z4032

Element \# 4: Complexity of Investigational Treatment

###### Discussion

Complexity of treatment will incorporate: inpatient vs. outpatient
treatment, oral agents vs. IV bolus vs. continuous infusions, and/or
single or multi-modality. In addition, length of treatment may also be
considered. The more toxicities associated with an investigational
treatment, the higher the complexity and the higher the associated
workload or staff time required. Comments included whether or not the
following items should be included below: approved or investigational
agent status, requirement for central radiologic review, and/or the
amount of support from pharmaceutical companies. Although investigator/
site credentialing also impacts Element #6, it is included below as
credentialing has been typically linked with treatment (as evidenced by
some radiation and surgical trials).

*Tiers for Complexity of Treatment*

Level 1 (standard)

-   Outpatient; single modality therapy

-   Similar to the standard of care for the studied disease

Level 2 (moderate)

-   Combined modality therapy

    -   radiation and chemotherapy

    -   interval debulking surgery

    -   conventional chemotherapy and biologics

-   Simple inpatient treatments

Level 3 (high)

-   Investigational treatments with a high potential for multiple
    toxicities to monitor, report and manage, such as:

    -   Investigational bone marrow/stem cell transplant

    -   Gene transfer studies and complex vaccine trials

    -   Treatment studies in acute leukemia, CNS lymphoma, lymphoblastic
        lymphoma

-   Investigator/site credentialing required before study activates

-   Example: E2906, E1805

### Element \# 5: Length of Investigational Treatment

###### Discussion

Cycle length as a possible criterion was considered; however, as it
varies so drastically, it was not incorporated. As this category is so
difficult to quantify, examples of particular protocols will be
critical.

###### Tiers for Length of Investigational Treatment

Level 1 (standard)

-   Regimens with a defined number of cycles

-   Routine or standard hormonal therapy (ie. 5 yrs. of tamoxifen or AI
    for breast cancer)

Level 2 (moderate)

-   Lengthy study with treatment until progression (not a defined
    number)

-   Long period of hormonal therapy or standard agent maintenance
    therapy, in addition to administration of the investigational agent

Level 3 (high)

-   Extended administration of investigational treatment by sites, such
    as longer than 6 months. Examples include: maintenance therapy and
    trials that include bevazicumab infusions or IV placebo q21 days
    from cycles 7 through 22 (i.e. GOG-0218)

### Element \# 6: Feasibility & Personnel Impact 

*Discussion*

This category addresses impacted personnel (ie. pharmacists,
radiologists, cardiologists, pathologists, translational scientists,
bioinformatics experts, etc.) whom would not be incorporated into the
elements previously discussed. In order to help quantify this category,
the more disciplines needed to coordinate and implement multi-modality
trials, the more complex trial management becomes for sites. In
addition, trials that require sites to engage personnel in disciplines
that previously or typically did not participate in "standard" Group
clinical trials may be scored as high complexity. Although not
incorporated into the criterion below, the need for additional training,
software, equipment, etc. should also be considered upon assignment of
the appropriate level.

*Tiers for Feasibility & Personnel Impact*

Level 1 (standard)

-   Involves only the typical clinical research team

-   Only 1 discipline

Level 2 (moderate)

-   Involves a moderate number of different medical disciplines/ staff

-   Examples: NSABP B35; NSABP B39; RTOG 0232

Level 3 (high)

-   Involves a high number of different medical disciplines/ staff and
    requires more involved effort and quantities of their time to
    coordinate, for example: NSABP- B-40 requires consenting followed by
    an additional (nonstandard) collection of 4 core biopsies. This
    requires coordination with surgeons, oncologists, pathologists,
    radiologists and radiation oncologists prior to eligibility
    confirmation and patient registration

-   Involves \>2 disciplines

-   Engaging a new discipline to work in a disease trial, whereby
    requiring complex coordination among disciplines.

### 

### Element \# 7: Data Collection Complexity

*Discussion*

As a protocol becomes more complicated, so does the data collection
process. The WG encouraged justification of scores, especially if groups
considered additional factors when scoring (i.e. complex regulatory
submissions, etc).

*Tiers for Data Collection Complexity*

Level 1 (standard)

-   Standard adverse event reporting

-   Prospective submission of usual/ standard regulatory data

-   Adjuvant study with standard group CRF collection packet

Level 2 (moderate)

-   Specific adverse events reported in an expedited manner (above and
    beyond normal)

-   Retrospective collection of additional regulatory data

-   Prospective submission of a larger than normal amount of regulatory
    data (i.e. laboratory normals, documentation associated with
    international trials, etc.)

-   Additional data collection, such as concomitant medication

-   RECIST criteria

-   Multiple step study

-   Example: S0533

Level 3 (high)

-   Real time reporting of adverse events above and beyond the toxicity
    reporting required for AdEERS

-   Real time data submission

-   Increased data collection requirements for a trial under a SPA or
    registration trial

-   Complex hematologic study

-   Collection (retrospective or prospective) of scans for endpoint
    review

-   Central review of imaging dictates treatment decisions

-   Examples: S0016, S0528

### 

### Element \# 8: Follow-up Requirements

###### Discussion

The tiers below were mapped to the Tier Reimbursement System for
Ancillary Funds. See
<http://ctep.cancer.gov/protocolDevelopment/docs/tier_ancillary_studies.pdf>
. Length of time may also be taken into consideration; however, concerns
were noted regarding the common discrepancy among actual vs. requested
patient follow-up (due to toxicity, SAEs, etc.).

###### 

###### Tiers for Follow-up Requirements

Level 1 (standard)

-   Ancillary Tiers for Payments for Follow-Up Data Collection: Tier 1

-   Up to 2 years of follow-up requirements

Level 2 (moderate)

-   Ancillary Tiers for Payments for Follow-Up Data Collection: Tier 2

-   2-5 years of follow-up requirements

Level 3 (high)

-   Ancillary Tiers for Payments for Follow-Up Data Collection: Tier 3

-   \>5 years of follow-up requirements

-   Protocols requiring sites to continue collecting further treatment
    and toxicity information even after a patient is taken off study due
    to disease progression. (i.e. one Group sometimes asks for further
    treatment and toxicity information pertaining to any new
    non-protocol treatment)

### Element \# 9A & B: Ancillary Studies 

###### Discussion

Although funded via the Ancillary Studies mechanism, ancillary studies
are included in the complexity tier model due to the increased work
imparted to the site to coordinate these additional requirements. To
simplify matters, the two different categories of the ancillary studies
elements- elements 9A (Correlative Science/ Imaging) and B (QOL/ Cancer
Control/ Health Services)- are based on the Ancillary Studies Tiers
\[see
<http://ctep.cancer.gov/protocolDevelopment/docs/tier_ancillary_studies.pdf>\].
A protocol that has both types of ancillary studies has the potential to
score up to 4 points for trial complexity (0-2 for Part A; 0-2 for Part
B). Only mandatory correlative science proposals should factor into the
scoring of this element. The WG encouraged justification of scores
especially if groups considered additional factors when scoring (i.e.
the sheer number of correlatives, etc.).

###### Tiers for Ancillary Studies

Level 1 (standard)

-   No ancillary studies

-   Ancillary Tiers for Correlative Science/ Imaging: Tier 1

-   Ancillary Tiers for HRQOL, Cancer Control, Health Services, & other
    Ancillary Studies: Tier 1

-   Example: S0622

Level 2 (moderate)

-   Ancillary Tiers for Correlative Science/ Imaging: Tier 2, Tier 3 I &
    II

-   Ancillary Tiers for HRQOL, Cancer Control, Health Services, & other
    Ancillary Studies: Tiers 2 & 3

Level 3 (high)

-   Ancillary Tiers for Correlative Science/ Imaging: Tier 3III & 4

-   Ancillary Tiers for HRQOL, Cancer Control, Health Services, & other
    Ancillary Studies: Tier 4

-   Examples: S0106

**Element \# 10: Participant Feasibility & Enrollment**

*Discussion*

For this element, the level of complexity will correspond to the
difficulty in trial participant identification; highly selective
eligibility criteria leading to high "screening-failure" rates; or the
scarcity of trial population (uncommon tumor types) , the higher the
level of complexity. Due to the subjectivity of this element,
justification will be required for an assignment of "moderate" or
"high".

###### Tiers for Participant Feasibility & Enrollment

Level 1 (standard):

-   Target population is in a cancer diagnoses routinely seen by most
    sites

Level 2 (moderate):

-   Trial population is in an uncommon cancer diagnosis and requires
    sites to do outreach to other disciplines for referrals

-   Target population is a common cancer not usually considered for
    clinical trials

-   Trial has highly selective eligibility criteria with regards to
    molecular screening. Anticipated screen failures common (ie.
    C80405).

Level 3 (high):

-   Target population includes underrepresented groups (i.e. Minority,
    elderly, etc.) that may require sites to increase their time
    commitment to recruitment. May include extra efforts to design low
    literacy level consent forms and consent forms in multiple
    languages.

### 

### Cooperative Group Comments

Although the Trial Complexity Tier Development WG defined criterion for
the above 10 elements, the cooperative groups are encouraged to suggest
modifications/ additions/ etc. to the scoring system. If groups score
elements based on relevant- albeit not currently incorporated-
criterion, then a written explanation will be required. On an annual
basis, the WG will review the system and implement any necessary
changes.

### 

### Overall Complexity Score

For each element above, the following scoring schematic applies: 0
points for standard, 1 point for moderate, and 2 points for high. Once
the ten elements are defined, their associated scores can be totaled.
The WG considered assigning a trial an ultimate rating of "Standard",
"Moderate", or "High" complexity based on this final score. Due to the
uncertain connotation of such a label, the WG members were wary of
establishing this guideline. The WG will review the elements and scoring
of trials after 6-12 months of use and plan to assess the needs for
revisions after experience with this model. If changes are deemed
necessary to improve the model, the WG will circulate changes for
comment and present recommendations for possible changes at future
Cooperative Group Chairs meetings

**Trial Complexity Elements & Scoring -- Quick Chart View**

+-------+--------------+--------------+--------------+---------------+
| **El  | **Study      | **Standard   | **Moderate   | **High (2     |
| ement | Element**    | (0           | (1           | points\*)**   |
| \#**  |              | points\*)**  | point\*)**   |               |
+-------+--------------+--------------+--------------+---------------+
| **1** | Study Arms   | 1 or 2 study | 3 or 4 study | \>4 study     |
|       |              | arms         | arms         | arms          |
+-------+--------------+--------------+--------------+---------------+
| **2** | Informed     | -Str         | -Simple      | -Highly       |
|       | Consent      | aightforward | trials with  | complex study |
|       | Process      |              | a placebo    | to describe   |
|       |              | -One step    |              | to patients   |
|       |              | ra           | -Trials with |               |
|       |              | ndomization/ | arms a bit   | -Studies      |
|       |              | registration | more         | involving     |
|       |              |              | difficult    | multiple      |
|       |              |              | than         | steps/        |
|       |              |              | standard     | r             |
|       |              |              |              | andomizations |
|       |              |              | -Studies     | or            |
|       |              |              | with a 2     | i             |
|       |              |              | step         | ntraoperative |
|       |              |              | r            | randomization |
|       |              |              | egistration/ |               |
|       |              |              | r            |               |
|       |              |              | andomization |               |
|       |              |              | process      |               |
+-------+--------------+--------------+--------------+---------------+
| **3** | Registration | One step     | -Separate    | -Multiple     |
|       | or           |              | r            | steps/        |
|       | Ra           |              | egistration/ | r             |
|       | ndomizations |              | ra           | andomizations |
|       | Steps        |              | ndomizations |               |
|       |              |              |              | -I            |
|       |              |              | -Central     | ntraoperative |
|       |              |              | Pathology    | r             |
|       |              |              | Review (less | andomizations |
|       |              |              | involved)    |               |
|       |              |              |              | -Complex      |
|       |              |              |              | Central       |
|       |              |              |              | Pathology     |
|       |              |              |              | Review prior  |
|       |              |              |              | to            |
|       |              |              |              | randomization |
+-------+--------------+--------------+--------------+---------------+
| **4** | Complexity   | Outpatient   | -Combined    | \- Treatments |
|       | of           | single       | modality     | with          |
|       | Inv          | modality     | treatments   | potential for |
|       | estigational |              |              | increased     |
|       | Treatment    |              | -Simple      | toxicity      |
|       |              |              | inpatient    | (i.e. gene    |
|       |              |              | treatment    | transfer,     |
|       |              |              |              | in            |
|       |              |              |              | vestigational |
|       |              |              |              | bone marrow/  |
|       |              |              |              | stem cell     |
|       |              |              |              | transplant,   |
|       |              |              |              | etc.)         |
|       |              |              |              |               |
|       |              |              |              | -             |
|       |              |              |              | Investigator/ |
|       |              |              |              | site          |
|       |              |              |              | credentialing |
|       |              |              |              | required      |
+-------+--------------+--------------+--------------+---------------+
| **5** | Length of    | -Regimens    | -Cycles of   | -Extended     |
|       | Inv          | with a       | treatment    | a             |
|       | estigational | defined \#   | are not      | dministration |
|       | Treatment    | of cycles    | defined      | of            |
|       | (tx)         |              |              | in            |
|       |              | -Routine or  | -Long period | vestigational |
|       |              | standard     | of hormonal  | rx            |
|       |              | hormonal     | or standard  |               |
|       |              | therapy      | maintenance  |               |
|       |              | (i.e. 5 yrs. | therapy, in  |               |
|       |              | of tamoxifen | addition to  |               |
|       |              | or AI for    | inv          |               |
|       |              | breast       | estigational |               |
|       |              | cancer)      | agents       |               |
+-------+--------------+--------------+--------------+---------------+
| **6** | Feasibility  | -1           | \- Moderate  | \- High       |
|       | & Personnel  | discipline   | number of    | number of     |
|       | Impact       |              | medical      | medical       |
|       |              | -Standard    | disci        | disc          |
|       |              | clinical     | plines/staff | iplines/staff |
|       |              | research     | involved     | involved      |
|       |              | team         |              |               |
|       |              |              |              | -Involves     |
|       |              |              |              | complex       |
|       |              |              |              | coordination  |
|       |              |              |              | among         |
|       |              |              |              | disciplines   |
+-------+--------------+--------------+--------------+---------------+

+-------+--------------+------------+---------------+----------------+
| **El  | **Study      | **Standard | **Moderate (1 | **High (2      |
| ement | Element**    | (0         | point\*)**    | points\*)**    |
| \#**  |              | p          |               |                |
|       |              | oints\*)** |               |                |
+-------+--------------+------------+---------------+----------------+
| **7** | Data         | -Standard  | -Expedited AE | -Real time AE  |
|       | Collection   | AE         | reporting     | reporting      |
|       | Complexity   | reporting  |               | above and      |
|       |              |            | -             | beyond that    |
|       |              | -P         | Retrospective | required for   |
|       |              | rospective | submission of | AdEERs         |
|       |              | submission | regulatory    |                |
|       |              | of usual/  | data          | -Collection of |
|       |              | standard   |               | scans for      |
|       |              | regulatory | -Prospective  | endpoint       |
|       |              | data       | submission of | review         |
|       |              |            | a larger than |                |
|       |              | -Adjuvant  | normal amount | -Central       |
|       |              | study with | of regulatory | review of      |
|       |              | standard   | data          | imaging        |
|       |              | Group CRF  |               | dictates       |
|       |              | collection | -Additional   | treatment      |
|       |              | packet     | data          | decisions      |
|       |              |            | collection    |                |
|       |              |            | (e.g. Conmed  | -Increased     |
|       |              |            | CRF)          | data           |
|       |              |            |               | collection     |
|       |              |            |               | requirements   |
+-------+--------------+------------+---------------+----------------+
| **8** | Follow-up    | -Ancillary | -Ancillary    | -Ancillary     |
|       | Requ         | Tiers for  | Tiers for     | Tiers for      |
|       | irements\*\* | Follow-Up  | Follow-Up     | Follow-Up Data |
|       |              | Data       | Data          | Collection     |
|       | (see link    | Collection | Collection    | (Tier 3)       |
|       | below)       | (Tier 1)   | (Tier 2)      |                |
|       |              |            |               | -\>5 yrs. of   |
|       |              | -Up to 2   | -2-5 yrs. of  | follow-up      |
|       |              | yrs. of    | follow-up     |                |
|       |              | follow-up  |               |                |
+-------+--------------+------------+---------------+----------------+
| **9   | Ancillary    | -Ancillary | -Ancillary    | -Ancillary     |
| A&B** | Studies      | Tiers for  | Tiers for CS/ | Tiers for CS/  |
|       | A\*\*        | CS/        | Imaging (Tier | Imaging (Tier  |
| **(   |              | Imaging    | 2, Tier 3 I & | 3 III & 4)     |
| score | Includes     | (Tier 1)   | II)           |                |
| A:    | correlative  |            |               |                |
| 0-2   | science,     |            |               |                |
| and   | imaging      |            |               |                |
| B:    | studies      |            |               |                |
| 0     |              |            |               |                |
| -2)** |              |            |               |                |
| (see  |              |            |               |                |
| link  |              |            |               |                |
| b     |              |            |               |                |
| elow) |              |            |               |                |
+-------+--------------+------------+---------------+----------------+
|       | Ancillary    | -Ancillary | -Ancillary    | -Ancillary     |
|       | Studies      | Tiers for  | Tiers for     | Tiers for QOL, |
|       | B\*\*        | QOL, CC,   | QOL, CC, etc. | CC, etc. (Tier |
|       |              | etc. (Tier | (Tiers 2 & 3) | 4)             |
|       | Includes     | 1)         |               |                |
|       | QOL,         |            |               |                |
+-------+--------------+------------+---------------+----------------+
| *     | Participant  | -Target    | \- Target     | \- Target      |
| *10** | Feasibility  | population | population is | population     |
|       | and          | routinely  | an uncommon   | includes       |
|       | Enrollment   | seen by    | cancer        | und            |
|       |              | most sites |               | errepresented, |
|       |              |            | -Target       | such as        |
|       |              |            | population is | elderly &      |
|       |              |            | a common      | minority       |
|       |              |            | cancer not    | groups;        |
|       |              |            | usually       | specialized    |
|       |              |            | considered    | recruitment    |
|       |              |            | for trials    | efforts will   |
|       |              |            |               | be required    |
|       |              |            | \- Trial has  |                |
|       |              |            | highly        | \*\            |
|       |              |            | selective     | *Justification |
|       |              |            | eligibility   | required       |
|       |              |            | criteria with |                |
|       |              |            | regards to    |                |
|       |              |            | molecular     |                |
|       |              |            | screening     |                |
|       |              |            |               |                |
|       |              |            | \*\*          |                |
|       |              |            | Justification |                |
|       |              |            | required      |                |
+-------+--------------+------------+---------------+----------------+

\*\*For the Ancillary Studies, please see this link:
[[http://ctep.cancer.gov/protocolDevelopment/docs/tier_ancillary_studies.pdf]{.underline}](http://ctep.cancer.gov/protocolDevelopment/docs/tier_ancillary_studies.pdf)

\*\*Scoring:

-   Give each element a score of 0, 1, or 2

-   Element #9 may contribute 2 sets of complexity scores if a trial has
    the 2 different categories of ancillary studies based on the
    Ancillary Studies Tiers\*\* referred to in this chart as Element 9,
    Part A (Correlative Science/Lab/Imaging) and Element 9 Part B (QOL,
    Cancer Control (CC) or Health Services Research). Therefore, a
    protocol that has both types of ancillary studies, correlative
    science and QOL, has the potential to score up to 4 points (0-2 for
    correlative and 0-2 for QOL).

-   Sum the scores of all elements for a total complexity score and use
    the total scores to compare and rate trial complexity

**Trial Complexity Tier WG Members**

  ------------------------------------- ---------------------------------
  Name                                  Cooperative Group

  Beth Martinez                         ACOSOG

  Kathy Karas                           CALGB

  Mary Sherrell                         CALGB

  Maura O'Leary                         COG

  Martha Herring                        CTSU

  Karen Kolbe                           CTSU

  Ruth Lambersky                        CTSU

  Donna Marinucci                       CTSU

  Steve Riordan                         CTSU

  Mary Steele                           ECOG

  Deb Strandberg                        ECOG

  Larry Copeland                        GOG

  Kia Neff                              GOG

  Laura Reese                           GOG

  Mary Sharp                            GOG

  Betty Stonebraker                     GOG

  Aimee Fjelstad                        NCCTG

  Desirae Sagdalen                      NCCTG

  Belinda Vandersluis                   NCIC

  Walt Cronin                           NSABP

  Barbara Harkins                       NSABP

  Donna Szczepankowski                  NSABP

  Tom Wudarski                          RTOG

  Abbie Brown                           SWOG

  Nathan Eriksen                        SWOG

  Marj Godfrey                          SWOG

  Joy Reilly                            SWOG

  Anne Schott                           SWOG

  Zoe Vanella                           SWOG

  Robyn Burns                           NCI/ EMMES

  Andrea Denicoff                       NCI

  Shanda Finnigan                       NCI

  Steve Friedman                        NCI

  LeeAnn Jensen                         NCI

  Elise Kreiss                          NCI

  Jean Lynn                             NCI

  Joan Mauer                            NCI

  Lori Minasian                         NCI

  Gary Smith                            NCI

  Cynthia Whitman                       NCI
  ------------------------------------- ---------------------------------