# ![](media/image1.png){width="1.75in" height="0.6965277777777777in"}NCI caBIG® \| Meeting Notes 

## Topic: Kickoff Meeting 

Date: 30 July 08

Location: NIH - 2115 East Jefferson Street, Room 5034

Attendees: Lisa Mahoney, Kenyon Ericson, Malcolm James, Libby Prince,
John Koisch, Charlie Mead, Wendy Patterson, Marsha Young

\(C\) Background information:

-   CCTS has a need for formal capturing confidentiality requirements.
    CCTS 1.0 had security/ privacy issues that surfaced which resulted
    in development of security gaps document

    -   By security grid team, primarily a tech inventory (\~ complete
        -- at least started)

    -   to be implemented in CCTS 1.5 (\~Q1 2009)

    -   Simultaneous with enterprise architecture talks.

    -   No linkage to domain experts: lacks connection to Wendy, Marsha.

    -   Requirements need to be online soon (Requirements and analysis
        scoped for 1.5) relatively short duration. Longer duration may
        arise, but will not be implemented for 1.5 release.
        (Requirements for the 1.5 release need to be public by 1 Sept.
        **Release will occur with or without the security
        enhancements**)

\(W\) Requirements imposed by laws, regulations (several sources, HIPAA
-- privacy/ security, FDA -- data integrity, HHF Common Rule,
regulations for gov't funded projects, requirements for federal
systems... These requirements affect interaction cost.

\(C\) Schedule not set, but January at earliest, based on release of
other projects (based on the release of another project, but schedule is
impending)

> \-- Single institutional boundaries (1.0), not sure if it is the same
> for 1.5. So far, the same for 1.5.

\(W\) CCTS project aims toward being able to share information across
institutional boundaries. Ability to conduct clinical study in several
facilities and be able to share information. So, we want to make sure
nothing we build precludes sharing.

\(C\) Functional profiles of each application are available. Scheduling,
registration, linking subjects to protocols, adverse event recording,
C3D, TA Exchange -- lab data. 1.5 need to determine gaps we have with
security. Grid feels like more security exists than is needed. Some new
functionality and interoperability. Emphasis on security and
architecture.

Scenarios:

1.  Change patient schedule based on adverse events. (Clinicians use
    each of the parts as an integrated suite.) Cares, lab viewer, c3d,
    schedule

2.  Enroll a subject -- c3pr and c3d

3.  Lab data

\(J\) Gap analysis not complete from technical view or requirements

\(C\) Breaks due to lack of requirements gathering

\(J\) Security requirements have been limiting factor in the past

.

Kalpesh Patel (and Kunal)-- CCTS architect (technical contact) also on
CTMS team (needs to be included in weekly meetings)

(Edmond Molaire -- leads dev teams)

Frank Minion, Bill Weems, Wendy Patterson, Marsha Young, (legal
requirements contacts)

**Issue escalation:** Through Kalpesh and the CAT process

**Dependencies** -- Libby and Kenyon need availability of subject matter
experts and technical experts

**[Next step]{.mark}**: Look through existing data -- gap analysis
(Libby),

gain alignment about where we currently stand and what needs to be done
(Wendy, Marsha, Kenyon)

weekly meeting (Malcolm)

Send out Gap Analysis & Functional Analysis (John)

**Project Tasks:** Generate a set of requirements/ use cases
interoperability with story boards/ sequence / activity diagrams (roles
and responsibilities, swim lanes)

I.