Vision and Scope

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Jan 30, 2013 (4 years and 7 months ago)

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Vision and Scope Document

for the

caBIG CTMS Study Calendar Module

Version 1.03

Prepared by Warren A. Kibbe

The Robert H. Lurie Comprehensive Cancer Center of

Northwestern University

June 26, 2006

Vision and Scope for <Project>the caBIG CTMS Study Calendar Module


Page
ii


Table of Contents


Tabl
e of Contents

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................................
................................
................

ii

Revision History

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................................
................................
.................

ii

1.

Business Requirements

................................
................................
................................
.

1

1.1.

Background

................................
................................
................................
............

1

1.2.

Business Opportunity

................................
................................
............................

1

1
.3.

Business Objectives and Success Criteria

................................
.............................

1

1.4.

Customer or Market Needs

................................
................................
....................

1

1.5.

Business Risks

................................
................................
................................
.......

2

2.

Vision of the Solution

................................
................................
................................
...

2

2.1.

Vision

Statement
................................
................................
................................
....

2

2.2.

Major Features

................................
................................
................................
.......

3

2.3.

Assumptions and Dependencies

................................
................................
............

4

3.

Scope and Limitations
................................
................................
................................
...

4

3.1.

Scope of Initial Release

................................
................................
.........................

5

3.2.

Scope of Subsequent Releases

................................
................................
...............

5

3.3.

Limitations and Exclusions

................................
..

Error! Bookmark not defined.

4.

Business Context

................................
..........................

Error! Bookmark not defined.

4.1.

Stakeholder Profiles

................................
..............

Error! Bookmark not defined.

4
.2.

Project Priorities

................................
...................

Error! Bookmark not defined.

4.3.

Operating Environment

................................
........

Error! Bookmark not defined.





Revision History



Name

Date

Reason For Changes

Version

Warren Kibbe

June 5,
2006

Revisions to 1.0 bas
ed on Study Calendar
Kickoff call

1.01

Warren Kibbe

June 5,
2006

Revisions from Study Calendar SIG call. In
particular, making PostgreSQL the primary
target and calling out the extension of the study
calendar to additio
nal relational databases was
an outcome of the June 5 call.

We should make a glossary of terms, with many
of the bolded or italicized words such as ‘off
-
tracking’ defined in that glossary.

1.02

Warren Kibbe

June 23,
2006

Scope corrections and limitations
based on SIG
and requirements calls

1.03

Vision and Scope for <Project>the caBIG CTMS Study Calendar Module


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1


1.

Business Requirements

1.1.

Background

The business driver behind the caBIG CTMS Study Calendar Module is the creation of an open
source, standards
-
compliant software application that can be used by organizations that
m
anage patients on cancer clinical trials. The Study Calendar module will support the
application of a
study

template

to study participants and enable the
prospective forecasting

of visit information and provide a framework for reviewing
historical study ca
lendar events
.
Prospective
s
tudies that are linked to patient identifiers and data are
in scope

for this project
include prevention, therapeutic, observational, correlative, ancillary, screening, diagnostic, and
biobanking studies.
These studies may or may

not include consent.
Studies that do not involve
clinical data or studies that are purely laboratory
-
based are out of scope.

Although the Study
Calendar is not explicitly responsible for tracking protocol changes or amendments to the study,
changes to the

study can be consumed by the Study Calendar Module to reflect changes to the
study calendar template and the application of those changes to a participant.

1.2.

Business Opportunity

At this point in time, and open source, open standards
-
based study calendar do
es not exist.

1.3.

Business Objectives and Success Criteria

Although the long term benefit to be derived from the Study Calendar are the standards
-
based
interfaces and data definitions, the short term objectives and measurable success metrics are
around having
a Study Calendar application that enables the creation of a study calendar
template for a study, the
events around the
screening and registration of a participant on a
study, provides a study
-
specific forecast calendar at a patient level, provides a retros
pective
view of participant events, and provides study
-
, participant
-
, and event
-
based reports focused
on the study calendar.

1.4.

Customer or Market Needs

The immediate focus for the Study Calendar Module are NCI
-
designated Cancer Centers,
followed by the Co
operative Groups, Cancer Center
-
affiliates, and finally other organizations
that open NCI
-
sponsored clinical trials. From the Cancer Center perspective, the ability of the
Cancer Center to acquire and host open source software is not correlated with the si
ze, nature
(matrix or standalone), maturity or clinical trial load of the institution. The heterogeneity of the
Cancer Center environments also extends into computational capabilities, platforms, and
operational environments for the clinical research enter
prise at each Cancer Center. Some
similarities are also apparent


many of the Cancer Centers that participate in caBIG have at
least one Oracle license in place, and can host software incorporating Oracle databases.
However, in the Study Calendar SIG, an
informal poll revealed that Ingres, Sybase, and
SQLserver were the relational database platforms of choice at Mayo, Dartmouth and City off
Hope. Therefore, the Study Calendar Module will be built against PostgreSQL and be cross
-
deployable on other relation
al databases, although the validation of additional database targets
will be an adopter task. The technology (Hibernate) that provides the object/relational mapping
for the Study Calendar Module provides this flexibility for little additional work.


Likewi
se, to make the software application as easy to setup and maintain as possible, the
application server technology will be as lightweight as possible and installable through a
Vision and Scope for <Project>the caBIG CTMS Study Calendar Module


Page
2


standard install procedure. The adopter site will be able to install the database

and application
server on the same server, or distribute them for better performance. Client access will be web
-
based,

and will support browsers that follow current web standards
.


1.5.

Business Risks

Clear definitions, buy
-
in from cancer centers and cooperati
ve groups, harmonization with
BRIDG, CTOM, CDISC. Rapid feedback from cancer centers. Delays in identifying and on
-
boarding adopters. Engagement of caBIG stakeholders from the community is paramount, and
the mechanisms for engagement need to be well define
d and mutually acceptable.


2.

Vision of the Solution

2.1.

Vision Statement

The caBIG CTMS Study Calendar Module will support the application of a
study

template

to
study participants and enable the
prospective forecasting

of visit information and provide a
framew
ork for
reviewing historical study calendar events
. The caBIG CTMS Study Calendar
will support studies that include therapeutic, observational, correlative, ancillary, and biobanking
aspects. The standalone Study Calendar module will integrate with the com
ponents necessary
to create study calendar templates (protocol authoring), be able to
instantiate

a template for
study participant and represent study events for that participant. These study events will be
uniquely identified

at a study participant and ev
ent level, enabling the stable linking to external
systems such as patient scheduling systems, laboratory interfaces, adverse event reporting
modules, case report forms, and other event
-
based data that are specified by a study.


The study calendar will se
rve as an event
-
centric hub for linking these data, but the study
calendar module itself will not model or extend into these domains.


The Study Calendar will provide APIs to data for data sharing and application interaction. The
data model will be based
on and harmonized with the caBIG BRIDG model, the CDISC
SDTM/TDM, and CTOM, with the intent that additional modules that can consume or provide
data in compliance with these models can effectively integrate with the Study Calendar Module.
caAERS, the Lab I
nterfaces Module, Financial Billing, EDC (electronic or ‘remote’ data capture
tools), with open source CTMS systems including OpenClinica, and other CTMS modules all
identified as potential targets for application integration.


User Interfaces

A minimal s
tudy calendar template creation interface will be included in the deliverables for the
Study Calendar Module. The module will include stubs for the still to be developed standardized
interfaces that will enable future integration with a complete protocol a
uthoring tool and a study
calendar template repository.


The Study Calendar Module will include interfaces that support
study participant screening

events

and
registration

events
,
participant event tracking

specified by the study, tracking
participant sch
edule deviation
s,
off
-
tracking

of the participant, track
arm assignment
, and
support the entry of study events that are necessary for outcomes analysis but not found on
case report forms, as necessary.


Vision and Scope for <Project>the caBIG CTMS Study Calendar Module


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3


The Study Calendar Module will provide a small cohort

of
study
-
, participant
-
, and event
-
centric reports

chosen by joint prioritization with the Study Calendar SIG
, and provide APIs for
extending these reporting capabilities to meet additional use cases including ad hoc reporting
needs. The Study Calendar Mo
dule will provide views of participants by study that are
necessary for periodic reporting but unless explicitly given a high priority by the SIG will not
include the actual reports. The Study Calendar Module will work in conjunction with modules
such as c
aAERS will provide the necessary data for those reports. Again, the vision is that the
Study Calendar Module is an event hub
, not a data hub, although it will clearly represent and
hold event information. In an idealized environment of interoperable tools,

any

module
connected to the Study Calendar should be capable of pulling events and data through the
study calendar representation from the full collection of integrated CTMS data and workflow
tools.

2.2.

Major Features

The Patient Study Calendar module will ha
ve three functional components that reflect the three
aspects of the data model: a template view, a prospective view, and a retrospective view. Each
of these components has a set of business rules associated with it.


The template view of the Patient Stud
y Calendar module is an electronic representation of the
eligibility/treatment/monitoring/follow
-
up lifecycle for a specific study, as typically listed in the
study parameters table of the study protocol. The template view in the standalone Study
Calendar
module will integrate with the components necessary to create study calendar
templates (protocol authoring) using the BRIDG model and will contain the interface elements
necessary to create a study specific template. The creation of an event and the speci
fication of
the items in a multi
-
level event container is the purview of the protocol authoring module. The
representation of that specification can be held by either the protocol authoring or study
calendar system. However, a basic interface allowing the
creation of a multi
-
level event
container will be part of the stand alone Study Calendar Event Module application. An example
of such an event is a blood draw that is scheduled for day 15 of cycle 1 of the patient calendar,
with the specification that the
blood draw is for three purple
-
top EDTA tubes (3
-
10ml), one used
for a CBC, one for archival to a biobank, and one for CA
-
125 (ovarian cancer).


The prospective view is the result of applying the template view to a specific participant with a
start date.
The prospective view is an instantiation of the template for a study participant and by
combining the start date of that participant with the days specified in the template view, discrete
dates for future events can be calculated. This component will proj
ect the future occurrence of
each study event
for that participant
, working within the business rules of the organizations
involved (hospital, pharmacy, clinical research office, etc.) and the protocol. The prospective
view is where the workflow and busin
ess rules for notification of pending patient visits, pending
lab tests and accrual definitions are applied.


These study events
will be uniquely identified

at a study participant and event level, enabling the
stable linking to external systems such as p
atient scheduling systems, laboratory interfaces,
adverse event reporting modules, case report forms, and other event
-
based data that are
specified by a study. Likewise, the Study Calendar Module will provide those systems with
methods to store stable iden
tifiers for linking to associated data for an event in the Study
Calendar.


The third component to the Patient Study Calendar module is the retrospective view. Once the
date of an event created by the prospective component has passed, details about that e
vent
must be entered to reconcile if it happened, when it happened, and provide a unique, stable
identifier for these events that can be used by other modules and systems.


Vision and Scope for <Project>the caBIG CTMS Study Calendar Module


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4


Each of these components will include a select set of reports

as defined by the S
tudy Calendar
SIG and adopters
, with the prospective and retrospective views accessible by APIs that can
provide study
-
, participant
-

or event
-
centric slices of the study calendar. These reports and
APIs will support the study calendar requirements of th
e various users of the Study Calendar
Module, including physicians, nurses, pharmacists, clinical research coordinators, study
financial coordinators, and participants.


Functionally, the Study Calendar will include features to support patient screening
and
registration, adaptable schedule definitions and security model implemented using the CSM that
is suitable for multi
-
site protocols, alerts for upcoming events and missed events, ability to track
and report on dates of anticipated versus actual events,

and complete reporting of patient
accrual, missed events, and schedule deviations. The Patient Study Calendar will support the
accrual definitions necessary for CCSG reporting.


2.3.

Assumptions and Dependencies

A key outcome of the project will be the impleme
ntation of a BRIDG model
-
derived architecture
that is harmonized with CTOM and CDISC, utilizing NCICB components such as caCORE SDK,
CSM and caAdapter (HL7 SDK) to prepare for subsequent achievement of caBIG Gold
-
level
compatibility, inclusion of the Study

Calendar on caGrid, and use of the Study Calendar as a
core component of the caBIG CTMS ecosystem alongside systems such as C3D, caAERS, and
OpenClinica.


The project team will pursue a phased approach to ensure well
-
coordinated development and
completio
n of timely, quality deliverables. Project tasks include planning, stakeholder and caBIG
CTMS Study Calendar SIG engagement, design, and implementation. These tasks will leverage
and integrate with various caCORE SDK components, while placing the fundament
al model
-
driven development architecture in place to achieve gold compatibility and incorporation into
caGrid at a later stage. Engagement of caBIG stakeholders from the community is paramount,
and the mechanisms for engagement need to be well defined and
mutually acceptable.


3.

Scope and Limitations

The current funded cycle of the Study Calendar Module will result in an operational Study
Calendar that provides interfaces for creating the Study Calendar Template for each study, and
provides workflow managemen
t interfaces for the eligibility/ registration/ treatment/ monitoring/
follow
-
up lifecycle at the level of a participant. The specific events in the eligibility/ registration/
treatment/ monitoring/ follow
-
up lifecycle will be defined in the Study Calendar

Template for a
specific study. The Study Calendar will provide APIs, UI screens, and a small set of core reports
of screening and registration information for participants on a study, study
-
specified events, and
general workflow management tools for the p
atient relative to the study requirements for that
protocol. The Study Calendar will not provide tools for tracking protocol creation, CPSRMC
review, IRB review (neither initial or periodic), track adverse events, the reporting of adverse
events, tools for

tracking and managing periodic reports to sponsors or insurers, the creation of
financial milestones, hold financial data, hold clinical or laboratory summaries or results. As
stated in section 2.1:


The study calendar will serve as an event
-
centric hub f
or linking these data, but the study
calendar module itself will not model or extend into these domains.


The Study Calendar will, however, be able to provide stable, unique identifiers to patient events
that can be used by systems or modules that manage
those domains so that a calendar
-
driven
Vision and Scope for <Project>the caBIG CTMS Study Calendar Module


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5


view of any of those items can be produced. The Study Calendar Module will also provide
methods to systems supporting these data for the storage of stable, unique identifiers enabling
the linking of data from those s
ystems to specific events in the Study Calendar Module.
Although our vision is to make all aspects of the Study Calendar Module completely open and
interoperable, we anticipate that the initial release will primarily offer data
-
level interoperability
rathe
r than complete access to all methods and interface elements in the study calendar
application.

3.1.

Scope of Initial Release

We will use an Agile approach to software design, where we will release many small iterations
of
production quality

code so that we can

get finished code into the hands of the adopters
rapidly for their evaluation so we can rapidly identify areas that are stable as well as areas in
need of additional analysis and modeling. The initial release will focus on the study calendar
template, whi
ch is the study
-
centric view of the study calendar. We will include the UI elements
for creating and editing the template elements, and reports for reviewing existing templates and
viewing the elements present in a template. Additional details on the deliv
erables are available
in the Project Management Plan.


3.2.

Scope of Subsequent Releases

The Study Calendar six month timeline includes four releases, roughly every six weeks. Each

release will include additional features and build on the previous release.
Add
itional details on
the deliverables are available in the Project Management Plan.