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Structured Protocol Representation for the
Cancer Biomedical Informatics Grid:
caSPR and caPRI
Vision of the SPR SIG
• To define a computable protocol representation that
supports the entire life-cycle of clinical trials protocol,
and develop tools that use these protocol
representations. These tools should be standardsbased, caBIG compliant and assist users in creating,
maintaining, and sharing clinical trials information.
• The clinical trials protocol representation will serve as
a foundation for caBIG modules that support all
phases of the clinical trials life cycle, (including
protocol authoring) and be developed to meet user
needs and requirements.
• At every stage, we will evaluate and test our work
Goals of SPR SIG
• Long term goal
– Create a structured protocol representation that supports the
entire life cycle of clinical trial protocols and serves as an
integrative foundation for caBIG compliant applications
• Short term goals
– Create the core data elements to describe a clinical trial
protocol (classes)
• CDISC data model as a starting point
• Validate model with user input
– Demonstrate the use of this SPR in a tool to populate the
representation (instances)
• Protocol registration
– Rapid iteration from use cases to early prototype
• Learn from this process and iterate
Development tasks
• caSPR –Structured Protocol Representation
• caPRI –Protocol Representation Instantiator
Initial scope of caSPR
• From the time that a protocol is entered into an electronic
system to the time the protocol is ready to enroll patients
– Protocol demographics
• Title, PI, sponsor, etc
• Leverage use cases and other data elements that are being
developed in other SIGs
– Other SIG focus areas (incorporate their information and coordinate
as their information becomes available)
• Limit scope to learn from the process and create early prototype
Enter protocol
into electronic
system
Enroll first
patient in CT
Entering data using caSPR
• caSPR will evolve over time
– We will start with the core elements, many additional
elements will be added throughout the project
• How do we keep our application up-to-date?
• How do we iterate rapidly?
• Can we construct a flexible framework for entering
protocol information using caSPR?
Proposed caPRI System Description
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caPRI
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caSPR
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Layout
specification
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Legacy data
specification
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Task context Business
information
Rules
Protocol Database
CaPRI integration into class-level tools
caPRI
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Instance Level
Class Level
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UML
XML
model
CDE Developer tool
caDSR
NCI
Thesaurus
UML
models
CaPRI integration into system-level tools
System Level
Legacy System
API
Applet within
Application
Stand alone
Application
Others?
Instance Level
caPRI
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CDE Developer tool
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Class Level
Survey Results and User Requirements
Gathering
• A word about use case construction around core data
elements….
– This is hard
• Use cases are often “one off” from the structured protocol
representation
– Clinical trial registry (users are searchers—doctors, patients, etc)
– Summary 4 (generation of the report is downstream of entering
core data elements)
– Adverse event reporting (requires elements that identify protocol)
• The core data elements are the Venn Diagram of all possible
use cases
– Not feasible for a initial prototype
• The life cycle is a cycle so a beginning and end are hard to
define
Our initial approach
– Use CDISC protocol representation elements as an initial set
• Evaluating CDISC elements and comparing to other
representations
– CTMS workspace participants
– HL7
– Cooperative groups
– Validate and clarify processes at adopter sites using use
cases, surveys, and experts
– Refine these elements in consultation with CDISC, HL7, and
experts in caBIG to match needs of the caBIG community
caSPR
Research
Development
Pre-Trial Setup
New Idea
Generation
Patient
Enrollment
Data
Analysis
Patient
Management
Financial
& Billing
Reporting &
Administration
caSPR
1 Register protocol
2 Internal tracking
(IRB,PRC, fiscal, etc)
13 PI protocol authoring
3 CT registry to disseminate
information
12 Custom report generation
Research
Pre-Trial Setup
Development
11 Data mining
10 Trial results repository
9 Statistical analysis
New Idea
Generation
Patient
Enrollment
Data
Analysis
Patient
Management
Financial
& Billing
4 Pt eligibility determination
5 Pt registration
6 Patient Treatment calendar
Reporting &
Administration
Financial and billing
information
7 Custom case report forms
Budgeting calendar
CDUS reporting
8 Summary 4 reporting
Pt laboratory information
Adverse event reporting
caSPR: Year 1
1 Register protocol
2 Internal tracking
(IRB,PRC, fiscal, etc)
13 PI protocol authoring
3 CT registry to disseminate
information
12 Custom report generation
Research
Pre-Trial Setup
Development
11 Data mining
10 Trial results repository
9 Statistical analysis
New Idea
Generation
Patient
Enrollment
Data
Analysis
Patient
Management
Financial
& Billing
4 Pt eligibility determination
5 Pt registration
6 Patient Treatment calendar
Reporting &
Administration
Financial and billing
information
7 Custom case report forms
Budgeting calendar
CDUS reporting
8 Summary 4 reporting
Pt laboratory information
Adverse event reporting
caSPR:Year 3
1 Register protocol
2 Internal tracking
(IRB,PRC, fiscal, etc)
13 PI protocol authoring
3 CT registry to disseminate
information
12 Custom report generation
Research
Pre-Trial Setup
Development
11 Data mining
10 Trial results repository
9 Statistical analysis
New Idea
Generation
Patient
Enrollment
Data
Analysis
Patient
Management
Financial
& Billing
4 Pt eligibility determination
5 Pt registration
6 Patient Treatment calendar
Reporting &
Administration
Financial and billing
information
7 Custom case report forms
Budgeting calendar
CDUS reporting
8 Summary 4 reporting
Pt laboratory information
Adverse event reporting
caSPR: Year 5
1 Register protocol
2 Internal tracking
(IRB,PRC, fiscal, etc)
13 PI protocol authoring
3 CT registry to disseminate
information
12 Custom report generation
Research
Pre-Trial Setup
Development
11 Data mining
10 Trial results repository
9 Statistical analysis
New Idea
Generation
Patient
Enrollment
Data
Analysis
Patient
Management
Financial
& Billing
4 Pt eligibility determination
5 Pt registration
6 Patient Treatment calendar
Reporting &
Administration
Financial and billing
information
7 Custom case report forms
Budgeting calendar
CDUS reporting
8 Summary 4 reporting
Pt laboratory information
Adverse event reporting
caSPR: Other SIG contributions
1 Register protocol
2 Internal tracking
(IRB,PRC, fiscal, etc)
13 PI protocol authoring
3 CT registry to disseminate
information
12 Custom report generation
Research
Pre-Trial Setup
Development
11 Data mining
10 Trial results repository
9 Statistical analysis
New Idea
Generation
Patient
Enrollment
Data
Analysis
Patient
Management
Financial
& Billing
4 Pt eligibility determination
5 Pt registration
6 Patient Treatment calendar
Reporting &
Administration
Financial and billing
information
7 Custom case report forms
Budgeting calendar
CDUS reporting
8 Summary 4 reporting
Pt laboratory information
Adverse event reporting