Title: Joyce C' Niland, PhD
1CTMS WorkspaceAdverse Event SIG Update
January 30, 2006
Joyce C. Niland, PhD Abdul-Malik Shakir Hemant
Shah, MD City of Hope
2Adverse Event SIG Update
- Overview
- caAERS Project Status (J. Niland)
- Evolution of the caAERS Model (AMS)
- Metadata Project / caAERS CDEs (H. Shah)
- Lessons Learned to Date (J. Niland)
- AE SIG Goals for 2006 (AE SIG)
- Summary 3 / 4 Reporting Tool (RDX SIG)
3Adverse Event SIG Update
4AE SIG Activities to Date
- Develop a vision for caAERS (12 modules)
- Establish highest priorities
- Gather user requirements identify issues
- Create static and dynamic models
- Initial system design and prototyping
5Componentized Approach to caAERS
Clinical Trial Participants
IRB
6Componentized Approach to caAERS
11
Public SafetyProfiling Website
CTC RelatedLab Data
CTC RelatedQualitative Data
Clinical Trial Participants
8
7
Safety Profiler
Grade 1- 5 AEs
Automated CTC Grading
caBIG Adverse Event System (AES)
2
1
3
AE Data
Patient/Protocol Data
4
12
Transmission to External Agencies
Internal Routingand Review
10
Publication of Summary Results
9
IRB
PI/CRA
PatientSelf-Reporting
DSMB Monitor
5
6
Data Mining forRisk Patterns
Transmission to caBIG AE Data Warehouse
7Interviews and Collaboration
-
- As issues emerged, entered into an Issues Log and
distributed to SIG members for discussion
8Use Cases, Business Diagrams, and Detailed Use
Cases
9Use Case-Driven Data Dictionary
- Serves as the caAERS data dictionary
- Provides mapping among the varied
representations - Data elements derived and reconciled via use
cases - Maintained as an Access database
- Provides customized views by reporting agency
- Feasible for terminology management
10Vetting with the AE SIG
- 15 AE SIG calls in 2005
- 13 CTMS Working Group calls
- Visits to Mayo, Pittsburgh and UCI
- Teleconferences with Wake Forest, Mayo, Yale,
CTEP, and DCP
11Thank You!
- To All SIG Participants
- With special thanks to the following SIG members
and their fellow staff members
12Vetting of Data Flow Scenarios with AE SIG
13Process for Creating AE
- AE request initiated from local CTMS(includes
protocol and study participant data) - In caAERS, user presented with Active AEs--
new skeletal AEs-- incomplete AE entries--
AEs requiring expedited reporting - User enters core AE data to establish if its a
duplicate (previous entries displayed)
14Process for Creating AE (2)
- User enters baseline AE data system determines
reporting requirements - If expedited reporting required, extended data
entered and related AEs identified for report - Incomplete entries can be saved and are displayed
on Active AE list until completed - Expedited Report generated and available as PDF
and XML Message
15Conceptual Data Model (CDM)
16Expert HL7 Modeling Consultant
17Adverse Event SIG Update
- Evolution of the caAERS Model
18Adverse Event SIG Update
- Metadata Project / caAERS CDEs
19Adverse Event SIG Update
20caBIG Adverse Events Reporting System (caAERS)
Prototype Architecture
21Lessons Learned
- caAERS is a much more complex model than those
run through the caCORE SDK tools previously - SDK Code generation tools do not handle complex
data types, abstract classes needed to flatten
the model to utilize tools - To meet caDSR constraints, data types need to
resolve to Java primitives - Tools generate read-only APIs, limited
functionality with regard to generating secure
writable APIs - Common Security Model (CSM) tool currently not 21
CFR Part 11 compliant building security module
for caAERS - caFramework tools provide for development of
basic forms, may not meet the best practices for
caBIG GUIs - Harmonization with BRIDG, ICSR, etc is critical,
first session to be held soon
22Harmonization Process of Subcomponents of the
BRIDG Model
caAERS
23Adverse Event SIG Update
24AE SIG Goals for 2006
- Proposed Goals for Discussion
- Complete caAERS prototype - April 2006
- Work with caAERS adopters to develop test plans
and deploy/evaluate prototype
25- Creating a software system without delivering
anything to the users until everything is done,
is like constructing a complete office building
on its side, then trying to lift it into
position.
26AE SIG Goals for 2006
- Proposed Goals for Discussion
- Complete caAERS prototype - April 2006
- Work with caAERS adopters to develop test plans
and deploy/evaluate prototype - Work with CTMS WS, Architecture SIG, and other
SIGs to identify an open source workflow engine - Build caAERS V2 Modules 1-4 (CSM, configurable
rules/triggers for reporting, all agencies) - Requirements gathering, design, and build of CTC
Automation Tool for lab data (Module 8) - Other ideas / suggestions?
27Questions?