Get documents about "The caBIG� Strategic Plan - Download as PowerPoint
Document Sample
Objectives and Structure of the
Clinical Trials Management
Systems Workspace
John Speakman
Associate Director, Clinical Trials Products and Programs
NCI Center for Biomedical Informatics and Information Technology
john.speakman@nih.gov
caBIG™ Clinical Trials Management Systems
Workspace Face-to-Face Meeting
May 30 – 31, 2007
Portland, Oregon
May 2007
Pilot Special Interest Groups
(Green=Original, Blue = caBIG Additions, Orange = CTWG Additions)
Routine Data
Exchange Financial Billing
Structured
Study Calendar Protocol
Representation
Adverse Event Laboratory
Reporting
CTMS Steering Committee Interfaces
Investigator
And Site Clinical Trials
Credentialing Database
CRF
Systems
Standardization
I/H
2 2
Clinical Trials Activities
3/2007
• IOTF Janus
• IOTF FIREBIRD
• NCICB Clinical Data System (CDS)
•
•
NCICB DCP/DESK
NCICB Serious Adverse Event Reporting System
“NCICB”
• NCICB Clinical Trials Object Model (CTOM)
• NCICB caMatch
• NCICB Cancer Central Clinical Database (C3D)
• caBIG C3PR
• caBIG Protocol Lifecycle Tracking (PLT)
• caBIG caAERS
• caBIG BRIDG
• caBIG Study Calendar
• caBIG caXchange
• caBIG CTMS Integration Project
• caBIG Vendor Compatibility and Grid Enablement
• CTWG CTDB “caBIG”
• CTWG Study Initiation Tool
• CTWG Investigator & Site Credentialing Repository
• CTWG Case Report Form Standardization
3 • CTWG Systems Interoperability and Harmonization 3
caBIG™ Org Chart for Clinical Trials
Initiative
Management Team Steering
General Contractor
(NCICB, Coordinating Committee
(Booz Allen Hamilton)
Center for Clinical (Strategic View)
Trials, General
Contractor)
Special Interest Group Task Force(s)
(Four in Total) (Tactical view, focused primarily on
CTWG Informatics Initiatives, one
per Special Interest Group)
Project Execution Teams
Project Execution Teams
Project Execution Teams
Developers Adopters
Relationship Legend
Tasking
Informational
4 4
What is the Clinical Trials Management
Systems Workspace Trying to Achieve?
• Facilitate the planning and instantiation of clinical
trials, (and the monitoring of trials once they are
instantiated)
• Facilitate the conduct of clinical trials
• Facilitate the reporting and sharing of clinical trial
data to existing/new destinations
• Achieve interoperability
• Increase the ability of systems to access and use the
data and functionality of other systems
• Facilitate the integration of new sources and
destinations of data
5 5
In Domain-speak…
Planning / Conduct Reporting /
Monitoring Sharing
Interoperability
caCORE (Vocabularies & Common Data Elements)
6
6 caGRID (Underlying Architecture)
Enterprise Special Interest
Groups and Projects
Planning/ Conduct Reporting/
Monitoring Sharing
•Standardized Case
Report Forms
•Investigator and Site •Clinical Trials Database
•Cancer Central Clinical
Credential Repository •Routine Data Exchange
Database (C3D)
•Study Initiation Tool •Clinical Trials Object
•Participant Registry
•Protocol Lifecycle Model
•Laboratory Interface
Tracking •Janus (FDA Repository)
•Financial/Billing
•FIREBIRD •Adverse Event Reporting
•Study Calendar
•DCP/DESK and Collection
•Subject Prescreening
•Clinical Data System
•Vendor Systems
(CDS)
Interoperability
•System Interoperability and Harmonization
•Structured Protocol Representation (BRIDG)
•Clinical Trials Interoperability Project
7 7
We Need Community Participation
• “Community” for the Enterprise Program is much bigger
than “Cancer Center IT People”
• Not just Cancer Centers
• Cooperative Groups, CCOPs, SPOREs
• Not just IT People
• Investigators, Data Managers, Statisticians, CRAs/RSAs
• Steering Committee is operational
• Task Forces are being set up
• We will seek focused expertise and experience on specific
projects (and at specific meetings)
• Developers will convene stakeholder meetings on specific
projects
8 8
Since we last talked
• Task Force RFI responses received (lots!)
• It was a “Request for Information”, not an RFP
• We are looking for substantive participation
• Direct expertise and experience in clinical trials and the
delivery of informatics solutions to support them
• Initial focus of Task Forces will be on the Clinical Trials
Working Group initiatives, but:
• CTWG initiatives will not be carried out in isolation, nor
de novo
• CTWG initiative meetings will resume as Task Forces are
stood up
• Steering Committee to meet again August 2
9 (Rockville/Bethesda area, MD) 9
What about the pilot SIGs?
• Case-by-Case basis
• Task Forces will be involved
• We will have discussions with
the Pilot SIGs/SIG Leads
• We are NOT planning to
abandon any of the work
carried out thus far
10 10
Objectives of the rest of this meeting
• Find out how the new management structure will work
• Discussion with the Steering Committee
• Find where your favorite CTMS project went
• And how to get involved in the development
• Review the current status
• Opportunities for scope discussion and validation
• Discuss data sharing – opportunities and challenges
• Understand how NCI will support your site’s use of caBIG
(and CTMS)
• Find a place to meet in September (tentative Sept 25-26 or
Sept 26-27)
• East Coast’s turn…
11 11
Privacy/Intellectual Capital Terms &
Conditions Decision Tree – DSIC WS
Decision Tree for Privacy/Intellectual Capital Terms and Conditions
Data/Specimens
IP Value Data Sensitivity IRB/ Institutional Restrictions
(Need for Protection) (Regulatory Status) (Policy/ Consent Limitations) Sponsor Restrictions
(Contract Terms & Conditions)
Examples: is the data subject to a restrictive Do your Institution's or IRB's policies or the applicable Do terms and conditions in any sponsored
Do federal or state law or your institution's
license? Is it related to an invention report informed consent documents explicitly or implicitly agreements prohibit or restrict disclosure
policies prohibit or restrict disclosure?
you have or intend to file with your institution? restrict or permit disclosure (e.g., “no commercial use”)? outside institution or to caGRID?
Explicit Consent
High Classified Research/
Identifiable Data Limitations or
Major Restrictions
Restrictions
Coded/Limited Data Delays or Other
Medium Policy Limitations
Set Moderate Restrictions
De-Identified/
None/Low Generic Registry or
Anonymized Data Set No Restrictions
caGRID Permission
ANY of the following: ANY of the following: ALL of the following:
- high IP value - moderate IP value - no IP value
- high sensitivity data (e.g., PHI) - moderate sensitivity data (e.g., LDS) - low sensitivity data
- significant IRB/consent restrictions - limited institutional or IRB policy - no IRB restrictions
- major sponsor restrictions restrictions - no sponsor restrictions
- moderate sponsor restrictions
12 Bi-Lateral or Multi-Lateral MTA
Standardized Click-Through
Terms and Conditions
“EZ Pass” - General Website Terms of
Use
12
Q&A
13 13
