beyond electronic data capture (edc) to data sharing: update of
TRANSCRIPT
Beyond Electronic Data Capture (EDC) to Data Sharing: Update of
Selected ASBMT/CIBMTR/NMDP IT Programs
Roy B. Jones, PhD MD
Definitions
• Electronic Data Capture (EDC) – manually
copying data from one source to a new
application (FormsNetR)
• Electronic Data Transmission (EDT) –
sending data directly from one database to
another without manual intervention
Data Sources
• We are rapidly moving away from paper to
electronic data sources (EMR’s,
departmental databases)
• This allows derived data to be obtained
thru rules (day to engraftment)
• Validated rules and data mapping can be
used repetitively, improving data accuracy
and speed of acquisition
How Do We Get From
or
To
program
hospital
HRPP
NIH
Insurers
Sponsors
etc.?
EMR
chart
Seamless data interchange
Sponsor
IRB
Compliance
Etc.Data manager
Program
database
Advantages/Disadvantages
EDC
SITE EFFORT/
COST
FREQUENCY ACCURACY
Registry
(CIBMTR)
lower one time Audit required
Center higher repetitive Error prone
SITE EFFORT/
COST
FREQUENCY ACCURACY
Registry
(CIBMTR) unchanged one time
Reduced Audit
burden
Center lower one time Error-free
after IT audit
Advantages/Disadvantages
EDT
There are clear advantages for any intermediate
or larger center to convert to EDT
What is our track record in
converting from EDC to EDT?
BAD
Only two centers have sent production data
to the SCTOD using EDT !
How can Centers Convert From
EDC to EDT?
• Adapt current center applications to
support EDT
Not Working
• Migrate data to BRIDG data structure
• Purchase commercial solutions which can
support EDT to SCTOD
Biomedical Research Integrated Domain Group
BRIDG
• NCI, FDA, CDISC (PhRMA), HL7
• Computer Data model annotated with
CDE’s• Protocol-driven research and its associated regulatory artifacts: i.e. the data, organization,
resources, rules, and processes involved in the formal assessment of the utility, impact, or other
pharmacological, physiological, or psychological effects of a drug, procedure, process, or device
on a human, animal, or other subject or substance plus all associated regulatory artifacts required
for or derived from this effort, including data specifically associated with post-marketing adverse
event reporting.
• http://www.bridgmodel.org/
BRIDG/SCT PROJECT
• BRIDG model expanded to include all
required SCT concepts
• BRIDG model annotated with 1900
common data elements (CDE) for SCT
• Project completed and approved 10/2012.
We now have a standardized, approved database
which can hold all data required by CIBMTR/SCTOD.
It is freely available.
Meeting Participants – 7/27/2012
Charles Martinez
Jane Pollack
Robinette R
David Patton
Jose Galvez
Dianne Reeves
Wendy Ver Hoef
Mary Cooper
Becky Angeles
Smita Hastak
11
So What?
AGNIS
LAB
BRIDG/RIM
SCT Domain Model
GRID
SCTOD
FormsNet
Inst. Legacy
Database
GRID
FDANCI
I
E
CDE
Mapping
Rules
Mapping
Audit
Tracking
GUI
Mapping
Static
I
E
CDE
Mapping
Rules
Mapping
Audit
Tracking
GUI
Mapping
Cancer Center CTMS
HLA ADT
SOAXML SOA
SCT/BMT Domain Model
With Integration Engine (IE)
Conceptual Design
One time static
mapping pushed
to all centers
Site specific
mapping
SOA
NES
COPPA
Figure 1
Proof of Concept
• >10,000 forms successfully transmitted from MDACC database to SCTOD
• SCT-annotated BRIDG Model (v. 3.2) design completed and published: http://bridgmodel.nci.nih.gov/download_model
– >1900 data elements included
• Vendor expressions of interest
BMTweb Outcome
Data Dictionary
IE mapping 2
Form2000 - Recipient Baseline Data
Form2004 - Infectious Disease Markers
Form2005 - Confirmation of HLA Typing
Form2018 - Hodgkin and Non-Hodgkin Lymphoma Pre-HSCT data
Form2100 - 100 Days Post-HSCT Follow-up Form
Form2118 - Hodgkin and Non-Hodgkin Lymphoma Post-HSCT data
Form2200 - Six Months to Two Years Post-HSCT Data
Form2300 - Yearly Follow-Up for Greater Than 2 Years Post-HSCT data
Form2400 - Pre-Transplant Essential Data
Form2450 - Post-Transplant Essential Data
Form2451 - Chimerism Studies
Form2455 - Selective Post-Transplant Essential Data
Form2900 - Recipient Death Data
AGNIS Curated Forms Currently
Available
System Benefits
• Encourage SCT centers to adopt single database design– Can continue to use own applications– Reduce costs and transcription errors by total
electronic data transmission– Encourage greater data sharing
• Encourage vendor adoption or interfacing to a uniform relational data model
• Assess whether this concept could be adopted more broadly in oncology for outcomes reporting
• Meaningful Use qualification
What’s Next?
• Fund development of static interface engine (IE) (BRIDG
-> SCTOD)
• Publish RFA to identify vendors to develop center-
specific IE’s
• Convince vendors to incorporate BRIDG concepts into
their products
• Allow centers to test the BRIDG/SCT concept
Acknowledgements
• NCI caBIG/CBIIT Dianne Reeves
• CIBMTR Doug Rizzo, Robinette Renner
• NMDP Jane Pollack, Martin Meiers
• ASBMT IT Committee