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 (FormsNet R ) Electronic Data Transmission (EDT) sending data directly from one database to another without manual intervention
Validated rules and data mapping can be used repetitively, improving data accuracy and speed of acquisition 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)
How Do We Get From EMR Program database Sponsor IRB Compliance Etc. Data manager or To chart HRPP program Insurers? Sponsors hospital etc. Seamless data interchange NIH
Advantages/Disadvantages EDC SITE EFFORT/ COST FREQUENCY ACCURACY Registry (CIBMTR) lower one time Audit required Center higher repetitive Error prone
Advantages/Disadvantages EDT SITE EFFORT/ COST FREQUENCY ACCURACY Registry (CIBMTR) unchanged one time Reduced Audit burden Center lower one time Error-free after IT audit 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 11 Charles Martinez Jane Pollack Robinette R David Patton Jose Galvez Dianne Reeves Wendy Ver Hoef Mary Cooper Becky Angeles Smita Hastak
So What?
SCT/BMT Domain Model With Integration Engine (IE) Conceptual Design I E CDE Mapping SCT Domain Model Static I E CDE Mapping AGNIS FormsNet Inst. Legacy Database XML Rules Mapping SOA BRIDG/RIM SOA Rules Mapping SOA GRID Audit Tracking GUI Mapping LAB HLA ADT Audit Tracking GUI Mapping NES COPPA SCTOD Site specific mapping Cancer Center CTMS One time static mapping pushed to all centers GRID NCI FDA 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
AGNIS Curated Forms Currently Available 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
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 centerspecific 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