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