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Human Studies Database (HSDB) Application at Duke University Swati Chakraborty, ME AMIA – TBI-CRI Joint Meeting March 23, 2012
Human Studies Database (HSDB) Application at Duke University
Swati Chakraborty, ME
AMIA – TBI-CRI Joint Meeting March 23, 2012
• Overview of Current Landscape– Duke University Research site – Duke Clinical Research Institute – Data Coordinating Center
• HSDB Application Scope • Proposed Strategic Solution
– Changes towards Future state– Critical Success Factors
• Discussion & next step
Outline
DUKE UNIVERSITY MEDICAL CENTER
• Academic Medical Center– Education– Research– Patient Care
• Tertiary Care/Level A• 4 Hospitals• 150+ Clinics and Practices• 1500+ Beds
Jeff Ferranti et al.
• World’s largest ARO• Full-Service Capabilities• A global coordinating center for multi-
center clinical trials • Founded in 1969 Duke Databank for
Cardiovascular Diseases • >20 years in >20 therapeutic areas• 900+ staff and 120 faculty• Over 4,600 manuscripts in peer-
reviewed journals• Over 420 projects in 64 countries• Over 579,900 patients
Big Ship !
• Research portfolio - no institutional mechanism to capture or report
• Project information exists in many siloed systems• No systematic method to collate data • Most project information managed in systems/
spreadsheets by individual departments, SBR’s and research personnel
• Reporting attempt - inefficient and inaccurate• Leadership level monitoring of research portfolio –
almost impossible !
Duke Research Systems
Duke Research Systems
Scholars@Duke Architecture
D.E.D.U.C.EDuke Enterprise Data Unified Content Explorer
• on-line research tool for Duke investigators access to clinical information thru EHR
• Aggregate - operations, quality and research• Secondary analysis, cohort selection• demographics, lab data, ICD-9 diagnoses,
CPT procedures, inpatient meds, CPOE orders
Big Ship !
• Research portfolio - no institutional mechanism to capture or report
• Project information exists in many siloed systems• No systematic method to collate data • Reporting attempt – incomplete • Most project information is managed in various
systems like EPM, CTMS, PACT and research personnel – Leadership level portfolio monitoring - Dashboard a
snapshot in time
DCRI - Current State
DCRI - Current State
DCRI – Key systems
DCRI Systems
CTMS - Duke vs DCRI
DCRI CTMS – Site status valuesNAME Standard Value
VAL Substatus /reason for status
SUB_TYPE Actual Status values
Site Status Active Active Active Stop Active Stop Approached Approached Approached Stop Approached Stop Closed Closed Competing trial Competing trial Interested Stop Competing trial Competing trial Approached Stop Contract issues Contract issues Interested Stop DCRI decided not to use site DCRI decided not to use site Approached Stop DCRI decided not to use site DCRI decided not to use site Interested Stop Decided not to participate Decided not to participate Approached Stop Decided not to participate Decided not to participate Active Stop Decided not to participate Decided not to participate Interested Stop Entered Entered Feasibility Questionnaire Feasibility Questionnaire Approached IP not available IP not available Active Stop IP not available IP not available Interested Stop IRB did not approve IRB did not approve Interested Stop IRB related issues IRB related issues Active Stop Interest Questionnaire Interest Questionnaire Approached Interested Interested Interested Stop Interested Stop Other - see status comments Other - see status comments Interested Stop Other - see status comments Other - see status comments Active Stop Other - see comments Other - see status comments Approached Stop Regulatory compliance issues Regulatory compliance issues Active Stop Regulatory compliance issues Regulatory compliance issues Interested Stop Safety issues Safety issues Active Stop Site unresponsive Site unresponsive Interested Stop Site unresponsive Site unresponsive Active Stop Unable to Contact Unable to Contact Approached Stop
Big Ship !
Future State !
Courtesy - Architecting Software the SEI way – SEI – CMU
Future State !P r o c e d u r e s a n d m e t h o d s
d e f i n i n g t h e r e l a t i o n s h i p o f t a s k s
T o o l s a n d e q u i p m e n t
P e o p l e w i t h s k i l l s , t r a i n i n g , a n d m o t i v a t i o n
A
B
CD
P R O C E S S
• IRB - gatekeeper to all studies – site based research to DCC• Strategy for Ongoing Consolidations• Electronic health record - Epic
Ongoing Progress so far……
Enterprise Level Solution - RPR
• Centralized Data Repository - allow storage of project data from multiple systems
• Business Process Flow – Institutional unique ID - all research projects, across systems, lifecycle
• Research Service – One stop shop - investigators maintain grants
• Efficiency - Basic info collected once & shared • Portfolio Management – Access to systems (SPS, eIRB, SAP/R3) -
warehouse reporting and tracking
• Enable interconnectivity - thru identifier, cross system reporting
• Operational boundaries – IRB Approvals, Grants management
Solution - Research Project Registry
Policy level - VC research -- TMQF– Need mandate at institution level – Need culture change – Need new business practice
•Requires “broad view” of research at Duke – how individual projects fit into portfolio and why it is important•Data must be current and readily available •Must be interfaced whenever possible to existing systems•Research personnel must incorporate the registry as part of day to day workflow
Critical Success Factors
Duke Research Systems
Research Project Registry (RPR)
SPSSAP R/3
eIRB
check
Sponso
red
grant/p
roject No
check
Sponso
red
grant/p
roject No
Che
ck P
roje
ct N
oC
heck
Pro
ject
No DFAC
Faculty/Investigator
appointment, contact
Faculty/Investigator
appointment, contactCheck Associated
fund code
Check Associated fund code
Leadership ReportsLeadership
Reports
IACUC Check animal project No
Check animal project No
eResearch
Send protocol number
Send protocol number
Master Agreements
Check contract project NoCheck contract project No
AcademicOutput
Che
ck IR
B N
oC
heck
IRB
No
Enterprise Level Services 1.0
Research Program-Project-Protocol Services
1.0.1Research Program
Registry (RPR) Services
1.0.2Grant
Management Services
1.0.4Research
Resources Services
1.0.5Standard
Compliance Services
1.0.6Support Services
1.0.1.2IRB registry
Services
1.0.2.1Grant Services(Opportunities)
1.0.2.2Grant Services
(Awarded)
1.0.2.3Grant Services (publications)
1.0.2.4Grant Ancillary
Services (Patent)
1.0.4.1Investigators
Registry Services
1.0.4.3Bio-bank resources Services
1.0.4.5Omics Resource
Services
1.0.4.6Research Resource Network Services (DIRECT)
1.0.5.2Other ext Standards
(BRIDG/HSDB)
1.0.5.3Other Internal
Standard Services
1.0.6.1Data
Governance
1.0.6.4Protocol Consent Services
1.0.6.2Metadata Services
1.0.6.3Workflow /interface
1.0.4.2Clinical
Resource Services
1.0.1.3CTMS registry
Services
1.0.1.4Project Mgmt
Registry Services(EPM)
1.0.1.5Site registry
Services (SBIR)
1.0.1.6Financial Registry Services
1.0.3Sponsored research Services
1.0.3.1Sponsored research
(Opportunities)
1.0.3.2Sponsored research
(Awarded)
1.0.3.3Sponsored Research
(publications)
1.0.3.4Sponsored research Ancillary (Patent)
1.0.5.1FDA CDISC submission
1.0.4.4Imaging
Resource Services
1.0.6.5User Support
Services
• Buisness Process Owner – authorized to create projects within the RPR
• Data Stewardship – responsible to ensure data accuracy
• Enterprise Architect -identify services and systems to be integrated, automated or manual
• Central Administration – accountable to enforce uniform business practice
• Governance – data security and access control
• Change management – best methods for introducing new system and gaining acceptance.
Outstanding Issues
HSDB Progress• Administrative Data elements• Harmonization with BRIDG• ClinicalTrials.gov mapping• Methods and approach• Internal inventory data elements /systems • Prioritization and mapping• Sponsor & Funding - $$$$
Prototype - Screen draftDRAFT
CHAVI (Center for HIV-AIDS Vaccine Immunology) DCRI (Duke Clinical Research Institute), IGSP (Institute for Genome Sciences and Policy) Comprehensive Cancer Center, Center for Chemical Biology, Center for the Study of Aging and Human Development Human Vaccine Institute Center for Microbial Pathogenesis Center for the Study of Medical Ethics and Humanities Stedman Nutrition Center Duke-UNC Comprehensive Sickle Cell Center Duke-UNC Brain Imaging and Analysis Center
Research Project Registry Entry Screen
Principal Investigator:
Other team members:
Brief Description:
Is this project associated with any of the following Institutes or Centers? (check as many as apply)
Program Project or Center – MAIN APPLICATION Basic research (discovery) T1 Translational research (bench to bedside) Clinical
ConsentingNon-ConsentingClinical pilot or feasibility studyClinical trialHealth services or policy researchOutcomes research (economic or patient-reported outcomes)Epidemiologic researchCommunity-engaged research (T2 translation)
Research infrastructure development Other
Which of the following BEST characterizes your planned research? (check only one)
Attach documents:
Unique ID(automatically generated)
Short Title:
Will this project require any of the following approvals? (check as many as apply)
IRB IACUC IBS
IND (sponsor _______) IDE (sponsor _______)
Tags/Keywords:
Will this project require an IND or IDE?
Potential data fieldsData Element Origin (system)
Unique ID Research Project Registry (RPR)
Project title RPR or SPS
IRB number eIRB
Most recent IRB approval date eIRB
IACUC number IACUC
Most recent IACUC approval date IACUC
SPS number/s SPS
Industry contract tracking number OCRC KSS system
eResearch number eResearch (Velos)
Fund code/s SAP/R3
Project start date SPS
Projected or actual end date SPS
Type of research RPR
Institute or Center affiliation RPR
Principal Investigator RPR
PI Department SPS
Owning org SPS
Collaborators RPR
Search Tags RPR
Parent Project RPR
Prototype Report Example
Unique ID Project Name (short) PI PI Dept Type of Research Owning Org SPS IRB IACUC IBS SAP/R3 Center Affiliation1234 CVD and diabetes Joann Smith Med CT Phase III DCRI In process In process NA NA DTMI1235 QOL in elderly John Taylor Surgery Outcomes Surgery Approved Approved NA NA 303-1143 Aging Center1236 Genome sequence of sheep Brian Adams Biochem Basic Biochem Completed NA Completed NA Completed1237 Acupuncture for smoking Meg Ryan Med Clinical Pilot Med In process Approved NA NA In process Integrative Med1238 Beta alpha beta Brad Pitt Surgery Basic Surgery Approved NA Approved NA In process1239 Ovarian cancer in mice Tom Hanks Med T1 Med In process NA In process NA In process Cancer Center1240 Cell processing facility Jude Law Peds Infrastructure IGSP Approved Approved NA NA In process IGSP1241 Lung health and asbestos in NC Annette Benning Med T2 Med NA NA DTMI1242 Yawning and sleep Jennifer Lopez Psych Clinical Pilot Psych Completed Completed NA NA Completed1243 Transportation for kids to doctor Robin Williams Peds Health Svcs Peds Approved In process NA NA In process1244 Epidemiology of influenza Dan Savage Med Epidemiology Med In process NA NA1245 Alpha beta alpha Brad Pitt Surgery Basic Surgery Approved NA In process In process In process1246 Ear infections in peds Roy Williams Peds CT Phase II Peds NA In process NA NA In process1247 Decision making in cancer Lance Armstrong Med Health Svcs Med Approved Approved NA NA 303-1234 Cancer Center
EXAMPLE Report from Research Project Registry
Big Ship !
