Optimizing Data Quality and Patient Safety with EDC Integration

Transcription

1 Optimizing Data Quality and Patient Safety with EDC Integration March 2012 Gwen Alofaituli Sale, MPH Lead Business Systems Analyst, EDC Christopher Lanning, MS Sr. Scientific Developer, EDC Lawrence Love Sr. Scientific Developer, Presentation Roadmap Topic Discussion Leader Time City of Hope Gwen 10min Mission Services Integration Subject Enrollment and On/Off Therapeutic Protocol Key benefits Streamlining Clinical Trials Registration Process Using Medidata Rave web services Patient registration integration Off treatment integration Chris 10min Safety Monitoring for Patients on Therapeutic Protocols data to the data to the Questions & Answers Lawrence Gwen, Chris, Lawrence 10min 5min 1

2 City of Hope National Comprehensive Cancer Center City of Hope has a long-standing commitment to caring for the entire person, as reflected in its credo: There is no profit in curing the body, if in the process, we destroy the soul.' It s what makes City of Hope unique and what makes it the right place for this kind of center." - Sheri Biller (CRIC) Mission: Apply the science of information management to enable the effective and efficient execution of Clinical Research: Clinical trials Observational and outcomes research 2

3 CRIC Services Service Description Key Systems / Projects Clinical Trials Management Systems () Electronic Data Capture (EDC) Clinical Research Decision Support Provide informatics solutions to manage the planning, execution, and reporting of clinical trials, such as protocol authoring and subject enrollment Provide electronic data capture (EDC) systems with electronic case report forms (ecrfs) or computerscannable CRFs to capture study data, such as adverse events and tumor response Transform data to decisions using business intelligence tools to report and analyze study-related data Evaluation Project MIDAS (legacy ) Clinical Trials Online (CTOL) Medidata Rave EDC InTeleScans (built on Teleforms technology) Clinical Research Portal SAS InTeleScan Work Bench Clinical Trials Online (CTOL) Business Objects (Rave) Automated Lab-Based Adverse Event Grader Subject Enrollment: Paper-Based Process Subject is Enrolled CRA Enters Subject Data in CRA Completes Case Report Forms (CRF) Data Entry Enters Research Data in 3

4 Subject Enrollment: Electronic Process Subject is Enrolled CRA Enters Subject Data in CRA Completes Electronic Case Report Forms (ecrf) EDC City of Hope Patients 4

5 Patient On/Off Therapeutic Protocol Subject is On Treatment CRA Completes Off-Treatment Data in EDC EDC Key Benefits Benefit Patient Safety Timely Data Collection Data Synchronization Data Validation Business Impact for City of Hope Allows the Therapeutic Protocol notification in the to be updated in a timely manner Reduces lag time between registration in and adding a patient in the EDC system Enables more timely data collection Ensures vital patient information (e.g. Patient ID, Study ID, Treatment Arm, off-treatment date, etc.) is synchronized in and the EDC system Eliminates i redundant d data entry and improves data quality Upfront data validation at the point of data entry Real-time success/failure notification 5

6 Midas our Web-based front-end, built using ASP.Net MS SQL Server back-end Uses SOAP and WSDL-based interfaces Based on a legacy MS-DOS program Medidata Rave EDC Web based browser neutral front-end 21 CFR Part 11 compliant system System housed in Houston Texas and managed by Medidata Integration with other systems using web services 6

7 EDC - Rave Web Services (RWS) : Inbound Web services uses RESTful architecture over HTTPS Conforms to CDISC Operational Data Model (ODM) 1.3 standard XML document consisting of a hierarchical tree of elements and attributes with some vendor extensions Uses different URLs to access different functions (i.e. lists of studies, drafts, versions s and other metadata, as well as access to study data) Rave Web Services (RWS): Outbound Integrates into Rave using Custom Functions Supports HTTP GET and POST Error reporting Secure data transfer using SSL 7

8 Overview of to EDC Patient Registration Integration EDC- Integration WS RWS Inbound EDC End user enters registration data into OnTime (Error Tracking) Protocols & Site codes Patient Registration Integration to EDC All registration data entered or updated in only Mapping code lists for protocols, sites and treatment arms Two methods: IsEDCStudy and AddUpdateRegistration All errors are captured and logged into ontime error tracking system username captured and passed to EDC to maintain audit trail Security token (guid) passed from, and verified by -EDC Integration Web Service 8

9 Overview of EDC to Off Treatment Integration EDC Medidata Rave Custom Function Web Service via User enters off-treatment data into EDC OnTime (Error Tracking) Off Treatment Integration All off treatment information entered into EDC only When off treatment record saved, custom function passes data web service All errors captured in ontime error tracking system EDC user name passed to for audit tracking Security token passed and verified between EDC and Patient identification is further verified by Date of Birth and Protocol Identifier to ensure the correct patient record is being updated. 9

10 Allscripts Uses interface messages to communicate between health systems Includes ADT (Admit, Discharge, and Transfer) messages Getting Data into the ADT Repository Patient data is entered in the. 10

11 Getting Data into the Patient data is entered in the. Data is stored in the database. ADT Repository Getting Data into the Pushes messages in real-time. receives the messages. ADT Repository 11

12 Getting Data into the A script runs every 10 minutes to parse the messages and store them in a relational database. ADT Repository Getting Data into the Gateway Patient Therapeutic Flag is updated in the. 12

13 Getting Data into the Gateway Patient Therapeutic Flag is updated d in the. Patient Therapeutic Flag is written to an interface table. Getting Data into the For new patients, a database job runs every 10 minutes to pull the records from the ADT Repository and insert into the database. ADT Repository For existing patients, a database job runs every night to pull data from the ADT Repository and updates the database. 13

14 Getting Data into the Gateway pulls unprocessed Patient Therapeutic Flag data, processes the data, and marks as processed. Getting Data into the Gateway Sends Patient Therapeutic Flag messages to Gateway 14

15 Getting Data into the Gateway receives messages and updates the Patient Therapeutic Flag in Gateway Thank You! Sponsors Adina Londrc, MD, MPH Director, Clinical Research Information Services Gabe Peterson, MBA, PMP Director, Clinical Research Informatics Project Team Gwen Alofaituli Sale, Project Manager Chris Lanning, Sr. Scientific Programmer Lawrence Love, Sr. Scientific Programmer Gary Cumming, Sr. Scientific Programmer Jennifer Boesen, Business Systems Analyst Eric Huang, Database Administrator 15

16 Questions Gwen Alofaituli Sale Chris Lanning Lawrence Love HOPE (4673) 16