Information Technology Update

Transcription

1 CIBMTR Information Technology Update Huoy-Jii Khoo IT Director, CIBMTR Colleen O Neill, PMP Program Manager, Bioinformatics CIBMTR/NMDP Clinical i l Research Professionals Data Management Conference November 4-5, 2009 Hilton Minneapolis Hotel, Minneapolis, MN New08_1.ppt

2 Objective Overview of Our Commitment Data Integration & Quality Information Sharing and Dissemination Online Collaboration FN2 / ANGIS Update

3 Overview CIBMTR Leadership Commitment to Improve Process and Increase Efficiency Engaged a FN2 project review Look for opportunities to improve effectiveness, both internal and external Shown results in the past year; We want this to continue Since, Broaden our Scope from FN2 to Other Areas Change Does Take Time

4 CIBMTR IT Goals (Flash from the past, past year presentation) Transform CIBMTR Information Technology Raise customer satisfaction Deliver-On-Time/Target (DOT) Improve Structure/Process Proactive Promote Communication, Collaboration and Be Transparent Establish an Identity that Represents Excellence Utilize, instead of Enslaved by Technology

5 Data Integration & Quality CIBMTR Data Pipeline/Network Integration Current State: CIBMTR Observational Database is not fully integrated at this time Challenges: Multiple data sources and systems Continue to identify and fix data issues as we try to consolidate and integrate them (ie. Center Volume Report issues, managing Transplant Center Personnel information) Resolutions: Immediate CIBMTR s communication: Request for data verification and confirmation; error correction. Long-term New Validation Service for all systems to share and utilize (defer to FN2 update)

6 Current CIBMTR Data Pipeline/Network

7 Data Quality Data Integration is Straight Forward, Maintaining the Data Quality is a Whole New Ball Game! Data Quality Data Accuracy and Consistency Validation and Verification Have to Execute and Maintain at All Levels

8 Information Sharing and Dissemination CIBMTR Web Presence Project Developing New and Integrating Existing CIBMTR web sites/resources public web site redesign CIBMTR Web Portal Custom web application site CIBMTR Collaborative Site Promote Collaborate CIBMTR secure web-base network drive CIBMTR Single Sign-On (SSO) Credential Implement an integrated security framework that incorporate Transplant Center s personnel job roles Decentralize the CIBMTR web content management and publishing Improve CIBMTR Web Search Functionality

9 Online Collaboration CIBMTR SharePoint Collaboration Site Used by CIBMTR internal offices Collaboration and information sharing Cross team integration/training Will be pushed to CIBMTR s 19 Worldwide Working Committee for future Study Collaboration How Can This CRP/DM Group and Transplant Centers Take Advantages of this resource?

10 Other CIBMTR IT Activities for Transplant Centers DBtC Data Back to Centers project Immediate HCT centers data needs Not replacing AGNIS Alternate way (intermediary) for HCT centers to retrieve/download subset of submitted data through FormsNet 2 FN2 CVR Center Volume Report Mechanism to electronically deliver and track Transplant Centers Activity Summary Report

11 Other CIBMTR IT Activities for Transplant Centers GCM Global Contact Management Consolidate and integrate t CIBMTR s Transplant Centers and Contacts Management Systems CIBMTR Observational DB Management System project (Multiple Phases) CIBMTR internal use; to manage all Observational Research Data

12 AGNIS & DBtC Comparison AGNIS DBtC Programming Yes No Access to data Automated/programmable Manual download Data source FormsNet 2 CIBMTR Observational Research Database Data dictionary Curated cadsr dictionary SAS save-set dictionary** Scope of data Current version (1.2) supports preted (2400), postted (2450), IDM (2004), HLA (2005), and Death (2900) forms. Upcoming release will support PDF versions 1 and 2 of these forms (where applicable) and the Infusion (2006) form. PreTED (2400), PostTED (2450), Selective TED (2455), with more to come. Transaction Submit, download Download only Data format RAW Processed, accepted by CIBMTR Observational Research Database Target Center s w/ IT Support Without IT Support ** SAS save-set data refers to the data format used in Milwaukee for data analysis

13 CIBMTR IT Update FormsNet2 / AGNIS Colleen O Neill, PMP Program Manager, Bioinformatics

14 FormsNet2 & AGNIS Update Achievements Current Status t Challenges Future Plans

15 Recent Achievements Introduced new project disciplines Adopted the new NMDP SDLC approach for project implementation Communication, status and planning are transparent Adopted standard processes for documentation, requirements solicitation, documentation, management oversight, signoff, tech review, QA and UAT Aimed at managing increasing system complexity and integration requirements with application development Establishes a process for sustainable growth Helps to insure quality and efficiency Helps to prevent ent production rollbacks, missed deadlines, missed requirements and features

16 Recent Achievements Automated Regression Testing Follows NMDP IT QA coding standards and has passed QA Team code reviews. Excel Test cases created during application development are used as automation data spread sheets. Each Form test case (data spread sheet) had nearly rows to test. Estimation was difficult because of manual effort. With automation, this test has been reduced to 2 hours. For R2.9 (Donor) Release, each form was re-tested 3 times using automation. Automation has reduced resource time. 26 Forms have been executed on 3 Test machines for 2 days which saved 3 resource s time (for manual execution). Three cycles initiated for some build releases increasing the testing coverage.

17 Recent Achievements August: NMDP Donor Data Collection Incorporation of the Donor Forms into the FormsNet2 application. Twenty-six forms incorporated into FormsNet2 SIP interface to trigger Donor forms to become due Donor Reporting (based on existing reports, including CPI) Donor Form triggered Adverse Events and Protocol Deviations handling Donor Tools Upgraded FormsNet2 Security Audit Trail capabilities

18 Current Status November Updates to Recipient Data Collection: Twenty-six new and updated forms into FormsNet2 Modifications needed to support the summer, 2009 release of AGNIS New rules for KGF and Busulfan studies Correct conditions where inserts are being made due incorrectly Correct conditions where forms are made due when a change is made after form 2900 is entered Seven non-override validations requested for research. Allow viewing of comments on fuzzy matches Clinical Trials Data Collection: The Pediatric Blood and Marrow Transplant Consortium (PBMTC) has asked CIBMTR/NMDP to build clinical trials infrastructure for a clinical trials management system The CIBMTR/NMDP, working with University of Utah, was awarded a 5-year NIH grant to study related donor safety. The trial will begin enrolling subjects in late Fall 2009

19 Challenges Legacy Data Migration Recipient data used for research and reporting purposes are currently in three primary databases; NMDP legacy database, CIBMTR legacy database and FormsNet database. These data need to be migrated to one database for access for research and reporting purposes. NMDP legacy data must be migrated to the FormsNet 2 database. From there, NMDP legacy and FormsNet 2 data can be electronically transferred to the Milwaukee legacy database.

20 FY10 Priorities: Objectives and Actions FormsNet & AGNIS are keys to our success Connect 10 centers to AGNIS in FY10 Be leading edge in technology to deliver solutions Improve connectivity between MSP & MKE Data quality is key. It has to be current, complete & accurate Validation issues at entry and validation between FN2 / Research databases are resolved Data integration and delivery must meet stakeholders needs Reporting and mining/warehousing solutions are delivered Rebuild goodwill with stakeholders Continuous high quality releases for FN2 Module enhancements and support are delivered with confidence

21 FY10 Plans Forms and Validation Engine Re-Design More Extensible (ability to add new functions very easily) Separation of Donor, Recipient and Clinical Trials release interdependencies within FN 2 Separate AGNIS from code dependencies Enhance data quality, validation, user experience and reduce project life cycle Reduce release interdependence during DEV and UAT phases Quicker turnaround on future enhancements. Both engines will be much easier to update and understand by DEV, QA, and UAT Creation of Detailed Specifications for both new engines Allows for better production support Allow for new developers to begin developing much easily Creation of simple FN 2 Infrastructure Model Remove web frames usage in FN2 All save and get functions would have their own Web Services Functions such as Date & Time would be supported and/or easy to add in the future Would allow for end-users to Save at any point of form creation or editing

22 FY10 Plans Data Integration Integrate FormsNet2 data (legacy and SCTOD) with NMDP operational data (SIP), research repository specimen data, genetic testing data on these samples (IPR), and legacy data in the CIBMTR research database. Requires the development of a data model and set of ETL processes for integrating these data from their various original sources. In addition, a series of data marts will be developed and populated based on the reporting requirements for CIBMTR and the SCTOD The legacy donor data will also need to be migrated to the FormsNet2 database, a horizontal data mart created so data can be more readily extracted, views created so the CRC team can view data through InfoMaker. Requires thorough quality assurance procedures. Clinical Trails Additional functionality New trials begin Auditing and monitoring Enable CIBMTR staff to go to one application to access all required tools for implementing a center audit, regardless of center type. Conduct a paperless audit, accessing and correcting audited data fields on their laptops.

23 AGNIS AGNIS secure communication using standardized data elements for the HSCT community Initial version AGNIS 2.0 version AGNIS & Curation Plans Support for Transplant Centers

24 AGNIS 2.0 Retrieval Ready for Transplant Center development Currently supports 3 mandated forms 2400, 2450, 2900 Remaining mandated forms in progress

25 AGNIS Plans Add additional forms New revisions i of mandated d forms Baseline and follow-up forms Disease-specific forms Coordinate with Transplant Centers doing development Third party vendors leveraging for their product development

26 Form Curation Progress 11 forms complete 15 forms in progress Plans to complete the most common disease forms: ALL, AML, AMY, APL, BC, CLL, CML, CNS, FAN, FNG, ID, LYM, MDS, MUC, MYE, NEU, TC

27 Support for Transplant Centers Weekly conference calls Updates on AGNIS status t Presentations on AGNIS development process Exchange and dialogue between centers and AGNIS staff AGNIS team can assist with access, setup, and connectivity Periodic IT Summits

28 Tools for AGNIS Development MetaData Tool Provides form information for mapping Released August 2009 Staging Client Will facilitate data submission Expected delivery early December