Completed project: Clinical Research Systems Implementation (EP Action Items 4, 61, 70)

Primary UITS contact: Therese Miller

Completed: July 1, 2016

Description: The Indiana CTSI and the Indiana University School of Medicine are investing in a number of IT systems that will support workflows and manage clinical data that are critical to the translational research enterprise (here, "translational" means the translation from "bench research to bedside"). As these systems will manage clinical data, this project is related to the "Private and sensitive data management" project. The current systems involved are:

  1. The Indiana Biobank. This system will manage information about biospecimens in the Sample Storage Facility (SSF) and associated data, including genomic data.

    Project Manager is Chris Hobbick (MMG); Executive Sponsor is Anantha Shekhar.

  2. A Clinical Trials Management System (CTMS). This system will support data about and workflows for clinical trials that the Indiana CTSI wishes to manage, and is to be integrated with IU Health care systems.

    Project Manager is Bob Davis (Biostatistics); Executive Sponsor is Richard Kovacs.

  3. A Research Registry system. This system supports the data management needs of clinical research projects, including integration of electronic health records, as well as the ability to create patient- or disease-oriented registries for national research initiatives.

    Project Lead is Therese Miller. Project Manager is Richard Meraz. Executive Sponsor is Anantha Shekhar.

The Advanced Biomedical IT Core is acting as point for UITS, and UITS systems are being used to host these applications.

Outcome: These systems will make the Indiana CTSI and research units at the IU School of Medicine more competitive, and will improve their ability to better manage clinical data in a strategic fashion to advance clinical research.

Milestones and status - Overall:

  • July 2012: Indiana CTSI tasks the Advanced Biomedical IT Core (ABITC) with project management of the Biobank and Registry systems
  • July 2012: IUSM Biostatistics tasked with project management of the CTMS, with support from the ABITC
  • July 2012: Enterprise Software and Enterprise Infrastructure recruited to strategically provide hosting services for the above systems
  • August 20, 2012: Anantha Shekhar establishes a Clinical Research Informatics Group chaired by Bill McConnell (CIO, IU Health) and Bill Tierney (CEO, Regenstrief) to develop an institutional clinical research informatics strategy
  • August 27, 2012: Indiana CTSI signs contract with Remedy Informatics to purchase and implement their Investigate platform for the Indiana Biobank
  • September 1, 2012: Implementation of Biobank system begins
  • March 28, 2013: Indiana CTSI signs contract with Remedy Informatics to purchase and implement their Mosaic platform to create research registries
  • April 1, 2013: Implementation of Registry system begins
  • February 20, 2015: Liaison Technologies buys the Remedy registry software assets and agrees to support the IU Registry system
  • July 1, 2015: Bill Barnett takes role as CRIO of Indiana CTSI and Regenstrief Institute, and these projects move into his portfolio
  • July 1, 2016: Biobank pilot completed in the first quarter of 2016. Registry system migrated to Oncore and REDCap in the second quarter of 2016. Oncore continues as an essential asset in the portfolio of the CRIO of Indiana CTSI and Regenstrief.

Milestones and status - Biobank:

  • August 30, 2012: Indiana CTSI contracts with Remedy Informatics to provide Biobanking system
  • September 27, 2012: Biobank implementation kicks off
  • October 5, 2012: Indiana Biobank and UITS/EI complete MOU for UITS hosting
  • November 2012: Development, testing, and production systems established for Biobank
  • May 2013: Biobank system approved by Compliance for HIPAA
  • June 1, 2013: Dr. Tatiana Foroud becomes Director of Indiana Biobank
  • November 1, 2014: Dr. Foroud moves Indiana Biobank to OnCore platform from Remedy platform
  • March 2015: Indiana CTSI signs letter of intent with BioStorage to develop pilot Biobank integration projects
  • March 2016: The pilot with BioStorage ended successfully, generating useful analysis of existing Biobank processes and proof-of-concept dashboards that Indiana CTSI will use in future evaluations of technology for this use case

Milestones and status - CTMS:

  • September 2012: Indiana CTSI contracts with Forte Research to provide CTMS system on the IUSM OnCore platform
  • November 2012: Virtify software suite for automated updating with ClinicalTrials.gov added to scope
  • May 2013: CTMS system approved by Compliance for HIPAA
  • May 2013: CTMS system now in production
  • May 2013: CTMS system supports 641 clinical trials
  • June 2014: IUSM ceases use of Virtify system for clinical trials reporting
  • July 1, 2015: Bill Barnett takes role as CRIO of Indiana CTSI and Regenstrief, and CTSM system management moves into his portfolio. UITS still supports the infrastructure as a service provider.

Milestones and status - Registry system:

  • October 4, 2012: Registry system requirements released to prospective vendors
  • November 26, 2012: Registry system recommendation accepted by Dr. Shekhar
  • January 2013: Ganesh Shankar forms cross-institutional committee to develop specifications for registry system
  • March 2013: Registry system purchased from Remedy Informatics. This purchase includes a separate module for Comprehensive Bone Marrow Transplant registry.
  • December 2, 2013: Comprehensive BMT system goes into production
  • February 20, 2015: Liaison Technologies begins formal support of registry system
  • October 10, 2015: Liasion Technologies provides roadmap
  • December 1, 2015: Two live projects belonging to Dr. Paczesny on Liasion Technologies platform move to REDCap
  • July 15, 2016: The Registry system is retired after the last investigators are migrated to using REDCap for data collection.

Comment process: Email Advanced Biomedical IT Core (ABITC).

Benefits:

  • Improved workflows for clinical research
  • Better management of a wide variety of clinical data in comprehensive repositories that allow cross queries
  • Ability to integrate data across previously siloed systems
  • Strategic positioning to advance clinical research
  • Support for quality studies required by HHS at IU Health

Primary client: Indiana CTSI

Project team:

  • Richard Meraz, Manager, ABITC (Research Technologies)
  • Ganesh Shankar (Research Technologies)
  • Abhijeet Malatpure (Research Technologies)
  • Bob Davis (Biostatistics, IUSM)
  • Chris Hobbick (Indiana Biobank)
  • Sophie Paczesny (IUSM Pediatrics)

Governance:

  • Anantha Shekhar, Director, Indiana CTSI
  • Bill Tierney, CEO, Regenstrief Institute
  • Bill Barnett, CRIO, Indiana CTSI and Regenstrief Institute
  • Bill McConnell, CIO, IU Health
  • Richard Kovacs, Associate Dean for Clinical Research, IUSM
  • Tatiana Foroud, Director, Indiana Biobank

This is document bcjp in the Knowledge Base.
Last modified on 2017-02-17 12:34:59.

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