The Veterans Administration IRIS Database for Research

Management

Cornelius H. Lam, MD, PhD, Robert McGovern, MD, Eric Hansen, PhD

Department of Neurosurgery, University of Minnesota, Minneapolis, MN

Minneapolis VA Health Care System, Specialty Care Service Line

Financial and Business Relation to PresentationThere is no financial or business association to any businesses discussed in this talk among any of the presenters.

Companies mentioned in talk includes:

iMedRIS Data Corporation

EnterpriseWeb LLC

Zaiga Technologies Inc

Microsoft

Apple

RedHat Linux

Why Electronic Management of Research paperwork important

• Needs safe and permanent repository of paperwork

• Synchronize policy-controlled activities across collaborators, compliance officers and sponsors

• Consistent interface for researchers and research administrators from local to national levels

• Rapid retrieval mechanisms for oversight agencies and committees

How this is done at other institutions

• University of Minnesota• $948 million research expenditure top 25 in US, 37 in world

• Office of the Vice President for Research

• IACUC – ePROTOCOL

• IRB - ETHOS

$ millions

12.1

10.210.8

11.610.4

12.4

9.3

7.9

5.84.6

1.9 2.1 1.7 1.2 0.29

30.4

26.8 26.9

23.7

21.8

0

5

10

15

20

25

30

35

2013 2014 2015 2016 2017VA NIH Pharma total

Notes:

The “total” includes other funding besides NIH, VA, and pharma (e.g. DoD, foundations)

Research funding has steadily declined over

last 5 years , including a 63% decrease in NIH

funding

MVAHCS Research Expenditures by SourceFY13-FY17

What the VA has done in the past

• Research Compliance Management System (RCMS) –Zaiga Technology• Database program specifically for research compliance

• Developed agendas for standing research meetings and generates minutes and outcome letters

• Track training of research personnel, expiration dates, protocols, committee, submissions, credentialing, licensing, qualifications, animals, etc.

• Written specifically for licensure for the Research Services at the Department of Veterans Affairs Medical Centers

• To help with management of ORD (Office of Research and Development), ORO (Office of Research Oversight), and state and local authorities for compliance

• Up to version 8 and Currently divested and slated to be unapproved Q3 2019

• Only use is with special permission (Strategic Technology Alignment request)

• Developed software for the US Department of Veterans Affairs

• Research focused programs that facilitate reviews, compliance, protocol management and reporting

IMedRIS

• Began in 2001

• Currently situated in Redlands, California

• Optimize research administration

• Research information software and development tools• Study Assistant (1st module)

• Over 200 clients (institutions)

• Modules for handling committees, boards, and workflows

iRis description

• Software composed of a set of scalable research compliance applications

• Communicates through a common database portal

• Assists research to comply with federal regulations

Benefits of utilizing iRIS to conduct VA research include:

• Already used successfully by several VA divisions

• The simplicity of “scalable framework application”

• Allows for rapid support existing user base and research projects

• Powerful analytical capabilities/facilitate access to data and reports

What IRIS Isn’t for the VA

• Does not manage the grant paperwork – own grant system

• Does not manage finances of the project – own accounting system

• What IRIS IS• Handles procedural protocols

• IACUCs and IRBs

• SRS – Subcommittee on Research Safety approvals

• R&D committee – approves research for appropriateness for the VA

• Insure correct workflow for paperwork to appropriate committees

• Check for approval

• Submit amendments and annual reviews

• Responses to concerns

• Unanticipated problem reports

Technical Aspects

• Data is stored in a Microsoft Structured Query Language (SQL) Server data base and an Oracle Database

• Its use has to comply with all VA policies and standards including• VA Handbooks 6102 and 6500• Directives 6004,6513, 6517• National Institute of Standards and Technology (NIST) standards• Federal Information Processing Standards (FIPS)• Data sensitivity requirements

• Current supported operating systems• macOS• Red Hat Enterprise Linux• Windows Client• Windows Server

Data Sensitivity requirements

• Information security Officer (ISO)

• Facility Chief Information Officer (CIO)

• Local Office of Information and Technology (OI&T) representative

• Software testing required in desktop, testing and production environments

Upgrade Rate

• Roughly new version every 1-2 years

• Older version is divested or unapproved

• Version 10.03 and 10.03.x currently approved with constraints

• 10.03.x approved with constraints until Q2 2020

• 11.x until Q4 2020

How iRis for the VA is differentiated from others• iRIS Framework – remote data

• Veterans Affairs

• iRIS Enterprise and Lite

https://www.imedris.com/veterans-affairshttps://www.imedris.com/iris-framework-1

Project Implementation

• Has a designated iRIS administrator specific to the VA. Supplemental training materials includes: training videos, editable user manuals, patch notes, and release notes.

• Able to build custom forms, letters, agendas, and notifications

• Can create your project plan

• Imports legacy data

• Configures CITI training records

Modules utilized by the VA

• IRB Assistant

• IACUC Assistant

• IBC Assistant

• Pre-Award Assistant

• COI Assistant

• ARC Assistant

• SRB Assistant

• Radiation Safety Assistant

• Time Card Assistant

• Study Assistant

• Feasibility Assistant

• Flex Board Assistant

• IRB

• IACUC

• Conflict of Interest

• IBC (institutional biosafety committee)

• Study Review Board (SRB)

Institutional Animal Care and Use Committee Module

• Streamline forms for regulatory and ethical considerations

• Customized routing processes (ie. Veterinarian)

• Online Help aid the research team in filling out forms

• Review process that documents all study approvals, procedures and amendments

Institutional Review Board Module

• Enables researcher to file electronically directly to the review board for triage and accuracy and review

• Rapid cycling of correction process

• System built on best practice in accordance with AHRP (Accreditation of Human Research Protection)

• Smart form includes session for validation and logic branching

• Work form designer used to customize routing process (i.e. radiation)

Sample of what IRB may seeWhat the board sees after a study submission:

1. Project and reference numbers2. PI’s3. Type of Submission (i.e. Add or Remove Key Personnel)4. Date of submission5. Stage of Review Process6. Assigned Analysts and Reviewers

The board is able to open each document attached by the study side and return with comments

Conflict of Interest Module

• Can be configured to examine different types of research applications

• Licensing and intellectual property

• Pharmacy Decisions

• Investments

• Fundraising Decisions

• Contracting

• Annual Reporting

• The IBC module is ideal for researchers and committees responsible for ensuring that research involving rDNA and biological agents remains compliant with NIH guidelines

• system is built on best practice for government research institutions

• The IBC module can be used as a stand alone module or integrated into a suite of complementary modules such as RSB, IACUC, IRB, COI, etc.

Institutional Biosafety Committee Module (IBC)

Scientific Review Board Module

• The iMedRIS SRB automates the review process by integrating site activities directly with review board(s)

• The Workflow Designer tool customizes routing processes that are specific to VA requirements

• Workflow functions include the ability to use answers from questions on the forms to route the submission down directed paths for review (i.e. Safety of research protocols)

• Sends notifications and updates directly to key study personnel

To request a new accountgo to the iRIS homepage andselect “Request new account”

Under my studies you can view the status of each protocol

To submit a form for an approved Study:From your iRIS home page, click “My Studies” to see a list of all your studies.

On the line with the correct study, click on “Click to Open”

Click on the form you would like to complete (i.e. Amendment Form)

For an amendment to a protocol: describe your changes and continue through the form

Take home

• The research endeavors of the VA at a national and local level requires electronic management of record keeping

• The current system permits compliance of local research offices to national demands for transparency and ease of access

• Regulatory agencies and can be effectively receive response