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eResearch Suite A comprehensive electronic platform for

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1 eResearch Suite A comprehensive electronic platform for
consenting and participant data collection Jason Kadrmas AHC-IS - Research Development Services Manager Melissa Mueller CTSI Recruitment Service Manager September 9, 2016

2 Overview Overview of StudyFinder Overview of eResearch Suite
Questions and feedback from the group Are other institutions working on something similar? Interest? General feedback? We introduced this tool to MARCH representatives on the August 1 MARCH call. Feedback was positive, with some good suggestions for future direction. Wanted to present this to the larger MARCH group.

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4 Introduction to StudyFinder
What is it? studyfinder.umn.edu Displays information on recruiting trials Responsive - Mobile/Kiosk Friendly Open source Themeable to allow for use by other institutions VCU, PSU, UTSW Potential to interface with multiple data sources Refreshes data nightly How does it relate to eResearch Suite

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6 Search by category Refine search within a category

7 Search results are laid out in study snapshots, allowing users to quickly view the basics of several studies.

8 Within each study snapshot, the user can take several actions:
- the study information to themselves (or a friend/family) - the study team - See more information about the study, clinicaltrials.gov record

9 StudyFinder adopted by other institutions
UTSW

10 eResearch Suite

11 eResearch Suite What? Web-based platform for consenting and data collection Why? Need to e-consent patients in an easy, streamlined, consistent way Modeled after Apple ResearchKit but cross platform and web-based Relation to StudyFinder Limitations of Apple Research Kit: Builder interface for participant data collection (surveys, etc) - iPhone only, no backend solution, app developer needed

12 eResearch use Designed to take participants from browsing for studies, to preliminary screening, through consent, and on to study data collection Studies can use entire workflow or select pieces of the workflow, depending on study design and study population Full workflow: registry studies, adult low-risk studies, non-interventional Current pilot: MBSR study for cardiac patients using e-consent, participant surveys added randomization, added QR codes expanded to use eResearch for internal data tracking and study management 100% have e-consented, 80% consented remotely MBSR = Mindfulness Based Stress Reduction Exploring pilot for cardiac patient registry

13 eResearch Suite demo Electronic screen, consent, quiz/survey
Build entire informed consent process Builder interface for participant data collection (surveys, etc) eResearch Flows: Participant Researcher administration Turn this into screenshots with notes/captions

14 Initial Screening Questions Link from StudyFinder to eResearch
- eResearch can be used used with other clinical trials websites or can be used as a standalone application.

15 Review consent form and register with eResearch
When user clicks “View Consent Form” button a PDF of the full consent will be displayed.

16 Check your understanding of consent
User can view consent again if needed User must pass the quiz before being able to sign the consent

17 Consent Form Open sourced components - 7k download.

18 Participant interface & activities

19 Researcher interface: Building consents & surveys

20 Researcher interface: Participant list

21 Investment StudyFinder development began 2013
eResearch development began in 2015 eResearch developed with two staff at approx. 10% FTE eResearch use at other institutions Minimal server requirements - linux based server Database - Oracle, Postgres, MySQL, SQL Server 1 technical 10% FTE for ~ 1 month.

22 Questions/Feedback General questions and feedback
Is this worth moving forward with? Is there interest/need in using something like this at your institution? Is anyone else doing something like this? If so, who and what?

23 Thanks! Jason Kadrmas: kadrm002@umn.edu
Melissa Mueller: StudyFinder:


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