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

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.

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

Search by category Refine search within a category

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

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

StudyFinder adopted by other institutions UTSW

eResearch Suite

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

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

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

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.

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

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

Consent Form Open sourced components - 7k download.

Participant interface & activities

Researcher interface: Building consents & surveys

Researcher interface: Participant list

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 developer @ 10% FTE for ~ 1 month.

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?

Thanks! Jason Kadrmas: kadrm002@umn.edu Melissa Mueller: muell661@umn.edu StudyFinder: sfinder@umn.edu