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OHSU’s Electronic Clinical Research Management System (eCRIS) Coffee Talk November 14, 2013

OHSU’s Electronic Clinical Research Management System (eCRIS) Coffee Talk November 14, 2013. Electronic Clinical Research Information System ( eCRIS ).

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OHSU’s Electronic Clinical Research Management System (eCRIS) Coffee Talk November 14, 2013

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  1. OHSU’s Electronic Clinical Research Management System (eCRIS) Coffee TalkNovember 14, 2013

  2. Electronic Clinical Research Information System (eCRIS) • An institution-wide computer application for the budgeting, financial management, contracting, and study management, including subject tracking, regulatory reporting and document management, of OHSU clinical research studies • Vendor: Huron/ClickCommerce (same as eIRB) • Interfaces: eIRB, OGA, and Epic

  3. eCRIS Benefits • More efficient processes (study start-up, receivables management, etc.) • Increased/easier compliance (billing, IRB, study conduct) • More accurate budgets • Better financial tracking • Tools for study management • Easier IRB reporting • Increased cost recovery/fewer account deficits • Better management and oversight of resources • Flexible and comprehensive reporting and forecasting • Improved ability to understand OHSU’s clinical research portfolio

  4. Studies Required to Use eCRIS • Studies required to use eCRIS • All studies prospectively consenting OHSU subjects • All funding sources (and unfunded) • Some exceptions • Single visit if no clinical services & not industry sponsored • Existing clinical samples • No OHSU subjects (consent by OHSU staff) • Other studies may use eCRIS, but are not required • Can use eCRIS to manage external sites, but not required

  5. eCRIS Adoption Schedule

  6. eCRIS Mandatory • After 1/13/14: • For studies consenting subjects with an OHSU consent form • Will need to push “Create of update eCRIS study” activity in eIRB prior to submitting study to IRB • For exceptions, will be process created to allow

  7. eCRIS Access: Recommended Training Prerequisites • Clinical Research Coordinator Workshop • Next class January 15 & 16, 2014 • www.octri.org, Education & Training for Study Coordinators • Clinical Trials Award Administration 1 & 2 • Next classes: • CT 1: TBD (being scheduled in 2/14) • CT 2: 11/19/13 • Research Administration Training & Education (RATE): http://www.ohsu.edu/xd/research/administration/training-and-education-rate/

  8. eCRIS Access & Required Training • Big Brain online training module • Different tracks for research staff and PIs • https://bigbrain.ohsu.edu/ • Research staff • Required in person training • Approximately 2 hours • Will be contacted after take the online module to schedule • If you do not have eIRB access • Request an eIRB and eCRIS account • Accessible from the eIRB login page • Access eCRIS: ecris.ohsu.edu

  9. eCRIS Study Financial Management • Generate all invoices for the study, if required using data entered in payment terms smartforms • Invoices automatically forwarded to SPA • SPA reconciles invoices with payments in OGA • Payment information imported into eCRIS • Invoices generated matched with OGA payment information • Automatic payments (those not requiring an invoice) imported into eCRIS and activity available to reconcile payment with work performed and tracked in eCRIS

  10. eCRIS Ongoing Studies • Ongoing studies = IRB approved study • Can use eCRIS to: • Track subjects • Manage finances (if industry sponsored) • Minimal information required to get study into eCRIS • Existing subjects can be bulk uploaded into eCRIS • Study staff enters information onto an excel template • Sends the template to ITG • ITG uploads the data into eCRIS lets the study team know when complete (~1 week) • Can enter additional information if additional functionality desired • Visit schedule: • If want to enter past visit information • If want to project future subject visits • Budget: If industry sponsored and want to generate invoices and/or track financial information • Ongoing studies process available in the eCRIS manual and template will be available on the eCRIS website • Specific ongoing studies training will be available

  11. eCRIS Demo • eCRIS study financial management • eCRIS ongoing studies

  12. Questions? • Misha Lenz, eCRIS project manager • Darlene Kitterman, eCRIS content specialist • Kristin Stiller, eCRIS trainer • http://www.ohsu.edu/crms • eCRIS support: eCRISSupport@ohsu.edu

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