OnCore Enterprise Research System University at Buffalo Office of the Vice President for Research and Economic Development Clinical Research Office (CRO) Electronic Research Administration (eRA)

Chelsea Allen OnCore CTMS Coordinator ctms@buffalo.edu Mariya Cherneva OnCore CTMS Coordinator ctms@buffalo.edu Marla Witkowski Campus Training Program Coordinator mlw9@buffalo.edu

What is the OnCore Enterprise Research System? OnCore is a Clinical Trial Management System (CTMS) that has been purchased by the University at Buffalo to support research activities and compliance which will allow for enhanced trial management: Robust reporting Enrollment tracking Subject management Financial reconciliation All major research centers are now using an online CTMS system to manage clinical trials SUNY and UB’s goal is to increase our research presence – in order to do that, we need the management and reporting capabilities that OnCore offers There is currently no effective way to collect all of the data that is being kept in various systems and binders at our research sites (pick an example from the crowd) Data is centralized – moving away from paper-based systems OnCore is the system of record – you may choose to use your current system, but OnCore will eliminate redundancy

OnCore Enterprise Research System CRA Course Objectives

Course Objectives – Part 1 Basics: Components and Navigation Log in and successfully navigate within the OnCore environment Explore toolbars, menus, and consoles Personalize the OnCore environment by bookmarking items of interest Summary Accrual Document the number of participants in a summary accrual study Enter demographic information for participants Summary Accrual is sheer numbers of participants, with minimal details. The details required may vary by study type. No individual subject management. Chart reviews – no demographics needed Basic science – no demographics needed If you are consenting an individual on a summary accrual, as a general rule we will need demographics

Course Objectives – Part 2 Subject Administration Register a subject for a study protocol, and place them On Study Manage a subject’s consent and eligibility for a study Assign staff to a subject Record Serious Adverse Events (SAEs) and Subject Deviations for a subject Subject Calendars and Visit Tracking Access and review individualized Subject Calendars Verify subject visits and enter visit details Enter procedures performed during a visit

Course Objectives – Part 2 Basics: Reporting and Searching Generate a report of planned visits for your assigned subjects Explore the My Console, a personalized view of OnCore data relevant to an individual user Protocol Administration Document safety letters, sponsor monitor visits, and audit visits

OnCore Training Materials http://www. buffalo Exercises Basics: Components and Navigation Subject Administration for CRA Subject Calendars and Visit Tracking for CRA Basics: Reporting and Searching Work Instructions

OnCore Navigation Tips Open only one session of OnCore at a time Turn off any pop-up blockers in your web browser Avoid using the Back button in your web browser Be aware of hyperlinks Utilize CTRL+ F (or ⌘+F) to find items in lists Use the Log Off link to avoid leaving subject data insecure You may come across a change password option – your password will always be the one from your UBIT account. If you try to change your password, and have three unsuccessful attempts you will be locked out of the system. If locked out, contact CTMS@buffalo.edu If you forgot your UBIT password - http://www.buffalo.edu/ubit/service-guides/accounts/your-ubitname-account/managing-your-ubitname-and-password/forgot-password.html

OnCore Training Site OnCore Live Site http://ctms-trn.buffalo.edu Log in with assigned training password(s) OnCore Live Site http://ctms.buffalo.edu Log in with UBIT User Name and Password