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OnCore Clinical Trial Management Software

OnCore Clinical Trial Management Software

OnCore is the Clinical Trial Management Software (CTMS) used by the Medical College of Wisconsin. The Cancer Center CTO has been using OnCore since 2011. OnCore is now available Enterprise-wide for all departments/divisions’ study management needs. The CTO is responsible for implementation, training, access, troubleshooting, and continued support for non-cancer departments/divisions wishing to use OnCore at MCW.

OnCore use is currently optional for all non-cancer trails, but there are great benefits of a centralized database of clinical trial information to help support trial execution in an efficient and compliant manner.

Features

  • Protocol and subject life cycle management
  • Subject safety management
  • Protocol and subject calendar management
  • Study budget preparation and financial management
  • Staff effort tracking
  • Study information portal
  • Create and maintain patient registries
  • Custom reports

OnCore Exploratory Form

If you are interested in pursuing OnCore implementation for your Department/Division, please complete the following brief questionnaire and return it to CTO1@mcw.edu:

59 KBOnCore Exploratory Questionnaire_v1.0

Protocol Entry by the MCW CTO

Please complete the following form PRIOR to entering a new protocol into OnCore and send it to CTO1@mcw.edu. You will be notified within 2 business days your protocol has been created in OnCore along with the name and any further instruction.

58 KBOnCore Protocol Shell

OnCore Guides

The OnCore help guides and standards are arranged by functionality. They contain detailed how-to instructions and requirements.

General

Communication Memos

View the Communication Memos on the Office of Research’s website for MCW-wide standards related to OnCore.

PC Console

Field Definitions

This document provides field definitions for the PC Console in addition to standard data entry guidelines for MCW’s General library. The Table of Content’s field list hyperlinks to the corresponding definition.

679 KBPC Console Field Definitions_v2.0 October 2018
Regulatory

OnCore – e-Bridge Mapping

If an IRB submission already exists, this guide maps fields in OnCore’s PC Console to the corresponding question# in eBridge.

89 KBOnCore_eBridge Mapping.pdf

IRB Review Tab Requirements

The minimum documents to be uploaded and IRB reviews to be recorded in the IRB Tab. In addition, detailed diagrams illustrate Tab completion

507 KBIRB Review Tab Requirements
CRA/Subject Console

Enrolling Subjects

Provides an overview of the Subject Console including:

  • Adding a subject to a protocol using the OnCore-EPIC interface
  • Recording a Consent
  • Entering milestone dates (e.g., On Study, On Treatment, Off Treatment, etc.)
  • Adding subject documents
531 KBEnrolling Subjects
Calendars

Checking in a subject visit using a subject calendar and scheduling Planned visits

938 KBSubject Calendars

Add an additional procedure to a visit or record an additional unplanned visit

617 KBAdd an Additional Visit / Procedure
Electronic Case Report Forms (eCRFs)

Enter data into eCRFs via the Forms by Status tab with instructions for GRID forms (adverse events, con meds, etc)

523 KBElectronic Case Report Forms (eCRFs)

Add an additional form(s) when a procedure occurs multiple times during a visit.

662 KBAdd an Additional Form

NIH Funding Acknowledgment: Important Reminder – Please acknowledge the NIH when publishing papers, patents, projects, and presentations resulting from the use of CTSI resources by including the NIH Funding Acknowledgement.

PARTNERS

VersitiChildren's Hospital of WisconsinVA Medical CenterMarquette UniversityMSOEUWM