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OnCore

  • For recording, managing, and reporting clinical research data

All clinical research studies conducted at Indiana University and IU Health require entry into OnCore if they include a prospective component and provider services and/or require informed consent.

To determine whether your clinical study should be entered into Oncore, view the Decision Tree.

  • OnCore Basics: Getting Started
  • Request OnCore Access

Before OnCore access can be granted, basic training in OnCore is required. Click the button on the right to get started by requesting OnCore Access & Training.

  • Workflow Documents

Subject

Protocol

  • Summary Accrual Request

Once a study is entered in OnCore, participant accruals must be recorded. Participants are typically registered in OnCore individually, but Summary Accrual can be requested under specific conditions. Summary Accrual refers to an OnCore function that reports the total number of participants enrolled in a clinical study using periodic updates. Visit the Individual Registration vs. Summary Accrual dropdown here to learn more about requesting summary accrual.

  • Training Guides
OnCore Building Blocks

Protocols are the foundation of all OnCore functionality and features. Protocol information must be entered in OnCore before building calendars, creating a protocol budget, enrolling subjects, tracking subject visits, or invoicing sponsors.

The PC Console (Protocol Coordinator Console) is the central repository for protocol information. Protocol coordinators track Protocol ID numbers, objectives, assigned staff, sponsors, participating institutions, regulatory information, investigational drug and device information, and other details of each research study.

Protocol & Subject Management

Financial Training

Quick Reference Guides

  • OnCore Frequently Asked Questions

OnCore Requirements for Multi-Site Study

What is a multi-site study?

Confidential Disclosure Agreement

What is a local affiliate?

Local affiliate sites would include Indiana University and IU Health hospitals/clinics, Roudebush VA, Eskenazi hospitals/clinics and community sites/clinics that cannot be associated with another academic medical center.

If IU is the lead institution of a multi-site study, what accrual should be included?

If IU is leading the multi-site study, accrual from all sites should be included.

Accrual numbers should be listed under the appropriate enrollment sites within OnCore.

If IU is not the lead institution of a multi-site study, what accrual should be included?

If IU is only participating in the multi-site study, only accrual from IU and its local affiliates should be included.

If IU is the lead institution for a study and they use sub-contractors for recruiting, what accrual should be included?

All accrual should be entered and assigned to the appropriate enrollment sites within OnCore.

OnCore Requirements for VA Protocols

I am enrolling subjects only at the VA. Does my study need to go in OnCore?

Yes, if ALL the following criteria are met!

  1. OnCore Registration requirements are met.
      • Clinical study (interventional, observational & expanded access)
      • Prospective research
      • Informed consent
  2. The PI/VA investigator has an IU paid appointment and is utilizing the IU paid appointment on the study.
I am enrolling subjects in parallel at the VA and IU or an IU-affiliated institution. Does my study need to go in OnCore?

Yes, if OnCore Registration requirements are met.

    • Clinical study (interventional, observational & expanded access
    • Prospective research
    • Informed consent
My study is considered to be collaborative research between the VA and IU. Am I allowed to enter subjects in OnCore?

Yes, if ALL the following criteria are met, you will individually register subjects in OnCore.

  1. OnCore Registration requirements are met.
      • Clinical study (Interventional, Observational & Expanded Access
      • Prospective research
      • Informed Consent
  2. VA studies that share VA data outside the VA are required to obtain the following:
      • VA Research Data Ownership Agreement (RDOA, or other agreement)
      • VA R&DC submission & approval
      • VA Information Security Officer (ISO checklist) and VA Privacy Officer (PO, form 10-250) approvals
      • VA specific consent, VA specific HIPAA Authorization (Form 10-0493) 
      • VA Collaborative form

VA requirements are signed and approved by the VA RDC. To access the VA documents navigate to this IU Research webpage and scroll down to the VA Research Documents tab under Additional Resources at the bottom of the page where you will find the following 3 documents:

      • VA Consent
      • VA HIPPA
      • VA Investigational Drug Information Record

For a full set of VA documents and to discuss VA requirements for opening research at the VA (by a VA paid investigator) contact the VA Research Administration office (contact information is below).

NOTE: All VA subject SSN/MRN’s must be de-identified (eg: Short Title-Patient Sequence Number) Example: IMPACT-1001


What is considered collaborative research?

  • Collaborations between investigators from more than one institution interactingwith each other on the research project.
  • Multi-site research is not considered to be collaborative unless the RLR VA investigator shares VA research data or resources with a Non-VA entity, such as use of IU Red Cap, and there is an agreement with the IU collaborative investigator. In this case, a signed written agreement (ie, RDOA) is required to share “copies” of VA “original” data outside the VA with another investigator who is a collaborator. It is possible that the VA and the IU investigator are the same person.
  • Abbreviations
  • RDOA-RLR VA: Research Data Ownership Agreement
My study is considered VA-Only research. Am I allowed to enter subjects individually in OnCore?

No. Subjects can only be entered in OnCore using “Summary Accrual.”

NOTE: VA-Only Research: Does not have collaborations (interactions) between a VA investigator and any investigator(s) from another institution. VA Sensitive Information (VASI) on non-VA information is not allowed in VA-Only Research without Federal security controls/requirements. 

If I have questions about OnCore eligibility for VA protocols, who do I contact?

Please contact the RLR VA Research Administration:

Marta.Sears@va.gov        317.988.4202
Angela.Harris11@va.gov    317.988.4201

OnCore Financials

When can I begin entering information?
  • Entry can begin as soon as you receive the “OnCore Initial Calendar Ready for Review” notice. 

  • It is sent to the following staff as listed in OnCore:  Study Site Contact, Budget Contact and Central Administrator 
  • Modifications may need to be made multiple times before the study is Open to Accrual (i.e. after coverage analysis is complete, after budget has been finalized, ect…). 
Where do I build my Financials?

You will build your Financials in the Production environment.

Where do I review and test my Financials?

You can review and test your Financials in the Development environment:  https://iuctsi-oncore-dev.forteresearchapps.com/.  Your user name and password should be the same as in Production. 

How do I review and test my Financials?

Build in Production, Test in Development!

  • Data in the Development environment is refreshed every Tuesday and Friday at 9 pm EST.  This means that anything you enter in Production will be transferred to Development at that time.  It also means anything you entered or updated in Development will be overwritten at that time.

  • You may need assistance from your Calendar Analyst to Release the Calendar and Open the study for testing and review purposes.  Your Calendar Analyst is listed on the Staff tab of the PC Console. 
Who does the testing and review?

We recommend the Budget Contact/Business Manager test and review in conjunction with the study team, particularly the research coordinator(s). 

Why is it important to test and review your Financials?
  • Changes are difficult to make after patient visits have been verified in the system.  In some cases, you may not be able to undo your mistakes. 

  • Reversioning the Budget and Calendar is not fun!  Having multiple versions of each can cause a lot of confusion as individual patient data and visits are verified and later reviewed for accuracy. 
  • OnCore Support Documents

Minimum Standardized Requirements for Indiana University & IU Health

  • Policies & Procedures

Access to Indiana University’s clinical research management system, OnCore, is based on your need to access and your assent to use that access appropriately. Please see Acceptable Use Agreement below.

Acceptable Use Agreement
  • Online Resources

Advarra University

More information on all aspects of Advarra Technology Solutions (OnCore, Participant Payment, eReg) can be found on the Learning Portal or within Advarra University, including additional training guides, training videos and webinars. Access the Learning Portal from within the application by going to the Help menu in the toolbar located under your name or by clicking on the “?” located in the upper right-hand corner of each page. Visit Advarra University

Onsemble.net

Research staff can also become part of the Onsemble Community, an exclusive group of research professionals who use Advarra solutions. Users from different organizations have the ability to connect with each other, share experiences, tips and tricks, workflows, SOPs, and trouble-shooting suggestions and solutions. To access the site, request a username and password from the site itself. Visit Onsemble.net

CONTENT SHORTCUTS

To register for OnCore:

Request OnCore Access & Training

To access OnCore after registering:

Log in to OnCore
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