OnCore

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.

Confidential Disclosure Agreement

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

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

Yes, if OnCore Registration requirements are met.

• Clinical study (interventional, observational & expanded access)
• Prospective research
• Informed consent

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

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.

Please contact the RLR VA Research Administration:

Marta.Sears@va.gov

317.988.4202

Angela.Harris11@va.gov

317.988.4201

• 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…).

You will build your Financials in the Production environment.

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.

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.

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

• 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.