Getting Started

Below is an overview of the clinical trial process at Indiana University and IU Health. The numbers in the process map correspond to the steps that need to be completed by the study team. Click on the plus signs for additional information. The clinical process steps are further explained below the process map. If you have additional questions, please contact our OCR team at ocr@iu.edu.

Clinical Trial Process Map

To protect confidential information exchanged between Indiana University or Indiana University Health and third parties, the execution of a Confidential Disclosure Agreement (CDA) is required.

To request the negotiation and signature of a Confidential Disclosure Agreement (CDA) for a clinical trial, please click the Request CDA button and complete the form.

You will be notified when your request is complete.

The Office of Clinical Research has a study initiation form to collect the needed information and documents for entering a new protocol into OnCore (IU’s centralized clinical research management system). This form, which also initiates the Coverage Analysis Review process, should be filled out and submitted as soon as a final protocol is available. The study initiation can happen simultaneously with IRB submission and contract negotiation, with each process informing the others.

Centralized Coverage Analysis is mandated across the institute to ensure compliance with federal regulations and goes hand-in-hand with OnCore’s protocol entry; therefore, entering accurate information is critical to ensuring that a study complies with university policies and federal requirements. IU is cultivating OnCore as a “source of truth” for information about clinical research occurring at IU and IU Health. The Coverage Analysis Team (CAT) uses information collected in this form to

    • develop the OnCore protocol entry,
    • communicate with the study team throughout the Coverage Analysis Review, and
    • identify ancillary services involved in the study. More information about Coverage Analysis can be found here.

  • The Study Record is created. The submission is routed to the Calendar Analysts who use the information in the first section of the form to create a study record in OnCore. This record, also referred to as the “OnCore Shell,” may be used for effort tracking, pipeline review, and other initial study management tasks within OnCore.
  • The Study Calendar is created. If coverage analysis is necessary, the Calendar Analysts begin building a study calendar in OnCore.
  • The Billing Grid is used to document coverage analysis. Coverage analysis is completed within the Coverage Analysis Console, which may be found in the “Financial” drop down from the menu in OnCore. Inside the Coverage Analysis Console, the Billing Grid is used to provide the documentation of the Coverage Analysis. The Billing Grid includes a version of the study calendar that designates each procedure as being billed to the study “R,” or billed to the subject “S.” Additionally, the Billing Grid includes a comments section, this is where you will find justifications for the procedures designated to be billed to the patient/patient insurance. These justifications come from Medicare National and/or Local Coverage Determinations, National Guidelines (i.e. NCCN, American Heart Association), and Peer Reviewed Journals.
  • The Study Documents are aligned. Additionally, and of equal importance to the billing grid, is the piece of Coverage Analysis referred to as a Document Alignment. This procedure consists of reviewing the Protocol, Informed Consent, and funding documents (i.e. Sponsor or department Budget, Clinical Trial Agreement, or Grant Approval Document) to ensure consistency of Subject Injury Language and Subject Stipend/Reimbursement. The patient injury language needs to align with Medicare “Payer of Last Resort” rules. Specifically, these documents need to state that either the patient or patient’s insurance is responsible for the cost of the procedures if a patient is injured while on the study, or the Study or Study Sponsor is covering all of those costs. An example of unacceptable language is, “Sponsor will pay for any costs not covered by patient insurance, if injured while on this study.” This language indicates that the sponsor will pay copays and deductibles and this cannot be allowed.
  • The study information is reviewed. After receiving notice of completion of the coverage analysis, PIs, coordinators, and other members of the research unit are responsible for reviewing the Billing Grid and the communication from the Coverage Analysis team. If there are questions, comments or concerns on the part of the Research Unit, it should be discussed with the Coverage Analysis Team for clarification.

**Please note: The study initiation form begins the process of entering a new study into OnCore and also initiates the coverage analysis review; however, this form does not initiate an IRB submission.

All Clinical Trial Agreements for researchers at Indiana University and IU Health should be routed to the Office of Clinical Research. The Clinical Trial Agreement (CTA) is a legally binding contract that defines the scope of work required by the protocol and allocates the risks and responsibilites among the sponsor, site, and researcher. The contracts team at the Office Clincal Research works with investigators and sponsors to develop CTAs acceptable to the investigator and to Indiana University or IU Health.

All Clinical Trial Agreements for researchers at Indiana University and IU Health should be routed to the Office of Clinical Research. The Clinical Trial Agreement (CTA) is a legally binding contract that defines the scope of work required by the protocol and allocates the risks and responsibilites among the sponsor, site, and researcher. The contracts team at the Office Clincal Research works with investigators and sponsors to develop CTAs acceptable to the investigator and to Indiana University or IU Health.

Prior to conducting human subjects research, protocol review and approval by an Institutional Review Board (IRB) is required. The IU IRBs are the IRB of record for all IU campuses as well as our medical center affiliates, including IU Health, Eskenazi, and Roudebush VA Hospital. Additionally, IU allows the use of external IRBs, including independent IRBs and other academic medical center IRBs, under certain circumstances. Permission to use an external IRB must be requested from the IU Human Subjects Office via Reliance Request in KC IRB. Additional information can be found here. For help with your IRB submission, please contact the Human Subjects Office.

    IU Human Subjects Office
    Phone: 317-274-8289
    Email: irb@iu.edu

Step 5: Request access to OnCore

 
Indiana University Employees

IU Health and Other Affiliates

Step 6: Request access to Cerner

 

Cerner Access
IU Health Research Related Systems Access

Contracts

The OCR Contracts team handles all contracts for IU and IU Health and its investigators for all industry-sponsored clinical trials (no government funding) for studies involving human research subjects (no bench research). The OCR also provides the necessary information and tools needed to successfully collaborate with Indiana University, its strategic partner IU Health, and its other research collaborators. For more information, go to our Contracts page.
contact the OCR directly.

Indiana University
Attn: Office of Clinical Research
410 W. 10th Street, Suite 1020
Indianapolis, IN 46202
Email: ocr@iu.edu
Phone: (317)278-2546 Centralized Study Initiation

Training & Support Quick Links

Training and support for OnCore
PowerChart, PowerTrials, and Recruitment
Kuali Coeus
KC IRB
CITI Training
CTSI Education & Training for Reseach Coordinators
IU Office of Research Compliance Education Sessions
Guides for OnCore Protocol and Subject Entry

This link will direct you to IU Box where the following documents are stored:

    • This link will direct you to IU Box where the following documents are stored:
    • Protocol, Subject and Calendar Visit Tracking
    • Minimum Standard Requirements (Footprints)
    • Registration Requirements
    • Frequently Asked Questions
    • Study Workflows
    • PowerTrials-RPE Documents

Please use your IUSOM credentials to sign in at IU Box.