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Indiana University School of Medicine
Indiana University Office of Clinical Research
Roadmap

Submit Contract or Sub-Award for Review and Negotiation

Routing a clinical research contract at Indiana University (IU) follows a structured process to ensure compliance with university policies, protect the institution and researchers, and meet sponsor requirements. A Contract Officer within the Office of Clinical Research (OCR) or the Office for Research Administration (ORA) will handle contract negotiations based on the sponsor type. Principal investigators cannot sign agreements before review and negotiation by the appropriate contracting office. Any agreement lacking proper institutional signatures is invalid. The parties will be the sponsor, Trustees of Indiana University, and IU Health, Inc. The PI signs only as read and acknowledged.

These Guidelines to Determine the Appropriate Contracting Office will help research teams determine which offices should receive the contract for review. You can track the status of your contract and grant routings in the Grants Management Toolkit (GMT), a reporting tool that allows principal investigators, fiscal officers and associates to view the status of externally sponsored proposals and awards as well as financial details of funded awards.

The OCR and ORA utilize Kuali Coeus (KC) Grants for contract routing and review. To access KC Grants at Indiana University, you need to log in to the One.IU portal and search for the “Grants and Contract” tile. After you click on this tile, navigate to the “KC Grants” section in the left-hand menu to create a Proposal Development Document. CAS Authentication and special permissions are required. If you need assistance, contact your unit’s grant administrator or ORA at ora@iu.edu.

Industry-sponsored or supported contracts for Indiana University investigators must be reviewed and negotiated by the OCR Contracts team. Documents requiring routing through Kuali Coeus (KC) Grants include:

  • Clinical Trial Agreements (CTA)
  • Work Orders (WO), Task Orders (TO), or Statements of Work (SOW)
  • Sub-Contracts to IU
  • Amendments that increase the overall budget or change the Principal Investigator (PI)

For CTA, WO, TO, and SOW KC Grants routing, submissions must include the draft/template agreement, draft budget, protocol, and informed consent form (ICF) as applicable. Amendment routing must include the draft/template agreement and final budget.

Certain documents may not require routing through KC Grants, such as:

  • Subcontracts to outside institutions
  • Amendments to subcontracts with outside institutions
  • Amendments that do not increase the overall budget or address changes

Non-routed agreements should be emailed to ocr@iu.edu and must include the draft/template agreement, sponsor contact name, and email address. Amendments should also include a summary of changes. Subcontracts to outside institutions must also include a subcontract request form, which is available in the resources below.

Additional information about the OCR Contracts team, including document templates and frequently asked questions, can be found on the OCR Contracts website.

Industry-sponsored or supported contracts for Indiana University Health Investigators must also be reviewed and negotiated by the OCR Contracts team, however they will not be routed through KC Grants. Affiliate study teams should submit the IU Health contract through the OCR Contract Intake Form which can be located by navigating to IU Health Research Contracts or by going directly to the form here.

The Office of Research Administration reviews and negotiates non-industry research agreements. To learn more about the types of research agreements that ORA will review, visit the Research Agreements website. For details on routing non-Industry research agreements to the Office of Research Administration, visit the Proposal Routing and Submission website for policies and resources.

The ORA is also responsible for reviewing, negotiating, and signing several types of unfunded agreements related to non-Industry research and service as well. Some examples may include:

  • Non-Disclosure or Confidentiality Agreement
  • Material Transfer Agreement
  • Data Use, Data Sharing, and/or Data Transfer Agreement
  • Unfunded Research Agreement
  • Master Agreement
  • Facility Use Agreement

If you receive any unfunded agreements or become aware that one may be needed, please complete the ORA Contract Request Form by navigating to the tile in One.IU.edu or by going directly to the form here (CAS Authentication required).

In some cases, your study may require a Data Sharing Agreement outside of the IU Health/IU Master Data Sharing Agreement. Resources and information about the IU Health Data Sharing Process are located on the OCR website, including an IU Health and IU Data Sharing Workflow and Frequently Asked Questions document. For questions, contact IU Office for Research Administration: ora@iu.edu or IU Health Clinical Research Support: clinicalresearchsupport@iuhealth.org.

Contacts and Resources

OCR

ORA

Submitting your contract or sub-award for review and negotiation is only one component of study activation. Additional requirements should be reviewed using the Clinical Research Roadmap.