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Research and Sponsored Programs

Clinical Trial Agreements

Page Updated: July 18, 2025

A clinical trial agreement (CTA) is the written contract that outlines the roles and responsibilities of the parties when conducting a clinical trial. The CTA often comes into play when a sponsor pays UW-Madison to test the safety or efficacy of a potential medical treatment. This could include drug testing, device testing, diagnostic testing or procedure testing on humans. Many of the terms and conditions in clinical trial agreements are driven by FDA regulatory requirements and Good Clinical Practice requirements. These terms and conditions are intended to safeguard research participant health. Because these clinical trials are usually the precursor to the commercial launch of a new treatment for a company, they often come with publication, confidentiality and intellectual property restrictions to protect the sponsor’s market position.

Because clinical trials involve human participants, there are strict regulations as to how clinical trials can be conducted. For example, clinical trials will often have human subject protections to ensure that proper training and safeguards are in place for the participants. Additionally, physicians conducting interventional clinical trials are required to obtain informed consent from the participants prior to providing the intervention to be sure that the participants are made aware of the risks associated with the intervention. Beyond this, clinical trial agreements will contain language that provides for adverse event reporting and medical treatment if something goes wrong with the clinical trial. All of this is to make sure that the participants in the trial are protected as much as possible.

Important CTA Considerations

Routing Agreements for Review

Unlike typical sponsored agreements, Clinical Trial Agreements are often negotiated before all the project details (protocol, budget, etc.) are worked out. This means that Clinical Trial Agreements will (often) be routed to RSP on a RAMP Agreement record before there is a RAMP Funding Proposal (FP) record. This is OK provided that, prior to RSP executing the CTA, RSP will require that there is a completed RAMP FP record with PI Certification and Dean’s Office sign off (at minimum, University departments or the Dean's Office may have their own additional requirements).

Industry-Sponsored Clinical Trials: The RAMP Funding Proposal record must include a total estimated budget amount. This budget should reflect the anticipated total costs for the clinical trial, including startup costs, total participant enrollment, and other associated expenses, assuming maximum participant enrollment. See the RAMP Job Aid for CTA Budget Entry for additional instructions.

Federal (direct and flow-through) Clinical Trials: A full budget must be entered in the RAMP Funding Proposal record.

F&A Rate
  • The F&A rate for industry-sponsored clinical trials is 32% effective 7/1/2025.
  • Federal CTAs, including when we are a subrecipient, should be using the appropriate federal F&A rate, currently 55.5% effective 7/1/2023.
  • Non-standard rates: need email documentation and, if available, previous records in WISPER and/or RAMP to obtain a waiver (may or may not be approved).
CTA Negotiation Process and Documentation
What documents are needed to negotiate and execute a CTA?
  • The CTA itself (if the sponsor is party to the CTA).
  • Letter of Indemnification (LOI) with the sponsor when a Contract Research Organization (CRO) is party to the CTA.
    • Please attach the LOI to the RAMP record (Supporting Documents) to facilitate processing and review.
What approvals are needed for RSP to execute the CTA?

The RSP CTA Team will send a RAMP Ancillary Review (AR) request to campus contact to confirm that FP has PI certification and Dean's Office approval. Additionally, the team will ask for confirmation that the budget is final and RSP can proceed with execution of the Agreement.

CTA Amendments

All amendments to CTAs are processed through the RAMP Agreement Process:

  • If there is an existing RAMP Agreement record for the CTA, please use the “Create Amendment” option in the existing RAMP Agreement Record.
  • If the original award came from WISPER AND a recent amendment was made in RAMP, please use the “Create Amendment” option in the existing RAMP Agreement Record for that most recent amendment.
  • If the original award came from WISPER and THERE IS NOT a recent amendment that was done in RAMP, please create a new RAMP Agreement Record using the amendment as the agreement to upload and include the original agreement as “Supporting Documentation.”
Frequently Negotiated Agreement Terms

Please note that each document is assigned to an RSP CTA Team member for full review. When complete, the following key items will be negotiated with the Sponsor and/or CRO:

Publication

The CTA must allow UW-Madison to freely publish the results of the study, excluding any approval rights on publication granted to the Sponsor. UW-Madison can agree to terms providing for Sponsor review of the forthcoming publication to identify proprietary or confidential information.

Confidentiality
  • Marking requirement of all confidential information disclosed to the UW-Madison team and obligation to reduce disclosures in other forms to writing within 30 days.
  • All CTAs should have a time limit for trailing confidentiality obligations (obligation to keep information confidential by the UW-Madison team).
Indemnification

Sponsor must agree to indemnify and hold harmless UW-Madison, the Principal Investigator, agents and employees from all liabilities, claims, actions for personal injury or death arising from the administration of the study drug or because of study procedures in accordance with the study protocol.

Subject Injury Language
  • For externally-initiated trials with for-profit entities, UW-Madison expects the external entity will be responsible for reimbursing costs of medical treatment for study subjects injured by study interventions.
  • For externally-initiated trials with non-profit and government entities, there is typically not an expectation that the external entity pay subjects’ injury costs. However, these agreements must clarify that such costs are not covered.
  • For investigator-initiated trials: an external entity may provide study funding and/or study drug/device, however, the study protocol is developed by the UW-Madison PI and study team. Typically, there is no subject injury provision in investigator-initiated study agreements.

Agreement language covering subject injury should be consistent with the UW IRB approved consent language. When using UW-Madison's consent template, that language can be found in HRP-502. When using a sponsor's consent template, UW-Madison specific consent language can be found in HRP502(c). For questions on consent language, please contact the UW-Madison local IRB.

Safety reporting (AAHRPP)

RSP CTA Negotiators are reviewing CTAs for safety surveillance language based on guidance received from the UW-Madison Office of Research Compliance. Preferred language includes prompt notice of material safety issues.

Intellectual Property
  • For externally-initiated trials: Considering that the protocol is developed by an external entity, the external entity often retains rights to all inventions during the study lifecycle performed at UW-Madison.
  • For investigator-initiated trials: UW-Madison retains ownership rights to inventions that result from the protocol developed by the UW-Madison PI (as sponsor-investigator of the study).