Clinical Trial Agreements

The majority of the clinical trials conducted at the University are studies that are sponsored by for-profit entities (i.e. pharmaceutical companies, medical device manufacturers, etc.).  The industry partner owns and leads the investigational protocol for these trials. Industry-sponsored trials can be interventional, non-interventional, observational, or registry studies.

• Initial submission of the CTA should be in ARTEMIS; please work with the Budget & Contract Manager that supports your unit (CTFG, OCR, Surgery, etc.) to initiate CTA submission.
• For studies sponsored by a for-profit entity testing interventions, or whose ultimate intent is to provide data to the FDA, the clinical study indirect cost rate of 30% applies.¹
• For observational studies supported by commercial sponsors, the rate for for-profit sponsors funding basic research, instruction, or other sponsored activities applies (64% of total direct costs).²

1. ^{For anomalous cases concerning whether the clinical study cost rate applies, the Biological Sciences Dean's Office will be consulted.}
2.  ^{See the Quick Reference Fact Sheet for detailed information and the most up-to-date IDC rates.}

The University also participates in clinical trials that are sponsored by other institutions, non-profit organizations, or consortia.  As with industry-sponsored trials, these studies can be interventional, non-interventional, observational, or registry in nature.  Often, the agreement provided by the sponsoring entity will be called something other than a clinical trial agreement, such as a Subaward, a Subsite or Participating Site Agreement, a Research Collaboration Agreement, etc.  Occasionally, such agreements may also be presented as a Data Transfer/Use Agreement, or even a Material Transfer Agreement (i.e., when biosamples are being sent).  It is important to recognize that when the nature of the activities the University will be performing fulfill the NIH definition of a clinical trial, the agreement must be submitted and processed as a CTA, regardless of what it is called by the sponsor.

The system that should be used for the initial submission of the CTA depends on the type of payment the University will receive for participation in the study:

• If the budget includes any per-patient reimbursement, the CTA should be submitted in ARTEMIS; please work with the Budget & Contract Manager that supports your unit (CTFG, OCR, Surgery, etc.) to initiate CTA submission.

• If payments are made strictly on the basis of milestones achieved, please work with the Grants and Contracts office that supports your unit (GCO, OCR, Surgery, etc.) to submit the study in AURA Grants for the purpose of budget review and tracking.
  • If the study is entirely federally funded, and the agreement is presented on a standard FDP template, the assigned URA Post-Award Research Administrator can process the agreement, and only the AURA Grants record is required.
  • If the underlying funding source for the study includes an industry partner or a foundation, an associated AURA Agreements record must be created and submitted under the CTA agreement type in order to process the agreement.

• If there is no funding associated with the study, the agreement should be submitted directly into AURA Agreements under the CTA agreement type.

• For studies conducted under federal sponsorship, the negotiated federal indirect cost rate applies.
• For studies sponsored by a non-profit entity testing interventions, or whose ultimate intent is to provide data to the FDA, the clinical study indirect cost rate of 20% applies. ^{1, 2}

1. ^{For anomalous cases concerning whether the clinical study cost rate applies, the Biological Sciences Dean's Office will be consulted.}
2. ^{In the event the non-profit entity has a published indirect cost rate below 20%, the University will accept the published rate. Any other request to deviate from the rates described here requires an IDC Waiver.}

Investigator-Initiated Clinical Trials are trials for which the PI has conceived of the hypothesis to be studied and has written the protocol (scope of work).

As with the trials sponsored by outside parties, the nature of these trials can be interventional, non-interventional, observational, or registry studies.  The University will act as the sponsor, as defined by the FDA, of the study. Funding and other support for the study can come from a number of sources:

• For internally funded clinical trials, that is, studies that are entirely supported by departmental funds, URA does not require an agreement to be put into place to conduct the study within the University.  However, an ARTEMIS record may be required – contact OCR or the Budget & Contract Manager that supports your unit (CTFG, Surgery, etc.) for guidance.  In addition, if other institutions will be recruited to participate in the trial, a request for an Outgoing Subaward (SUB) agreement for each institution must be submitted in AURA Agreements. 
• If the PI wishes to submit a proposal to a federal funding source (ex. NIH R01 grant), a Funding Proposal (FP) should be submitted in AURA Grants and making sure to indicate that the Main Project Purpose is Clinical Trial. At the proposal stage, the clinical trial does not need to be reviewed by OCR. After submission of the clinical trial proposal, URA will provide OCR with a copy of the clinical trial. If the clinical trial is awarded, OCR must review and provide concurrence.
• If the PI wishes to respond to a formal request for proposals issued by a non-federal funding source (industry sponsor, foundation, etc.), they should begin by engaging the office that provides budget or grant support for their unit (CTFG, GCO, OCR, Surgery, etc.).  In most cases, an FP will be submitted in AURA Grants, but working with correct budget manager is critical to ensuring that the budget submitted in the proposal is sufficient to cover the costs of the study as envisioned by the PI.
• In some cases, the PI may wish to reach out to an industry or foundation partner to determine whether there is interest in providing support for a study in the absence of any formal invitation for proposals.  In such cases the first step in the process should be to submit a request in AURA Agreements for a Non-Disclosure Agreement (NDA).  This often overlooked step is critical to ensure that your novel study design is protected as you work toward finding funding for the trial.

As soon as the PI has received confirmation of interest from the funding partner – whether in the form of an award letter, or simply an email confirming interest in supporting the study – an AURA Agreements record should be initiated:

• If there is an AURA Grants record in place (either an FP or an AWD), work with the assigned URA Research Administrator to coordinate the submission of a new AURA Agreements record under the CTA agreement type utilizing the “Create Agreement” function in AURA Grants.
• If there is not an AURA Grants record in place, the PI, the research coordinator, or someone from the office that provides budget or grant support for their unit (CTFG, GCO, OCR, Surgery, etc.) should create and submit of a new record directly in AURA Agreements under the CTA agreement type.
• The CTA submission should include any documents provided by the funding partner for review or signature, but if a template agreement has not been provided, check the “Institution to generate first draft” box and the University’s IIT template agreement will be customized for this trial.  This IIT Supplemental Information Form must be included as a supporting document in the submission.  Other supporting documents that should be uploaded (or provided once they become available) include:
  • Copy of proposal or scope of work
  • Award letter or confirmation of interest
  • Preliminary budget information
  • Protocol

• Once the regulatory aspects of the study have progressed to the point that the IRB and ARTEMIS records can be created, the appropriate links and cross-references will be made to the AURA Agreements record.

These types of agreements can go by a number of names (another common one is Memorandum of Understanding), and are arrangements in which the University enters into an umbrella agreement to conduct a number of different clinical trials.

Often, these agreements are funded by a large federal grant, but may also provide different sources of funding for each clinical trial. These agreements may be presented in the absence of the identification of a particular study the University wishes to participate in, or in conjunction with such a study (often taking the form of a work order or individual study agreement). 

Either way, these agreements should be routed to URA in AURA Agreements as a Master Agreement (MAS). Typically, a separate work order or similar type of agreement will be provided for each study conducted under the master agreement. Each such work order would be treated as a separate CTA (as described above) and linked to the MAS record. Nonetheless, each of these agreements is unique, and departments are encouraged to contact URA with any questions regarding processing and administering the agreement and the trials conducted thereunder.