Clinical Trial Agreements

Information for Sponsors and CROs

Expand the applicable category below for key information about CTAs relevant to sponsors and CROs (including links to download relevant documents). 

Clinical Trial Agreement Process

The decision to be a participating site in a clinical trial is made at the unit level.  Sponsors/CROs should work directly with the UCMC physician or study team with the applicable area of expertise appropriate for the trial to provide all the required study information and documents.  Once this is collected, and the study has completed the scientific review process, the assigned study manager will submit the study through UChicago’s internal process to initiate budget and contract review.  Sponsors/CROs will be informed of the assigned regulatory, budget, and contract contacts for each study.
Sponsors and CROs can help expedite the contract review process by being familiar with the details of UChicago's CTA Negotiation Fee and ACTA program.
Please note:  contracts sent by email directly from a sponsor/CRO outside of this process will not be accepted or reviewed.

CTA Negotiation Fee

CTA NEGOTIATION FEE: MEMO TO SPONSORS & CROs

As part of UChicago’s dedication to opening clinical trials faster, the Biological Sciences Division (BSD) and University Research Administration (URA) will be piloting the use of a new Clinical Trial Agreement Negotiation Fee (CTA Negotiation Fee) for all industry sponsored clinical trials.

The $15,000 CTA Negotiation Fee will be assessed to all industry sponsored clinical trials where a Clinical Trial Agreement (CTA) must be negotiated between The University of Chicago and the industry clinical trial sponsor or a Contract Research Organization (CRO) on behalf of an industry clinical trial sponsor.

The CTA Negotiation Fee will only be waived if the industry clinical trial sponsor utilizes either an existing Master Clinical Trial Agreement (MCTA) or the Accelerated Clinical Trial Agreement (ACTA).

MCTA Waiver Option:

  1. Sponsors/CROs can check the URA Website for a list of existing MCTAs. Please note: Many of these MCTAs may be used by affiliates and subsidiaries of the company listed.
  2. The sponsor/CRO must adhere to the contract terms and work order template agreed to in the MCTA. Revisions to the work order that modify the original terms of the MCTA are considered negotiation and will cause the CTA Negotiation Fee to be incurred.
  3. URA may, in its sole discretion, consider waiving the CTA Negotiation Fee if the work order contains only minor modifications that are required due to the nature of the study (i.e. changes for a non-interventional study).

ACTA Waiver Option:

  1. The ACTA must be accepted in strict accordance with URA Guidelines.
  2. Only the ACTA templates available on the URA website will be accepted.
  3. The sponsor/CRO must complete the template following the instructions in the cover letter exactly – any deviations will cause the CTA Negotiation Fee to be incurred

Using Sponsor/CRO CTA Templates:

If the sponsor/CRO requires its own CTA template be used the CTA Negotiation Fee will be assessed in full.

It is highly recommended that Sponsors/CROs review these options in advance and determine which route they wish to take.  If they are not already familiar with the ACTA, it is recommended that the appropriate version be downloaded from the URA website and reviewed by sponsor’s legal team.

Once the study has been submitted by the study team through the University’s internal process, a Budget & Contract Manager (BCM) will be assigned for budget negotiation and a Clinical Trials Officer (CTO) will be assigned for contract language negotiation.  The assigned CTO will reach out to confirm which option will be used.  If the sponsor/CTO does not select one of the waiver options at this point, the CTA Negotiation Fee will be assessed in full.  Once the sponsor/CRO template agreement provided is reviewed by the CTO, the opportunity to claim a waiver has passed.  The sponsor/CRO may opt at any point during the negotiation process to switch to the ACTA.  However, sponsors/CROs making this change once negotiations have begun will not be eligible for the waiver.

Master Clinical Trial Agreements

UChicago currently has Master Clinical Trial Agreements in place with a number of industry sponsors.  Many of these agreements can be utilized by affiliates of the entity listed:

AbbVie EMD Serono Merck Sharp & Dohme Corp
Alexion Pharma Genentech (Roche) Novartis Pharma Corp
Alpha Oncology Genocea Biosciences Novo Nordisk Pharm
Amgen Gilead Sciences Pfizer
Astellas GlaxoSmithKline Regeneron Pharma
AstraZeneca Immatics US Sanofi US
Biogen Idec Janssen SeaGen
Blackrock Microsystems, LLC Lexicon Pharma Takeda Pharma
Bristol-Myers Squibb Medtronic UCB Pharma
DuPont Pharma Company    

 

 

Using the ACTA

We offer sponsors and CROs the opportunity to use the Accelerated Clinical Trial Agreement (ACTA) template as part of the University’s commitment to expedite the contracting process and facilitate clinical trials opening faster. Projects that utilize the unmodified ACTA will be fast-tracked for contract negotiation.  We can do this because the unmodified ACTA requires no negotiation.

Only use of the unmodified ACTA qualifies a study for expedited contract review.

Use of the unmodified ACTA qualifies a study for waiver of the CTA Negotiation Fee.

What Is the ACTA?

The ACTA is a neutral, streamlined clinical trial agreement template that is broadly accepted by both industry sponsors and institutions. It was developed by a working group of industry sponsors, CROs, and research institutions to achieve mutually agreeable contract language that favors neither the sponsor nor the institution.  The ACTA is not a UChicago-originated template.  More information about the ACTA is available at these websites: UIDP and Accelerated Research Agreements.

Is It Really Faster?

When the ACTA is used without modification, the contract can be finalized in as little as 2 business days*.  The agreement often is executed within 5-10 business days of sponsor’s return of the completed template, provided the budget has been finalized*.

How to Use the ACTA:

There are three ACTA templates available:

  1. Standard ACTA: contracting parties are sponsor and institution;
  2. CRO-ACTA: contracting parties to the CTA are CRO and institution, separate letter of indemnification between sponsor and institution included as exhibit;
  3. International ACTA:  parties are sponsor and institution; used when the sponsor is a foreign entity.

Each template has been pre-filled with certain UChicago information.  For your convenience, the areas that require sponsor or study specific information have been highlighted in yellow.  Complete those fields ONLY – make no other changes –  and return the template to the UChicago contact who provided it to you.  If you receive this template early in UChicago’s internal process, your contact likely is the assigned Research Coordinator. 

Once the internal submission has been completed, the assigned Clinical Trial Officer will contact you to finalize the agreement.

PLEASE NOTEANY REVISIONS WHATSOEVER to the ACTA template will disqualify the study for expedited contract review, and the agreement will be reviewed according to its position in the queue.

*PLEASE NOTE:  The contract, budget, and regulatory processes are three separate processes that are undertaken in parallel.  Separate UChicago contacts will be assigned to this study for each of these processes.  Contract execution requires that both contract language and study budget are finalized but does not necessarily require that the IRB process is complete.  However, the study cannot open until the contract is fully executed and the study has IRB approval. 

 

Information for UChicago Faculty and Staff

Click here for additional information and guidance on internal processes, policies and resources. Please note: You will be required to login using your CNet ID for access. 

 

December 7, 2023