Information for Sponsors and CROs Regarding 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.

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.