Early Termination


Early Termination of Industry Sponsored Clinical Trials

Under normal circumstances, it is institutional practice to set up industry-sponsored studies with a budget period that runs for a year beyond the project period (i.e., the time the work is being done) to allow for final costs to be submitted to the sponsor, final payments to be received by the Augusta University Research Institute (AURI), and all expenses to clear AURI/ Augusta University (Augusta University) accounts. Occasionally, studies may terminate early - for example, when a Principal Investigator (PI) leaves Augusta University and a new PI is not named, when the FDA cancels the study, when the IRB terminates its approval, or when the sponsor cancels a study due to enrollment targets having been met or an investigator's inability to meet study benchmarks. When a study terminates early, additional activities related to the closeout that extend beyond the project period may result in some continuing charges, such as study coordinator effort to wrap up regulatory requirements or to provide orderly subject data completion, or costs related to long-term storage of documents. In order to be charged to the study, these costs should be required, should be reasonable, and should not be incurred beyond the first 60 days after the study terminates.

In order to provide for an orderly and timely closeout, we are implementing the following procedure for industry-sponsored studies which are terminated early:

The PI will inform the Human Assurance Committee that IRB approval is to be terminated by completing one of the following:

For studies reviewed and approved by thesAugusta UniversitysIRB (HAC): HAC Form 107 (“Clinical Study Status Report”) or Form 111 (“Final Report for HAC Termination or Study Completion”).

For studies reviewed and approved by Chesapeake Research Review, Inc. (CRRI): Continuing Review/Progress Report/Termination Report Forms.

The PI or the PI's designee also will send an email to the Division of Sponsored Program Administration with an effective termination date and information regarding the reason for early termination.

The Division of Sponsored Program Administration will send an email to the sponsor to provide:

Notification that the PI has indicated that the study is to be terminated.

Notification of the date(s) of the IRB and the contract terminations.

Notification that study closeout has been initiated, and that a final invoice will be submitted to the sponsor within 90 days of the contract termination. Unless there is specific language in the contract that differs, the email will state that the sponsor's final payment will include all study related costs incurred through termination as well as all non-cancelable commitments.

A copy of the email will be sent to the PI, the study coordinator, the appropriate sponsored accountant, and the Office of Clinical Investigative Services. The email will be followed by formal letter notification executed on behalf of AURI.

The study coordinator will submit the final invoice to the sponsor and copy the appropriate sponsored accountant.

 

The sponsored study account will remain open for an additional 90 days from the final invoice date.

During this period, all outstanding sponsor payments should be receipted, outstanding study invoices should be received for payment, and financial obligations to vendors met.

It is important to note that this procedure applies only to industry-sponsored studies that terminate early. Any studies that are supported in whole or in part by federal direct funding or federal flow-though funding must be closed in accordance with federal regulations. Costs incurred after IRB/contract termination will be closely monitored for appropriateness , and questionable costs will require justification.PI terminates the IRB approval effective April 1, 2005. DSPA will email sponsor indicating that study contract should terminate effective April 1, 2005. Final invoice will be sent to the sponsor by June 30, 2005 (approximately 90 days). The sponsored study account should terminate no later than September 30, 2005. Total time from IRB/contract termination to account termination: 180 days.