Early Termination of Industry Sponsored Clinical Trials
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 the MCG IRB (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 Office of Grants and Contracts (OGC) with an effective termination date and information regarding the reason for early termination.
-
The Office of Grants and Contracts 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 MCGRI.
-
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.
Example:
PI terminates the IRB approval effective April 1, 2005. OGC 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.
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.
| Mission and Goals |
|
Division of Sponsored Program Administration |