Clinical Trials

The purpose of this procedure is to achieve consistent treatment of funds that are received from private companies for research studies associated with clinical trials.  These typically include specialized clinical testing.  If a research study is an adjunct to a trial involving human subjects, and if the study involves testing that is done in a clinical area and involves human samples, it should be handled by the Center for Clinical Studies. The department will not be allowed to claim the space as research space; it must be reported as clinical space. The department would have to build in reimbursement for space and administration into their fees. The rates on these studies is 20% of revenue, and the overhead would be taken at the time the revenue is received. This is the same rate that is used for research core facilities that are not related to clinical trials.

If a study does not meet the criteria above, it would be handled by the Office for Technology Management, and they would decide if it meets the tests for sponsored research. If they decide that it is sponsored research, they will notify the department and forward the agreement to Grants and Contracts. If they decide it does not meet the tests for sponsored research, they will notify the department and forward a summary to Medical School Finance, Resource Planning and Analysis.

Distribution and Use of Residual Funds