Research Newsletters

Assigning PI Effort to Clinical Trials

by Deb Vetter, Director of Sponsored Programs Administration

SPA’s practice to require principal investigators (PI) to devote measurable effort on sponsored projects may create problems when budgeting for clinical trials. SPA’s directive is to assign PI effort to each sponsored project, with the minimum being 1%. Clinical trials, on the other hand, may require only a small amount of PI effort. Often the PI’s effort on a clinical trial is dependent on patient enrollment. Therefore the practice of charging PI effort for “the life” of the project may not align with the timing of the PI’s contribution.

To accommodate, SPA will accept less than one percent effort for industry-sponsored clinical trials and invites units to consider using one percent for one or more quarters. For example, if a PI earns an annual salary of $100,000, devoting one percent effort over one quarter (0.25 percent effort) would equate to $250, a surprisingly small amount. For this reason, SPA encourages the research team to consider the scope of work and required duties—e.g., protocol oversight, CRF review, adverse event review—in estimating the necessary level of effort.

One of the duties of the research coordinator is to translate the sponsor’s budget to “communicate” with our accounting system using SPA’s internal budget form in ADIS. The Personnel category of the internal budget lists the effort required for the PI to administer the trial. Whether the study recruits 5 or 50 patients, the PI effort would not change significantly. Some physician PIs also treat patients as part of the clinical trial. In this case, the professional fees associated with the research related patient care costs may be charged to the sponsored project. Patient care cost (pro fees) are then captured as an operating expense on SPA’s internal form. Unlike personnel costs, these operating costs will significantly increase if the study recruits 50 as opposed to 5 patients.

Finally, SPA advises that you wait to charge the PI’s salary to the project until they are investing time. Should Sponsored Programs Accounting call (as a compliance check that PI effort is being charged), it’s appropriate to tell them that we need to wait until patients are enrolled before salary is applied to the project.

To summarize: PI effort is required whether or not salary is paid, use less than 1 percent effort if adequate, wait until the PI is devoting effort to the project before charging salary in SAP.

Contact Deb Vetter in Sponsored Programs Administration if you have questions.

 

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