Faculty/Staff Effort Management for Clinical Research Studies

I. SCOPE

This policy covers all University faculty and staff who provide effort in support of the clinical research mission at Duke University.

II. POLICY

University faculty and staff working on clinical research studies must include appropriate effort during the budget/proposal development process and allocate effort appropriately throughout the life of the sponsored agreement to support accurate effort reporting in compliance with applicable federal regulations.

III. GUIDELINE

1. All effort performed on a clinical research study must be charged appropriately to the designated project.
   1. All University faculty and staff who perform research study related functions on a clinical research study (e.g. the PI, exempt staff employee, or hourly staff employee) should have an appropriate portion of their salary, representative of the effort performed, charged to the clinical research study (see Voluntary Uncommitted Cost-Sharing (VUCS) exception for faculty members in #4 below).
   2. Effort must be
      1. Reasonable
      2. Measurable
      3. Reflective of the university time expected to be performed on the study in the pre-award budget
   3. It is permissible for a faculty member to perform professional clinical services (patient care) for the clinical research study as part of his/her PDC effort.  In that case, the faculty member should bill for his/her services through the normal PDC mechanism. Patient care charges, with the prescribed rate, should be billed to either the clinical research study, patient or insurance as deemed appropriate.   Effort for these services must not be simultaneously charged to the study through the faculty member’s University effort.  In situations where the effort allocated to the study is meant to cover professional fees associated with clinical research patient care charges, the “MD Paid by Study” modifier should be used in Maestro.  This billing modifier “zeroes out” the professional charge so that the project, patient, or insurance is charged.

2. Each department must develop a method to 1) estimate (during study budget/proposal development) the amount of effort that will be required by each faculty/staff member on a clinical research study, and 2) monitor actual effort expended throughout the life of the clinical research study until closeout.

3. When determining the appropriate level of effort to budget on the clinical research study, the following factors, at a minimum, should be taken into account:
   1. Number of subjects to be identified, screened, and enrolled during the life of the clinical research study
   2. Amount of time required for start-up activity, training, regulatory oversight activities, and close-out activities
   3. Amount of time required to conduct study activities with research subjects
   4. For federal projects, there is an expectation for some level of committed faculty effort, paid or cost-shared.

4. If faculty university effort was not awarded but is later expended, this effort is considered voluntary uncommitted cost-sharing and does not need to be charged to the project.  However, the department/faculty member may elect to direct charge this to the project, subject to award terms.  If not charged/cost-shared to the grant, the salary/fringe costs associated with the effort must be “reserved” on another non-sponsored account.

5. For Industry Sponsored Clinical Research Studies, Duke will allow PI effort to be aggregated for clinical research studies on the Other Support page as long as budgeted and actual effort is less than 5% on each study. This mechanism will support compliance with internal and external regulatory requirements.  In SPS, a minimum of 1% effort for the PI must be reflected at the time of budget submission although during the life of the study actual effort expended by the PI must be charged directly to the study as incurred, minimally updated on a quarterly basis.

6. Departmental Grant Administrators/Managers or Financial Practice Managers are responsible for 1) the management and oversight of effort on sponsored projects, including payroll processing and monitoring of effort reports regularly, for departmental personnel and 2) verifying the reasonableness of “Other Support” activity when submitting proposals to the Pre-Award Offices.

Non-compliance with this policy may result in disciplinary action.

IV. ADDITIONAL RESOURCES

GAP 200.170, Effort Reporting

RCC Policy: Maximum Effort Funding on Sponsored Projects

RCC Policy: Timeliness of Certifying Effort

SOM Guidance: Industry Funded, Internally Contracted Clinical Research Activities with No Measureable Effort
*Note: Access requires user to have SOM permission.

Office of Sponsored Programs Liaison: 684-5442
Office of Research Administration: 684-5175
Office of Research Support:  684-3030

Note: This guidance is administrative in nature and is not a cost reimbursement policy. Failure to comply may or may not result in adjustments of charges to the award. Noncompliance with this policy does not mean this cost is unallowable from an external perspective. Any adjustments of charges will be as required under applicable Federal cost reimbursement principles. If a cost is removed from an award for any reason, whether or not related to this guidance, the cost will generally be charged to departmental funds.