Clinical Trials Office Time and Effort Tool
From Business Intelligence
Contents |
[edit] Project Contact
If you have questions or would like more information, please contact Pam James, (pajames@umich.edu).
[edit] Project Description
The Clinical Trials Office has developed a Time and Effort Tool, which identifies how much FTE time is related to a study. The office also developed a tool that measures study complexity, which enables accurate estimates of staffing needs and study costs.
[edit] Business Need
- Determine the amount of time an FTE is dedicated to study-related work and the amount dedicated to non-study-related tasks, such as staff meetings or sick and vacation time.
- Measure variations in the complexity of research protocols that can translate into increased workload for Clinical Trials Office staff
- Inform negotiations of study budgets to ensure inclusion of costs that were not previously covered.
- Provide hard data regarding staff utilization in response to requests from investigators, programs and cancer center leadership.
- Accurately bill for the services pertaining to studies.
- Identify possibilities for eliminating waste.
[edit] Project Purpose, Scope, & Deliverables
- Track the time staff spends on each study to which they were assigned.
- Provide data to the Clinical Trials Office finance group, the principal investigators and others involved in the research study for the purposes of accurately billing each study for the time required to complete it.
- Measure the complexity of various aspects of a study to determine the work capacity of staff, and adjust staffing or workload accordingly.
- Evaluate the current NCI standard, which states that a full-time employee should be able to enroll 30-40 brand new patients in clinical trials each year, to determine if that standard is reasonable.
[edit] Audience/Users
- Clinical Trials Office finance group
- Principal investigators
- Others involved in research studies
[edit] Duration/Timeline
The Clinical Trials Office implemented the Time and Effort Tool approximately three years ago. More recently, a pilot implementation of the Study Complexity Tool with approximately 40 studies validated the resulting data. The office intends to publish this model in an effort to influence the NCI and national standard currently used to determine staff workload.