In a previous article, “Time is Money: Making the Time to Document the Time it Takes You to Conduct Research,” we made the case for documenting work effort as a way of demonstrating fair market value and aiding budget negotiations. In this article, we expand on the concept of workload planning to enhance staff efficiency.
Why track work effort?
Workload planning can address trial-specific questions such as, how much time and effort will it take to implement a given trial and do we have capacity to take an additional study on at this time? At the broader level, workload planning and management can address larger staffing and productivity issues, such as:
- How many trials can we handle?
- How can we maximize our efficiency to take on more trials?
- Who needs to be involved in the trial and how can I allocate my staff most efficiently?
- Where should my staff focus their time?
- How can we optimize the implementation of the trial to enhance compliance as well as efficiency?
Beyond providing evidence to support adequate clinical trial budgets and maximizing staff productivity, getting a handle on workload is important for developing staff performance expectations, ensuring that workload is manageable and mitigating staff burnout and turnover.
Learn the steps to start an work effort tracking program at your organization. Download our free eBook, “How to Conduct Valuable Effort Tracking at Your Site.”
The last ten years have witnessed more sophistication in workload planning approaches in clinical research, although we are still in our infancy compared to many other industries, such as manufacturing where these practices have long been established. As protocols become more complex, it’s even more critical to understand the impact they have on staff resources. Understanding workload is a function of:
- The total number of staff available
- The number of hours the staff is already committed to
- The total number of patients needed for the studies and their associated accrual rates
- The number of staff hours required for direct, indirect and non-protocol related activities
Time and Motion study
The gold standard for determining work effort is a Time and Motion study. Work sampling studies are also done but involve more effort and investment. Essentially a Time and Motion study involves staff prospectively documenting the time spent on specific tasks over the course of a pre-defined period, say 1 week or 1 month. Every 15-20 minutes, staff stop and record the work they were doing according to a specified list of activities that can involve protocol and non-protocol related activities. The total amount of work is then determined by multiplying intensity of the task (time involved) by the volume (frequency with which the task is performed). For example, let’s say one task is specimen management (obtain, process and ship blood samples). After staff collect this, an average estimate of time for this task is deemed to be 30 minutes. If the site processes 10 samples/week on average then the work effort would be 30 minutes X 10 specimens/week = 300 minutes or 5 hours per week allocated to this task. This is done for all staff time in order to come up with benchmark estimates of the average time involved for low, moderate and complex trial activities. In addition, a picture of the percent of time staff spend on trial-related versus other educational and administrative activities emerges.
From here you can create more realistic budgets and run some “what if” scenarios to see how accrual volume and enrollment rates may impact current staff capacity.
Related article: How to Start Effort Tracking at Your Clinical Research Site
Standardizing the definitions of the activities and tasks is key to creating an accurate assessment of workload. Furthermore, having standard data collection tools to capture the information and ensuring staff are well trained on these tools are other important aspects of a well implemented Time and Motion study. Tools that automate this process such as CTMS systems and mobile devices help to ease some of the burden of documenting work effort.
To learn more about effort tracking, watch our on-demand webinar, “Work Effort Tracking and Management Revisited: The Need, the Value and the Process.”
Editor’s Note: This blog post was originally published on February 5, 2013.