How to Start Effort Tracking at Your Clinical Research Site

Appy Ayyagari
September 8th, 2017

The value of tracking effort in clinical research is evident. Tracking effort enables you to better budget for future protocols, advocate for more staff and identify areas for process improvement. That said, many sites shy away from effort tracking due to the time and manual effort required. The idea of starting to track effort can be very overwhelming. Where do you start? What should you collect? How do you use the data? Outlined below are six simple steps to walk you through effort tracking implementation at your site.

1. Identify your goals

The first step in starting to track effort at your site is identifying your goals for the project. Ask yourself, what are we trying to accomplish with the effort data collected? There are many reasons for tracking effort—capturing start-up or study coordinator activities for budgeting, forecasting staff bandwidth for future protocols, or identifying areas of improvement for inefficient processes.

Whatever your reasons may be, compile a list of questions you want to answer with effort tracking data. This information is going to be useful in garnering buy-in from both your staff and your leadership.

2. Start small

Now that you have your list, pick one goal. It’s important to start small because not only does it make the task less overwhelming, but it also allows you to work through any kinks and build a solid foundation for rolling out effort tracking processes. Remember, once you have a solid framework for tracking effort, you can always add additional categories and tasks to track.

Starting small also allows you to quickly show effort metrics that answer the initial question. Sharing these metrics can help you gain buy-in and trust from your staff. To give you an example of the process, we will use the following goal: Obtaining quantifiable data that will enable budget justification for future study start-up costs for cardiology studies.

Find necessary steps to help you get started with effort tracking at your research organization in this free eBook. 

3. Define your scope

For each activity track:
  • Protocol #
  • Staff
  • Category
  • Time Spent

Now that we have a single goal to focus on, let’s delve into the specifics. First, set clear definitions for the scope of your effort tracking in terms of both activities and time. In this case, that’s start-up activities.

For this example, we’re going to define study start-up as the tasks involved from the time the protocol is received to the time it becomes open to enrollment. Define high level categories for the study start up process, such as budgeting and administration. Then, dive deeper into the categories to look at specific tasks associated with each one.” Start with a basic list of 3-7 categories and tasks you want to track. You can always add more as you get better at tracking effort. Keep in mind that it’s much harder to remove complexity than it is to add it. You could even start with just one category to get the process started. Below is a starting list of categories and tasks you may want to track for this particular purpose:

  • Administration
    • Assigning financial and regulatory staff for protocol
    • Initial Protocol Review
  • Budgeting
    • Initial Budget Construction
    • Negotiations
    • Financial Feasibility Review
  • Regulatory
    • IRB Submission
    • IRB Review
  • Protocol Training/Meetings
  • Sponsor Communications
    • Email
    • Phone

4. Communicate and implement

Once you’ve defined your scope, categories and tasks for which you want to track effort, a key element to setting yourself up for success is to clearly communicate the plan to your team.

Launch meeting

Set up a launch meeting for effort tracking where you communicate the goal, expectations and future accountability for tracking, and share the list of data elements and tasks that should be tracked. This would be a good time to give a demonstration of how to log effort within whichever tracking tool you are using. Be clear about the why and when you expect to be able to share initial insights. This will help create excitement and motivation among staff.

Cheat sheets

In addition to your launch meeting, it’s helpful to create some quick cheat sheets for how to categorize tasks and how to log effort, outlining what is a budgeting activity versus an administration activity. There will likely be several questions about categorizing activities, so providing as much help as possible ahead of time will allow staff to more readily track their effort. There are no hard and fast rules on how to categorize tasks but it’s important that once you’ve made a decision, it’s clearly communicated to your team and promoted consistently.

Follow through

It is critical to set up a plan for follow through. Is someone checking weekly to make sure effort is tracked? Is the actual task of tracking effort being worked into your staff’s workflows? Making sure there is follow through will help to keep you on track and get the most out of effort tracking.

One example of how you can help with follow through is to create scheduled reports for each of your staff members detailing their effort. It will help your staff to see how much they each contributed towards the total time spent on protocol coordination tasks in a given week. And, if they haven’t completed their logs, it will give them a gentle reminder!

Check out this infographic to learn more methods for successfully generating staff buy-in for effort tracking.

5. Review and Analyze

When you reach a critical mass for effort tracking data, which could be a time frame or a number of protocols, you can then employ that data for better visualization and insights into the amount of effort required for study start-up activities.

Be wary of “Analysis Paralysis”

When working with data, it is important to keep in mind that more data isn’t always good. Analyzing the perfect way to do things can get in the way of progress. Get started, look at initial results, and adjust from there, if needed.

Keep your goal in mind

As with every step laid out above, go back to your original objective and ensure your plan is set up in a way that will achieve your goal.

Keeping your goal in mind, you can plan for what outputs you are expecting and help you achieve them. If tasks get too granular or complex, or are not consistently tracked, for example, your ability to show this data to sponsors is limited, and your goal of justifying your budgets is less achievable.

Small decisions along the way will lead to the end result. Many times the devil is in the details, so keeping your goal at the forefront will help you and your team ensure that each small decision is in line toward meeting your objectives.

6. Report your progress

Seeing real results is motivating. For something that requires such consistency, ensuring staff are properly motivated is critical, especially for longer-term projects. Showing staff results like the graphs below, even if the data is not yet full or complete, will help them know they are part of an important project and their continued engagement is important.

In our example, our goal is being able to utilize data for future budgeting, focusing on study start-up activities for cardiology studies. Here is an example of a graph you could pull out of your effort tracking data to easily visualize numbers of hours per protocol.

Start-up Effort by Protocol

Since you included additional tracking elements like category and coordinator for each activity, you can also manipulate the data to see what percentage of time is spent per category across protocols.

Staff Effort by Category

Summary

In summary, you can gain insight into the time your staff spends on certain activities. The key is to clearly identify your objectives, start small, stay focused, communicate, and report back your results.

Learn more about why and how to start effort tracking at your site in Forte’s free eBook, “How to Conduct Valuable Effort Tracking at your Site.” Download your copy today.

Editor’s note: This article was originally published on April 10th, 2015.

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