[Q&A] Assess Clinical Trial Staff Workload and Maximize Site Performance

April Schultz
June 21st, 2018

During our recent webinar Assess Clinical Trial Staff Workload and Maximize Site Performance, Dr. Suzanne Rose, Director of the Office of Research at Stamford Hospital, discussed the tool she developed to assess staff workload, allocate study resources and reduce the potential for staff turnover. Here, Suzanne answers attendee questions on regulatory workloads, managing multiple coordinators and more. 

dgfrg Do you know if similar workload assessment has been done for research Regulatory workloads? 

To the best of my knowledge after an extensive literature search, there is not a workload assessment tool for Regulatory Coordinators. A recent ASCO document indicated they are working on this type of tool, as is my site, but to date, published data has not yet been made available. Two papers that have been published on the topic from a time tracking perspective for regulatory coordinators are below and definitely worth reading for an understanding of how much time is spent per trial type.
 
J Natl Compr Canc Netw. 2011 Nov;9(11):1228-33.
Creating an effort tracking tool to improve therapeutic cancer clinical trials workload management and budgeting.
James P1, Bebee P, Beekman L, Browning D, Innes M, Kain J, Royce-Westcott T, Waldinger M.
 
J Natl Compr Canc Netw. 2011 Dec;9(12):1343-52.
Effort tracking metrics provide data for optimal budgeting and workload management in therapeutic cancer clinical trials.
James P1, Bebee P, Beekman L, Browning D, Innes M, Kain J, Royce-Westcott T, Waldinger M.
 

 How is the scale affected if multiple clinical research coordinators (CRCs) are working on the same study? For example, there are six subjects enrolled but one CRC is responsible for three subjects and the other three are handled by another CRC.

The workload tool can easily handle this. If the work is completely separate from coordinators, they would both be ‘primary’ coordinators on the study and the study would appear in each of their spreadsheets with them then also given appropriate weights as ‘back-up’ coordinators for the subjects they are not following as primary coordinator. We currently have this situation at our site and the tool does a great job tracking the work appropriately as the coordinators are following different subjects on the same study.

 How many coordinators do you score and what is time involvement monthly to keep scores up to date? 

Currently, we have six full-time coordinators and it takes me 15 minutes a month to keep the scores current. We have bi-weekly meetings where all study enrollments, screen failures, study completions and deaths are discussed. In addition, we keep record of when a study is in pre-study (site awarded study) to study being open to study closure and long term follow-up.

 Do you make this information public so that all staff can see each others scores?

Currently, this information is not provided publicly. From previous experience, it can cause tension amongst the coordinators. However, from discussions with another site with a similar scoring tool, the suggestion is to provide the coordinators with the knowledge that they are either at, above or below the benchmark, which is a great compromise and one we will implement at our site for mid- and end of the year reviews.

Want more answers? 

Watch the free, on-demand webinar, Assess Clinical Trial Staff Workload and Maximize Site Performance, to learn more about how a workload tool can provide greater insight into coordinator performance and help you determine where to allocate studies and resources. Watch the recording today!

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