Coordinated Monitoring Saves Time, Money, and Carbon Dioxide

Monitoring a clinical research study often requires many long trips within and outside of Sweden. Therefore, in 2018, Clinical Studies Sweden initiated a development effort that marked the beginning of a new type of Coordinated Monitoring. With Coordinated Monitoring, a coordinating monitor receives assistance from colleagues across different regions.

Bild föreställande Margareta Scharin Täng och en bild på en skrivbok med penna

The working group for Coordinated Monitoring is a concrete example of how Clinical Studies Sweden provides support to those conducting clinical studies in healthcare. The group consists of seven monitors from the six healthcare regions and was established in response to the need for Coordinated Monitoring.

Margareta Scharin Täng, quality coordinator and monitor at Gothia Forum, explains: ‘The need arose for us at Gothia Forum when we received a study request that we couldn’t carry out with our existing personnel resources. Since there is a significant shortage of monitors in general, especially within academic research studies, we wanted to test Coordinated Monitoring. Our first project using Coordinated Monitoring is nearly complete, and it has worked excellently.’

Crossing Regional Boundaries

One of the challenges was how the working group would adopt a consistent approach across all regions. The initial step involved creating shared templates and support documents to facilitate collaboration when multiple monitors work on the same project, including monitoring plans and report templates.

Margareta Scharin Täng adds: ‘Since each region previously had its own templates and documents for monitoring procedures, we began by reviewing these different documents and determining how they could be merged. Now, there is strength in having all regions use the same templates and logs. The key is that the coordinating monitor keeps everything organized.’

The templates and logs developed in the project are freely available for anyone to use and can be downloaded from Clinical Studies Sweden’s website.

– Coordinated Monitoring benefits everyone involved. By supporting each other within the regions, individual monitors avoid many round-trip journeys within Sweden. This cost-saving approach benefits sponsors by reducing travel expenses and hotel nights. Additionally, regions can take on more monitoring assignments, says Margareta Scharin Täng, quality coordinator and monitor at Gothia Forum.

The Process

Traditionally, a monitor is hired to oversee a clinical research study, regardless of the number of study sites. Much of the monitor’s time is spent traveling between various hospitals in Sweden and potentially other European countries.

In Coordinated Monitoring, a ‘lead monitor’ is appointed to coordinate the work of other monitors. The coordinating monitor sends requests to other nodes in Sweden’s regions to determine who can participate. These requests typically include a synopsis and an estimated time for local monitoring.

For a comprehensive description of the process, you can find the document ‘Process Description and Work Distribution for Coordinated Monitoring with a Coordinating Monitor’ on Clinical Studies Sweden’s website."

You can access the document on the following page:

Mallar för samverkans­monitorering