What is happening in the development initiative: National collaboration regarding monitoring services
Maria Skoog has been the project leader for the development initiative on collaboration in monitoring. The initiative has now ended, and in the interview below she tells us what the work resulted in.
Why have we had a development initiative relating to collaboration in monitoring multi-centre studies initiated by academia?
Monitoring major, geographically wide-spread multi-centre studies is challenging. For monitors, it often involves many long journeys to the trial sites taking part in the study.
If several monitors with geographic connections to the different trial sites collaborate, you can benefit from their local knowledge, and their knowledge of the regional healthcare and the research rules that prevail. This collaboration creates local accessibility for the investigator. Collaboration also entails less travel, which is of benefit both to the environment and to the work load.
To date, a structure and a good working model for this type of collaboration between the nodes have been lacking.
The aim of the initiative was to develop a structure for collaboration in the monitoring of investigator-initiated multi-centre studies, where several nodes or healthcare regions are involved.
What was the outcome of the development initiative?
The initiative has delivered a “working model for collaborative monitoring”, consisting of a process description and supporting templates, specifically designed for monitoring work. The process description lists different roles and work elements, and specifies how the collaboration can most easily be carried out. The supporting templates will simplify and increase the efficiency of both the start-up of the co-monitoring and its implementation, as everybody will be working according to a common structure and using the same documentation. Collaborative monitoring is a supplement to traditional monitoring, where one monitor is responsible for all the trial sites. All studies are not suitable for collaborative monitoring, however. Factors such as the scope, complexity and geographical distribution of the study need to be taken into account.
The templates and support documents produced can be used by all who consider them a help when conducting a clinical study.
During the course of the work, many positive efficiency gains in the collaboration between the nodes’ monitoring functions have already been established. The project group was used for support and competence exchange regarding the situation that arose when the COVID-19 pandemic hit. This made it impossible to travel to trial sites; instead, monitors became dependent on local resources for monitoring and start-ups of studies.
What happens next?
A work team will be started, which will spend a couple of years on further work on implementing the process for collaborative monitoring.
Templates and support documents produced to date (in Swedish)
- Process and task allocation
- Assessment of monitoring degree
- Time estimate
- Monitoring plan
- Instruction for report template
- Initiating report
- Monitoring report
- Close-down report
Read more about:
- the development initiative National collaboration regarding monitoring services
- other development initiatives within the framework for Clinical Studies Sweden