With the monitor being present at the site, he has the possibility to develop solutions in immediate reaction to observed problems or issues. Most importantly, he can actively involve the study team in this process. Consequently, the site staff might feel much more motivated to document flawlessly and to contribute valid data for a successful trial output. That is, rather than feeling under “remote control” and overpowered by sudden actions, the site staff is effectively in charge to optimize the processes in a close collaboration with the monitor for a smooth study course.
For example: Receiving assistance by the monitor at the resolving of queries, might result in an immediate training effect for the study team in order to prevent even more query load in the future. Moreover, the study team and the monitor can discuss issues or uncertainties that might have led to incorrect documentation and optimize the processes together. When a new staff joins the study team or when observing a non-compliance with the protocol, the monitor can initiate an immediate (re-)training or coaching at the site. Also the development of recruitment strategies can be a joint venture between the monitor (as mediator between the site and the pharmaceutical company) and the study team.
The site staffs’ input is not only valuable by itself but being involved also leads to highly motivated teams at the site and, thus, high-quality data and compliance in the end. And from these interactions between site personnel and monitor, the sites’ feedback can be provided to the sponsor in a structured way (i.e. in the monitoring report), and thus may lead to a learning also at the sponsor level (e.g. what is an useful immediate reaction to a certain issue, learning for future studies).