Harriet Udd has been project manager for the development initiative Simplified agreement process. The initiative has recently been completed and in the interview below, Harriet tells about the outcome and what will happen next.
During execution of all types of clinical studies, the agreement process is a key issue regarding the conditions, rights and obligations of all parties involved. The agreement process has become more complicated in recent years as more parties are involved and an increasing proportion is foreign. We also have higher regulatory requirements, increased demands for faster agreement processes, and greater awareness of cost-effectiveness and cost-cutting. All in all, this creates a situation where the agreement process is often extended and there is a risk of delaying the start of the study. All parties involved need an increased understanding of processes with each other and especially researchers/clinics need support in the form of practical tools to facilitate and speed up the agreement process.
The aim of the development initiative was to visualize an agreement process as part of facilitating and shortening the process for researchers, clinics and industry.
The result of the project is a visual standardised agreement process with milestones, which is linked to various tools that may be useful in the various parts of the process. Another benefit and positive experience from the project is the transfer of knowledge between the regional nodes through their participation in the project team. The close cooperation has meant that the parties can help each other also in other matters. In addition, meetings with the reference group that consisted of all parties involved (Lif, AsCRO, Health and Academic) have also been very valuable. Long discussions have led to a better understanding of processes, needs and limitations.
Now we will start to work on spreading the project's results nationally, by training at least two people per regional node, who can then spread the knowledge further in a way each node and healthcare region find appropriate.
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