New procedure PUC review

Recently, a new method for the PUC review has been implemented. PUC stands for 'Protocols Executability Committee'. The aim is to determine whether a new HOVON study is feasible locally. This is done by reviewing a number of study documents from participating hospitals prior to submission to the EC. Examples of this are protocol, patient information, manuals for pharmacy and laboratory, nursing protocol, declaration form and, since 1 November 2021, also the VGO (Declaration of Suitability Research Institution).

In the new procedure, two study teams from hospitals that are going to participate in the study are approached who have registered for this via the feasibility survey. They are asked to carry out the PUC review, focusing primarily on local feasibility. Are protocol and patient information clear and useful? Are the different documents in line with each other? Are problems expected with local startup or testing? Are there bottlenecks that affect inclusion? These are all points of attention that will determine the successful course of the study.

A PUC review takes time. In practice it will be a few hours. However, it is an investment that pays for itself. In the case of a review, the local study team immerses itself in the study at an early stage and has the opportunity to point out any bottlenecks. This makes the study easier and faster to start.

With the implementation of the new working method, it was decided to abolish the old PUC committee and to transfer the PUC review to the Trials and Support working group, which already had many similarities.

Click HERE for the new procedure PUC review.