What is a PUC review?
PUC stands for 'protocol feasibility committee'. The PUC assesses the draft study documents for local feasibility before submission to the METC. The PUC review aims to assess draft study documents for local feasibility before submission to the METC. The goal is to identify local bottlenecks and points of interest, so that they can be anticipated at an early stage.
Examples of documents that are presented during a PUC review are protocol, patient information (PIF), patient diaries, pharmacy manual, lab manual, declaration form, etc.
Points of attention during the review
All feedback is very welcome during a PUC review. Points that should be particularly focused on are:
- Is the protocol, especially the chapters on treatment and study procedures to be followed, clear?
- Are there factors that could hinder patient inclusion?
- Is the PIF locally usable and understandable for patients? Are there any suggestions for changes? Please note: HOVON must draw up the PIF in accordance with the CCMO template.
- Are protocol and PIF in line with each other? Or are discrepancies seen?
- Are the additional actions described in the PIF consistent with the study? Does this correspond with local practice in your own hospital?
- Are the reimbursements stated in the declaration form sufficient?
- Is the study easy to start and carry out? Or are substantive and/or logistical bottlenecks anticipated?
Organization of the review
The PUC review is coordinated by the HOVON 'Trials & support' committee. They receive the draft study documents from HOVON, maintain contact with the review sites, collect all feedback and then coordinate this with the study team and the HOVON principal investigator.
2-3 participating sites are requested per study. Contact is via the local PI and research coordinator. If feasible, they may also involve supporting departments in the review. This is highly recommended!
The period for the PUC review is determined per study and is usually 2-3 weeks. The aim is to announce the PUC review well in advance.
Time investment of a review
Carrying out a PUC review takes time. Take 1 to 2 half days into account. However, it is an investment that pays for itself. Sites that review are more likely to be aware of the study and, partly due to their feedback, they will be able to start the study more easily and quickly later.
For more information about the PUC review, please contact the chairman of the HOVON 'Trials & support committee'.