As you know, beside the VHP procedure, we have another burning ongoing activity which is the preparation of documents to submit to local CA and EC once the go obtained from VHP. Among the documents to prepare, our ECRIN partners are translating and adaptating the ICF to the local requirements. In order to be as complete as possible, could you please confirm if you will provide a compensation package to the enrolled patients?
For instance, in Belgium, Prof. Balligand dedicates a budget to a participation to travel costs and lunch. So, in the Belgian ICF, you can find:
Costs associated with your participation
This trial is funded by the EU Framework program for Research and Innovation, Horizon 2020.
By participating in this clinical trial, you will not have any additional costs due to investigational/diagnostic procedures or cost of medication, which will be free to you.
The sponsor has arranged to offer you a compensation fee for the costs incurred during the trial visits (travel/parking/light meal). There is a set fee foreseen of 10€ for the screening visit and 15€ for the following visits: Baseline, Month 1, Month 3, Month 6, Month 9 and Month 12. Contact the investigating team for the practical arrangements.
That makes 100€/patient or 3300€ for the study. This is not mandatory but we think that, if you can afford this, it can really be a big incentive for the enrolment of patients. As this must be stated in the ICF, Could you please contact your local ECRIN partner so he knows how to phrase the allowance or the non allowance of this package in your local ICF?
Thank you in advance for considering this and for the follow up actions.