The documents, generated by the HARMONIC consortium, can support other studies that need to collect and analyse data from patients treated for cancer, with the aim of promoting collaborative research and open science
One of the main achievements of HARMONIC has been the establishment of a cohort of more than 2000 children, adolescents and young adults treated with photon or proton therapy in Europe, whose data are now all collected in the same format in a functioning registry.
The HARMONIC consortium is now making the study protocol and database structure available to the wider scientific community who wish to collect data using the same format and protocol.
Shared resources for harmonised data collection
The study protocol consists of the scientific and technical documentation related to the implementation and conduct of the HARMONIC radiotherapy study in the participating centres, including the original language patient information forms and standard operating procedures.
The database structure and data dictionary consist of all the information needed to access and use the electronic Case Report Forms of the registry locally, via a secure, free web application called REDCap®. Please note that the implementation of the database structure does not include any connection to the HARMONIC Radiotherapy Registry itself or access to patient data.
Access
You can access the relevant application forms here.
Both the study protocol and the database structure can only be used in non-competitive, non-commercial projects and under the principle of preferential collaboration with the HARMONIC consortium.
Further information is available at https://clinicaltrials.gov (NCT04746729) and Journy et al. Radiother Oncol. 2024 Jan:190:109972. doi:10.1016/j.radonc.2023.109972.