Clinical Study Protocol

Last version of the clinical study protocol. The protocol is a document that describes the G-DEFINER clinical study objectives, design, methods, assessment types, collection schedules, and statistical considerations for analyzing the data.

Clinical Study CRFs
We have elaborated paper case report forms (CRFs),on the bases of which we have built the study eCRF (database), which allows to collect the clinical and gender data of the prospective study. we aim at exploring the irAEs incidence in relation to psychosocial and behavioral determinants. The study CRFs have sections dedicated to collection of gender characteristics, both at baseline (before starting immunotherapy) and during the treatment period.
Study SOPs
These Standard Operating Procedures (SOPs) are documents containing detailed written instructions relating to common or important tasks and practices of the G-DEFINER project. G-DEFINER adopted the SOPs with the aim to achieve efficiency, quality output and uniformity during study conduction.

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 741874.
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