The Swiss NutriAct App is part of a multi-center clinical study.
- This study will be conducted in compliance with the protocol, the current version of the Declaration of Helsinki, the ICH-GCP, the Swiss-HRA as well as other locally relevant legal and regulatory requirements.
- The study protocol is approved by the local ethics committee.
- All study participants need to sign an informed consent form at the study center and will only be registered to the app once this has been completed.
- The data collected in this trial will be kept confidential. At each center the data and all corresponding documentation regarding the study, electronic and otherwise, will be kept in a controlled access area. Access will be controlled by the responsible clinical investigator.
- All data contained in the database is pseudonymised. A subject identification list will be maintained at each center. The pseudonym assigned to a subject will be a running number within the center.
- The data collected by the application (Swiss NutriAct) will be stored on a dedicated server in Switzerland and is kept in a controlled access area. Access will be controlled by the responsible clinical investigator. All data contained in the database of the application is pseudonymised.
- After completion of the data collection, the pseudonymised data from the application (Swiss NutriAct) will be transferred to secuTrial® by the study team and subsequently deleted from the server of the application.
Prof. Dr. Miklos Pless
Chefarzt Medizinische Onkologie, Departement
Medizin, Kantonsspital Winterthur
Brauerstrasse 15, 8401 Winterthur, Switzerland
Miklos.Pless@ksw.ch, +41 522 266 3640
The study has been published in a study registry on clinicaltrials.gov
Last revision: June 2021