Ethics approval and consent to participate
ICH
RECRUITMENT, APPENDIX
The clinical trial is conducted in conformity with:- Ethical principles stated in the Declaration of Helsinki 1964, as revised in Fortaleza, 2013- The European Directive (2001/20/EC and 2005/28/EC)- Directive 95/46/CE on the processing of personal data- Appendix 13 of the E. U. Guide to Good Manufacturing Practices (revised and adopted in February 2010 by the European Commission),- The Good Clinical Practices guidelines (International Conference on Harmonization ICH E6) and Statistical Principles for Clinical Trials (ICH E9),- The Clinical Safety Data Management guidance (ICH E2A), and- Any local Regulations including○ French Public Healthcare Law (n° 2004-806) of August 9, 2004, a partial adaptation of the European Directive (2001/20/EC) on the conduct of clinical trials,○ French Public Healthcare Law (n° 2016-41) of January 26, 2004, about modernization of the health system,○ Ordinance n°2016-800 of June 16, 2016, on medical research involving human subjects,○ French Informatics and Liberties Law (n° 78-17) of January 6, 1978 modified by Law n° 2004-801 of August 6, 2004, relative to the protection of physical persons with respect to the treatment of personal information,○ French Law n° 2002-303 of March 4, 2002, relative to patients’ rights and to the quality of the healthcare system.The first act of recruitment (i.e., start of the clinical trial) is defined as being of the first site initiation visit.The first visit of the first subject is defined as being the date of signature of the consent form by the first patient, i.e., first inclusion in the trial.The end of the trial is defined as being the last-protocol-specified visit of the last patient, i.e., 5 years after randomization for the last patient.This protocol was submitted to the French National Research Ethics Committee (CPP IDF 2) which gave its approval on 13/02/2018 (annex Gustave Roussy has taken out a legal liability insurance policy (N°124.895) (annex A clinical study report on the trial will be written at the latest, 1 year after the end of the trial. Results will be sent to the competent authority and to the Ethic Committee.Results of the long-term follow-up might be available in medical publication format after availability of the Clinical Study Report.Gustave Roussy will maintain records of essential trial documentation in the Sponsor file for a minimum duration of 15 years after the end of the trial.It is the responsibility of the investigator to obtain a signed informed consent from each patient (or his/her legal representative when required) prior to participating in this study. Consent should be obtained before any study-related procedure and after adequate explanation of the aims, methods, anticipated benefits, potential hazards, and requirements imposed by the study.The patient / legal representative will be provided with an information and consent form in comprehensive, clear, relevant, and simple language. Adequate time shall be given for the patient (or his/her legally designated representative) to consider his/her decision to participate in the clinical trial. Patient (or his/her legal representative) should be informed about his/her right to refuse to participate and the right to withdraw from the trial at any time without any resulting detriment and without having to provide any justification.Having read the information notice, the patient (or legal representative) must date and sign the consent form if he/she accepts to participate. This consent form must also be signed by the investigator. The original consent form must be kept in the study file by the investigator and the study participant (or his/her legal representative) should receive a copy.During a patient’s participation in the trial, any update to the consent form and any update to the written information will be provided to the patient.