Plans for assessment and collection of outcomes
toxicity, ICH, CRF
CRF
The Biostatistics and Epidemiology unit at Gustave Roussy will implement electronic CRF (eCRF) using adequate software, thus allowing safe online direct data collection. Quality of life questionnaire will be completed using paper questionnaire.Each user will have personal identifiers (user ID / password), and data access will be strictly limited according to profiles.For each patient included in the trial, the eCRF will have to be completed by the hospital CRA and signed by the investigator or the person designated by the investigator.The study can be interrupted or terminated by the sponsor at any time in agreement with the coordinating investigator. Reasons may include, but are not limited to, the following:Frequency and/or unexpected severity of the toxicity,If any information leads to doubt as to the benefit/risk ratio of the clinical trialRecruitment of patients too low,Poor quality of the data collectedThe Sponsor has the possibility to replace a site at any time. Reasons for replacing a site may include, but are not limited to, the following:Slow recruitmentPoor protocol adherence / serious breach to the protocolInaccurate or incomplete data recordingNon-compliance with the International Conference on Harmonisation (ICH) guideline for Good Clinical Practice.The Sponsor can temporarily or permanently discontinue an investigator for participation in the clinical trial at any time. Reasons may include, but are not limited to, the following:Poor protocol adherence / serious breach to the protocolMajor deviation from the protocolNon-compliance with the International Conference on Harmonisation (ICH) guideline for Good Clinical Practice.Serious breach is defined as any conditions, practices, or processes that adversely affect the rights, safety, or well-being of the subjects and/or the quality and integrity of data.Major deviation is defined as any conditions, practices, or processes that might adversely affect the rights, safety, or well-being of the subjects and/or the quality and integrity of data.Minor deviation is defined as any conditions, practices, or processes that would not be expected to adversely affect the rights, safety, or well-being of the subjects and/or the quality and integrity of data.