50937 Cologne Germany Data Monitoring Committee Definition and description of the tasks and working methods of the Data Monitoring Committee (DMC): checking of trial progress, safety data, checking of efficacy variables, for example as part of a blinded interim analysis, advising the sponsor on the continuation, modification or termination of the clinical trial based on interim results or safety results (see also Guideline EMEA/CHMP/EWP/5872/03 Corr). This paragraph should include the description of information and data pathways. In case the DMC is involved in the reporting procedure (unblinding) for adverse events, this has to be taken into account (detailed description in Section 7.3.6). Be aware that a DMC is independent and therefore can have its own charter which determines its working procedures. (see also EMA on Data Monitoring Committees”, “Guidline EMEA/CHMP/EWP/5872/03). If appropriate, the reasons why a DMC is not considered necessary should be given here. A Data Monitoring Committee made up of independent experts will be set up. It consists of two physicians and a statistician who are not involved in the conduct of the trial and independent from the sponsor (see Section 11.4). The task of the DMC is to monitor the safety of the trial subjects in the clinical trial by periodically assessing the safety and efficacy of the trial therapy, and to monitor the integrity and validity of the data collected and the conduct of the clinical trial. Throughout this process of surveillance, the DMC provides the sponsor with recommendations with regard to continuing the trial (e.g. termination or modification) based on the data collected. The data necessary for the DMC to fulfill this function are provided by the sponsor as determined by the DMC. Amongst other datasets, these must include listings providing information on serious adverse events and further variables that the DMC considers necessary at least every 6 months and when formal interim analyses are conducted. Further committees This chapter and its subchapters are optional.
50937 Cologne Germany Data Monitoring Committee Definition and description of the tasks and working methods of the Data Monitoring Committee (DMC): checking of trial progress, safety data, checking of efficacy variables, for example as part of a blinded interim analysis, advising the sponsor on the continuation, modification or termination of the clinical trial based on interim results or safety results (see also Guideline EMEA/CHMP/EWP/5872/03 Corr). This paragraph should include the description of information and data pathways. In case the DMC is involved in the reporting procedure (unblinding) for adverse events, this has to be taken into account (detailed description in Section 7.3.6). Be aware that a DMC is independent and therefore can have its own charter which determines its working procedures. (see also EMA “Guidline on Data Monitoring Committees”, EMEA/CHMP/EWP/5872/03). If appropriate, the reasons why a DMC is not considered necessary should be given here. A Data Monitoring Committee made up of independent experts will be set up. It consists of two physicians and a statistician who are not involved in the conduct of the trial and independent from the sponsor (see Section 11.4). The task of the DMC is to monitor the safety of the trial subjects in the clinical trial by periodically assessing the safety and efficacy of the trial therapy, and to monitor the integrity and validity of the data collected and the conduct of the clinical trial. Throughout this process of surveillance, the DMC provides the sponsor with recommendations with regard to continuing the trial (e.g. termination or modification) based on the data collected. The data necessary for the DMC to fulfill this function are provided by the sponsor as determined by the DMC. Amongst other datasets, these must include listings providing information on serious adverse events and further variables that the DMC considers necessary at least every 6 months and when formal interim analyses are conducted. Further committees This chapter and its subchapters are optional.
Trial_Protocol_Template_V08.docx