10.2 Trial Management Group Trial Management Terms of Reference or Charter, list of members and signed agreements from each Group (TMG), member Independent Data Monitoring Agenda, papers and correspondence relating to all meetings Committee (IDMC) Trial Steering Group and Trial Steering Terms of Reference or Charter, list of members and signed agreements from each Committee (TSC) member Agenda, papers and correspondence relating to all meetings Independent Data Monitoring Committee Charter, list of members and signed agreements from each member Agenda, papers and correspondence relating to all meetings IDMC reports, including interim reports required for the statistical analysis 10.3 Trial delegation log for main study team Main study team training CVs and GCP training Training log for main study team Study-specific training 10.4 Sponsor’s documented annual verification of the trial records held on EDGE Verification of trial records (EDGE) 10.5 Trial newsletters General communications
10.2 Trial Management Group (TMG), Independent Data Monitoring Committee (IDMC) and Trial Steering Committee (TSC) Trial Management Group Terms of Reference or Charter, list of members and signed agreements from each member Agenda, papers and correspondence relating to all meetings Trial Steering Group Terms of Reference or Charter, list of members and signed agreements from each member Agenda, papers and correspondence relating to all meetings Independent Data Monitoring Committee Charter, list of members and signed agreements from each member Agenda, papers and correspondence relating to all meetings IDMC reports, including interim reports required for the statistical analysis 10.3 Main study team training Trial delegation log for main study team CVs and GCP training Training log for main study team Study-specific training 10.4 Verification of trial records (EDGE) Sponsor’s documented annual verification of the trial records held on EDGE 10.5 General communications Trial newsletters
tmpl_043_ctimp_trial_master_file_contents_index_v2.0_09.04.18.docx