Interim analyses as per the statistical Interim analysis reports UoB-CLN-STA-SOP-001 analysis plan Independent oversight of the trial: Evidence of meetings e.g. UoB-CLN-TQM-SOP-001 arrange regular meetings for oversight agenda, report to the committees e.g. Trial Steering Committee, meeting Committee, Data Monitoring minutes, follow up letter Committee IMP/medical devices: ongoing supply, Supply management UoB-CLN-IMP-SOP-001 return and destruction system, supply shipment, return and/or destruction forms Serious Breach investigations, where Serious Breach report, UoB-CLN-SBR-SOP-001 required evidence of submission of report to REC and CA (if required) Safety signal detection Annual Safety UoB-CLN-AES-SOP-001 Report/Development Safety Update Report, Data Monitoring Committee report
Interim analyses as per the statistical analysis plan Interim analysis reports UoB-CLN-STA-SOP-001 Independent oversight of the trial: arrange regular meetings for oversight committees e.g. Trial Steering Committee, Data Monitoring Committee Evidence of meetings e.g. agenda, report to the Committee, meeting minutes, follow up letter UoB-CLN-TQM-SOP-001 IMP/medical devices: ongoing supply, return and destruction Supply management system, supply shipment, return and/or destruction forms UoB-CLN-IMP-SOP-001 Serious Breach investigations, where required Serious Breach report, evidence of submission of report to REC and CA (if required) UoB-CLN-SBR-SOP-001 Safety signal detection Annual Safety Report/Development Safety Update Report, Data Monitoring Committee report UoB-CLN-AES-SOP-001
UoB-CLN-CTM-QCD-002%20Clinical%20Trials%20Task%20Delegation%20Log%20CI-CTU%20v1.0%20dd24-11-15.docx