Published June 21, 2016 | Version v1
Other Open

STRIDER UK: Independent Safety and Data Monitoring Committee (ISDMC) Charter

  • 1. University of Liverpool
  • 2. University of Leicester
  • 3. St. Georges Healthcare NHS Trust
  • 4. St. Mary’s Hospital Manchester
  • 5. Cork University Hospital

Description

This ISDMC charter defines the roles and responsibilities of the Independent Safety and Data Monitoring Committee (ISDMC) for the STRIDER UK trial, explains the ISDMC’s relationship with other trial committees, provides details of the ISDMC membership and describes the purpose and frequency of its meetings. This charter also describes the procedures for ensuring confidentiality and proper communication, the statistical monitoring guidelines to be implemented by the ISDMC, and an outline of the content of the Open and Closed Reports that will be provided to the ISDMC for each meeting.

Files

SSSTR_D005.2_-_STRIDER_Independent_Data_Safety_Monitoring_Committee_Charter.pdf