Data Safety - continued
3) Provide relevant materials to DSMB members prior to the meeting including reports, presentations and other relevant material, including confidential unblinded tables and reports from data files.
Biostatisticians who are involved in preparing unblinded material for DSMB members should have no direct involvement with the study. They may or may not be different than the official independent DSMB statistician.
At ICON, Biostatisticians have extensive experience of being both members of DSMBs and with establishing DSMBs.