In line with ICH E9 and E9(R1), the sponsor should prepare a statistical analysis plan consistent with the protocol unless the protocol covers the analysis, apply documented QC to statistical programming and analysis (for example sample size, IDMC outputs, report outputs, statistical monitoring), keep data transformations and derivations traceable, pre-define inclusion and exclusion criteria for analysis sets with documented reasons for any exclusion, allow deviations from the plan or data changes after unblinding only exceptionally with justification, investigator authorisation, audit trail and reporting in the trial report, and retain dated, time-stamped, change-protected, access-controlled programs and outputs. It should retain its essential records as regulation requires, tell investigators and providers in writing of retention requirements and when records are no longer needed, report transfers of record ownership to authorities and tell investigators if sponsorship changes, and ensure the protocol or an agreement provides for direct access to source records for monitoring, audit, inspection and IRB/IEC review and that participants have consented to it.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.