Table 2 Aspect of study and level of risk assigned
Aspect of study | Level of risk | Action |
|---|---|---|
Screening tools for sites | Low | One study statistician created the tools |
Reports of clinic data | Low | One study statistician produced the report |
Reports of e-diaries | Low | One study statistician produced the report |
Randomisation scheme | Medium | Two statisticians (one study statistician blinded when the randomisation scheme was produced created the test randomisation scheme, and one unblinded independent statistician produced the final randomisation scheme) |
DMSC/TSC reports | Medium | Both study statisticians worked together to create the report |
Preliminary report for DHSC | High | Both study statisticians created all tables and figures for report |
Derivation of outcomes | High | Both study statisticians derived all outcomes independently and compared derivations |
Modelling of outcomes | High | Both study statisticians analysed all outcomes independently and compared results |
Final report for DHSC | High | Both study statisticians created all tables and figures for report |