Table 7 Recording and reporting guidelines for SAEs
Individual SAE | Deaths | Aggregated SAEs | |
|---|---|---|---|
Who reports | Site Researcher PI | Site Researcher PI | CTU |
How it is reported | AE CRF An email | AE CRF An email Collect all the related clinical information | Safety Report (SR) and Development Safety Update Reports (DSURs) |
Timing | 24 h since awareness | 24 h since awareness | 6-monthly (SR) Yearly (DSURs) |
To Whom | CTU | CTU Ethical boards | SR: DSMB - 6 monthly DSUR: EDCTP, Regulatory authorities, Ethical boards - yearly |
Who decides the relationship with IMP and expectedness | Site researcher opinion Confirm by CTU | Site researcher opinion Confirm by CTU DSMB | CTU DSMB |