Official websites use .gov
A
.gov website belongs to an official
government organization in the United States.
Secure .gov websites use HTTPS
A lock (
) or https:// means you've safely
connected to the .gov website. Share sensitive
information only on official, secure websites.
Recording and reporting guidelines for notables AE/AR
| Individual AE | Aggregated AEs | |
|---|---|---|
| Who reports | Site Researcher | CTU |
| How it is reported | AEs eCRF |
Safety Report (SR) and Development Safety Update Reports (DSURs) |
| Timing | 7 days since knowledge |
6-monthly (SR) Yearly (DSURs) |
| Whom | Central CTU |
SR: DSMB - 6 monthly DSUR: EDCTP, Regulatory authorities, Ethical boards - yearly |
