FDA has introduced stricter requirements for safety reporting in clinical trials, which became effective in September 2011.
The purpose of this new rule is to:
- Clarify definitions of adverse events with regards to expectedness, relatedness and seriousness
- Use internationally acceptable definitions and standards
- Revise requirements for expedited reporting
- Clarify circumstances for unblinding ongoing study
- Clarify format and frequency of reporting
- Clarify FDA- and IRB-reportable adverse events to minimize “noise”
- Make BA/BE studies subject to IND safety reporting requirements.
