You should be able to define the following:
- adverse events (AE)
- adverse reactions (AR)
- serious adverse events (SAE)
- serious adverse reactions (SAR)
- suspected unexpected serious adverse reactions (SUSAR)
For details please see:
This procedure must be followed for CTIMPs, but may also be used for clinical research studies.
If you require more specific detail you can prepare an additional departmental SOP.
CTRG staff are happy to provide basic training on safety reporting, but it is your responsibility to ensure that you fully understand this matter.