Toxicity Scheme
| Field Name | Definition | Requirement Entry Instructions |
Responsible for Entry | QA |
|---|---|---|---|---|
| Toxicity Scheme | The Toxicity Scheme identifies the version of the Common Toxicity Criteria (CTC) that is used for classifying each Adverse Event (AE) and Serious Adverse Event (SAE) entered for protocol subjects. The coding scheme selected affects the Toxicity choices in the Subject Console > SAEs. | Required Ensure you are selecting the correct version because after a subject within the protocol has toxicities tied to them, the toxicity scheme cannot be changed. This field is required if the study is tracking toxicities or serious adverse events. |
PC Console edit / Protocol Coordinator | No |