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I saw in a risk document that CTCAE was utilized to categorize potential Harm into different severity levels.
Protocol Development | CTEP
| Cancer |
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| Protocol Development | CTEP |
| NCI has set Fall 2022 as the anticipated publication date for the next version of CTCAE (version 6.0). These next two years will be utilized to analyze change requests and create revisions. Your input is valuable and will help make CTCAE a better tool. |
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The standard was developed to describe the severity of organ toxicity for patients receiving cancer therapy. So a first look, it is odd that it is used in a medical device risk document. However, I can't rule out that it may still apply as there are general codes to describe harm.
Any inputs on the above are welcome