t TITANIA
on

 

As a sponsor, we collect a separate AE when the severity changes, both worsening and improvement. This becomes especially tricky in the event of worsening, because per FDA rule SD1332, the outcome for the initial event cannot have a value of not recovered/not resolved.  If an end date is not entered, then we will potentially have events with overlapping dates. 

The CDASH User Guide has an example CRF which directly contradicts rule SD1332 (see attached image), therefore I am wondering if changes to this rule are being considered or what other options can be implemented to avoid triggering this check downstream.

The Outcome of Adverse Event (AEOUT) variable is populated with the value NOT RECOVERED/NOT RESOLVED, however the End Date/Time of Adverse Event (AEENDTC) variable is populated with an end date for the adverse event. If the adverse event has an outcome of NOT RECOVERED/NOT RESOLVED, it is expected that no end date is available.

Forums: General Discussion

Sergiy
on May 4, 2020

Hi Titania, 

SD1332 is implementation of FDA rule. Most Adverse Events data collected as one record per event. Therefore, I assume that FDA will keep it as it.

I think, this is an example of some deficiency in CDISC standards. It should be a special CT term(s) for Outcome to cover a case of changing Severity/Toxicity Grade of Adverse Event over time. Or some other solutions?

Kind Regards,

Sergiy

  

j Jozef
on May 5, 2020

IMO the wording "deficiency" is wrong here. It suggests that CDISC, and especially the CDASH user guide is wrong.
A better way to express this is that there is a discrepany or disagreement between how CDISC handles this and how FDA handles this.

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