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Send email to the safety group when an AE is marked as Serious or Significant
Serious adverse events need to be reported to the FDA within a certain window of time from when the sponsor is made aware of them. The sponsor awareness date is calculated from the date the adverse event is marked as Serious. If there is a separate Safety Case form, that triggers the creation of a case in Argus. If the site forgets to add a Safety Case form, the email can be used to alert the safety group that a Safety Case form is needed.
lab
Item |
Description |
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When to use |
If you are using a separate AE and Safety Case form, you can optionally add a rule to send an email to your safety group or study team when the AE is marked Serious or Significant. |
Purpose |
Alert the safety group or study team that there is an SAE in the system before the site user creates the safety case form that triggers the SAE to be sent to Argus. |
Triggering controls |
Y or N codelists for the following:
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Action when rule is triggered |
Sends an email to the safety group or study team. You can customize the content of the email based on study team needs. |
Rule expression |
In the example below, the user has added AE event, subject number, site number, and the AE sequence number. evaluate on Form Submission
value = !this.AE001.Current().IsDeleted && !this.AE001.Current().sctAE001_01.AESER.Empty && this.AE001.Current().sctAE001_01.AESER.Value == this.AE001.Current().sctAE001_01.AESER.clNY_1.cliNY_4
when value is true send email on
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