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AE and SAE intake form

An adverse event is an untoward medical occurrence. A serious adverse event meets a seriousness criterion, such as death, a life-threatening event, hospitalization, or disability. The intake form is where that distinction gets a first structured pass. It is not the submission.

What the form captures

Reporter, patient, product, event, and the seriousness flags the narrative supports. The AI draft proposes seriousness and a reason. A qualified person accepts or overrides it. The same screen covers the MedDRA suggestion, causality, expectedness, and timeline, so the AE or SAE is not still a free-text email when it reaches the safety database.

What this form is not

It is not a MedWatch form and not a replacement for Oracle Argus, ArisGlobal LifeSphere, or Veeva Vault Safety. AE Connect integrates with any safety database. Those products remain the system of record. The longer distinction between an AE and an SAE is in the adverse event reporting guide.

Keep reading

• Adverse event reporting: AE and SAE
• PV case intake
• SUSAR triage