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E2B(R3) case preparation that integrates with the safety database
ICH E2B(R3) is the electronic shape of an individual case safety report. AE Connect integrates the reviewed case with any safety database. Oracle Argus, ArisGlobal LifeSphere, and Veeva Vault Safety remain the system of record for that file.
What "E2B(R3) output" means here
The draft is organized around the concepts an E2B(R3) case needs from the source: seriousness, a MedDRA suggestion, causality, expectedness, a timeline, and a narrative. A reviewer accepts or overrides each field. AE Connect integrates that case with any safety database, including Oracle Argus, ArisGlobal LifeSphere, and Veeva Vault Safety. Those products remain the system of record.
What to read before a submission project
The E2B(R3) checklist is a readiness list for sponsors. The ICSR submission guide separates the message standard from the product. The deadline guide is about the FDA electronic-submission expectation, which is a regulatory fact, not a feature of this workspace.
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Questions
Where does the E2B(R3) file live?
AE Connect integrates the case with the safety database. That database remains the system of record for the E2B(R3) file.
How does the safety database get the case?
AE Connect integrates the reviewed case with the safety database. Oracle Argus, ArisGlobal LifeSphere, and Veeva Vault Safety remain the system of record.
Is the checklist the same as submission?
No. The checklist is a document. Submission stays outside AE Connect.