How to Prepare an ICSR for ESG and EudraVigilance Submission
Preparing an ICSR for authority submission is a sequence of controlled decisions: confirm that the case is valid, structure the source data, code adverse events, assess seriousness and causality, resolve quality issues, and prepare the case for the target electronic reporting workflow. ESG and EudraVigilance processes have different operational contexts, but both reward clean structured data and early validation.
1. Confirm the report can become a valid case
Before a team thinks about gateway delivery, it should confirm that the report contains the information needed for case processing under the applicable procedure. This usually means verifying patient identifiability, reporter identifiability, suspected product information, and at least one suspected adverse event or reaction.
If information is missing, the workflow should document the gap and trigger follow-up when appropriate. Early triage prevents invalid or incomplete reports from moving through a submission pipeline as if they were ready.
2. Structure the narrative into reviewable case data
The source narrative should be transformed into fields that reviewers can inspect: patient demographics, event descriptions, event dates, seriousness criteria, suspect and concomitant products, dose information, laboratory data, medical history, outcomes, and narrative summary.
The VigiHelp AI engine helps accelerate this step by extracting structured information from verbatim text and preserving the link to the source wording. That link matters because reviewers need to see why a field was populated and where uncertainty remains.
3. Code adverse events and check medical consistency
MedDRA coding should be completed or reviewed before the case is considered submission-ready. Coding decisions can affect seriousness review, aggregate retrieval, signal detection, and authority expectations.
A submission workflow should check for event dates before exposure dates, outcomes that conflict with seriousness criteria, missing product-event relationships, duplicated reactions, and narrative statements that are not reflected in structured fields.
4. Prepare E2B(R3) and gateway-specific requirements
For E2B(R3) exchange, case data must be represented in the expected data elements and message structure. Regional and gateway-specific rules may add additional validations, sender configuration, acknowledgements, and testing expectations.
Teams using the FDA Electronic Submissions Gateway, EudraVigilance, or partner gateways should maintain documented procedures for validation, acknowledgements, resubmission handling, and follow-up case management.
Official references
These official sources informed the regulatory and terminology context of this guide. Teams should always confirm current requirements against their own procedures and target authorities.
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Use representative cases to test adverse event extraction, MedDRA coding review, causality support, existing case quality control, and preparation for E2B(R3), CIOMS, ESG, or EudraVigilance-related workflows.
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