How to Process an Individual Case Safety Report
From first awareness of an adverse event to a submitted, coded, follow-up-tracked case.
What a how-to is not
A how-to is SPEQ’s practitioner method, not a procedure. It does not replace your own SOP, it is not a validated approach, and the judgement calls in it belong to your quality unit.
An Individual Case Safety Report (ICSR) is the atomic unit of pharmacovigilance: one patient, one or more suspected adverse reactions, one reporting obligation with a clock attached. The hard part is not the form — it is deciding the day zero from which the clock runs, and defending that decision later. Most inspection findings on case processing are about timing and completeness, not medical judgement.
- 1
Fix day zero and record how you know it
The reporting clock starts the day any member of your organisation, or anyone acting on its behalf, first becomes aware of a case meeting the minimum criteria. Record the date and the route of receipt at intake. A day zero reconstructed months later is the single most common cause of a late-submission finding.
- 2
Confirm the four minimum criteria
A valid case needs an identifiable patient, an identifiable reporter, a suspect product, and a suspected adverse reaction. Missing any one of them makes the report invalid rather than merely incomplete — but it does not end your obligation to seek the missing element.
- 3
Assess seriousness, expectedness, and causality
Seriousness is a regulatory definition, not a clinical opinion: death, life-threatening, hospitalisation or its prolongation, persistent or significant disability, congenital anomaly, or another medically important condition. Expectedness is judged against the reference safety information. These two determine which clock applies: in the EU a serious valid case is submitted within 15 calendar days and a non-serious EEA case within 90.
- 4
Code the case to the controlled vocabulary
Code reported terms consistently to the applicable medical dictionary and the product to the relevant substance and product dictionaries. Inconsistent coding is invisible in one case and destroys signal detection across thousands — the same reaction split across three terms will not cross a disproportionality threshold.
- 5
Seek follow-up before the clock expires
Structure the follow-up request around what would change the assessment: outcome, dechallenge and rechallenge, concomitant medication, medical history, dose and dates. Document each attempt. A case submitted with a documented unsuccessful follow-up attempt is defensible; one submitted with no attempt is not.
- 6
Submit in the required electronic format
Transmit to each authority in the format and to the gateway it specifies, and reconcile the acknowledgement. An unacknowledged transmission is not a submission, and the acknowledgement is the evidence you will be asked for.
- 7
Close the loop and archive the case
Retain the source document, the coded case, every follow-up attempt, and the transmission acknowledgement together. The reconstruction an inspector asks for is the whole chain from receipt to acknowledgement, not the final version of the record.
- !Day zero taken as the date the safety department received the case rather than the date anyone in the organisation first became aware of it.
- !Treating an invalid case as a closed case — the obligation to seek the missing minimum criterion continues.
- !Free-text reaction terms coded inconsistently, so the same reaction never aggregates into a detectable signal.
- !Submission counted as complete without reconciling the acknowledgement from the receiving gateway.
How to Process an Individual Case Safety Report: frequently asked questions
Common questions on process an individual case safety report.
When exactly does the reporting clock start?
On the day any person in your organisation, or any third party acting for it, first becomes aware of information meeting the four minimum criteria. It is organisation-wide awareness, not safety-department awareness — which is why intake from commercial, medical information and quality functions has to be defined and evidenced.
What makes a case valid rather than merely incomplete?
Validity requires an identifiable patient, an identifiable reporter, a suspect product, and a suspected adverse reaction. Missing one makes the case invalid, so it does not trigger the expedited clock — but it does not extinguish the duty to pursue the missing element and revalidate the case if you obtain it.
Does an adverse event found in the literature need processing?
Yes, where it concerns your product and meets the minimum criteria. Systematic literature review is a recognised source of post-approval safety information, and awareness on the day the relevant literature is screened starts the clock the same way a spontaneous report does.
Why does coding consistency matter so much?
Because signal detection is statistical. A reaction described three ways and coded three ways is three small counts instead of one meaningful one, and it may never cross the threshold that would prompt a review. Coding discipline is the difference between a safety database and a filing cabinet.