SOP: Individual Case Safety Report (ICSR) Intake, Triage, and Processing

This is a ready-to-use SOP for the intake, triage, and processing of individual case safety reports (ICSRs), the anchor procedure a pharmacovigilance system runs on. Replace every <<FILL: ...>> placeholder, route it through document control, and confirm every cited regulation against the current source before you rely on it. This content is educational reference, not legal or regulatory advice.

Document control header

1. Purpose

This procedure defines how <<FILL: COMPANY NAME>> receives, validates, triages, codes, medically reviews, and submits individual case safety reports so that every case is captured, attributable, and reported within its regulatory timeline, regardless of the channel it arrived through.

2. Scope

This procedure applies to all sources of potential adverse event information for <<FILL: COMPANY NAME>> marketed and investigational products: spontaneous reports, solicited reports (patient support programs, market research, registries), literature, digital and social media channels the company monitors, and reports received from license partners, distributors, and contract service providers. It covers case receipt through submission and follow-up. It does not cover signal detection and management, which is governed by <<FILL: SOP-ID for signal management>>, or periodic aggregate reporting, governed by <<FILL: SOP-ID for PBRER/PSUR/PADER>>.

3. Responsibilities

4. Definitions

• ICSR (Individual Case Safety Report): the structured record of a single adverse event experienced by a single patient, attributed at least as suspected to a medicinal product.
• Day zero: the date any employee or contractual partner of the company with a reporting duty first becomes aware of information meeting the minimum four elements of a valid case, regardless of which internal function received it first.
• Valid case: a case meeting all four minimum elements: an identifiable patient, an identifiable reporter, a suspect product, and an adverse event or outcome.
• Verbatim: the reporter’s original words describing the event, retained unaltered alongside the coded MedDRA term.
• Serious: an event meeting one or more of the defined outcome criteria in section 5.3, distinct from severity (intensity).

5. Procedure

5.1 Receive and log

1. Log every potential case at the point of receipt, from any channel: phone, email, fax, portal, literature screen, social media monitoring, partner transmission, market research, patient support program, or spoken to any employee.
2. Capture the date and, where relevant, time of receipt in the safety database automatically, not by manual entry, so day zero cannot be altered after the fact.
3. Assign a unique case identifier at receipt.

5.2 Apply the four-element validity test

1. Confirm an identifiable patient (age, sex, initials, or a case identifier is sufficient; a name is not required).
2. Confirm an identifiable reporter who could, in principle, be recontacted.
3. Confirm a suspect product, named specifically.
4. Confirm an adverse event, sign, symptom, or abnormal finding described as adverse.
5. If any element is missing, the case is not yet valid. Initiate and document a follow-up attempt within <<FILL: number>> business days. Do not discard an incomplete report without a documented follow-up attempt.

5.3 Assess seriousness

1. Determine whether the event meets any of: results in death; is life-threatening at the time of the event; requires or prolongs inpatient hospitalization; causes persistent or significant disability; is a congenital anomaly; or is an important medical event by medical judgment.
2. Record the seriousness determination and its basis. Do not substitute an assessment of severity (mild, moderate, severe) for the seriousness determination.
3. Route serious and unexpected cases to the expedited reporting track (section 5.6); route all other valid cases to the periodic aggregation dataset.

5.4 Code and preserve the verbatim

1. Enter the reporter’s original description verbatim in a dedicated, protected field.
2. Code the event to the current MedDRA version in a separate field, at the most specific Lowest Level Term supported by the information available.
3. Never overwrite the verbatim when recoding to a new MedDRA version; add the new code as a new dated entry.
4. Identify the product using the company’s current product and substance identification standard (including ISO IDMP references where applicable).

5.5 Medical review

1. A qualified safety physician reviews causality, expectedness (against the current approved labeling or reference safety information), and the completeness of the case narrative.
2. Record the reviewer’s identity, the date, and the rationale for the causality and expectedness determination.
3. Version, do not overwrite, any change the medical reviewer makes to a prior entry; retain both the original and the revised value with the reason for the change.

5.6 Determine reporting obligation and submit

1. Serious and unexpected: route to expedited submission within 15 calendar days of day zero (or 7 calendar days for fatal or life-threatening investigational SUSARs, per <<FILL: applicable IND/CTA safety reporting SOP>>).
2. Non-serious or serious-but-expected: route to the periodic aggregation dataset; no individual expedited submission is required.
3. Transmit in the applicable E2B format to the required gateway(s) (for example FAERS, EudraVigilance, or a national authority) per the product’s submission matrix.
4. Retain the transmission acknowledgment (ACK). A negative or missing ACK is a submission failure, not a completed report, and must be corrected and retransmitted.

5.7 Follow-up

1. Chase missing information needed to complete validity, seriousness, or causality assessment, on a documented schedule.
2. Create a new version of the case for each follow-up received; do not overwrite prior versions.
3. Re-evaluate the reporting clock if follow-up information changes the seriousness or expectedness determination.

6. Acceptance criteria

• Every potential case, from every channel in scope, is logged at receipt with a system-captured date.
• Every valid case has a documented four-element assessment, seriousness determination, and expectedness determination.
• The verbatim is preserved unaltered and separately from the coded term for every case.
• Every serious and unexpected case is submitted within 15 calendar days of day zero, or the delay is documented as a deviation.
• Every submission has a retained acknowledgment; negative or missing acknowledgments are corrected.

7. References

21 CFR 314.80 and 21 CFR 600.80 (postmarketing adverse experience reporting, US). 21 CFR 312.32 (IND safety reporting, US). EU GVP Module VI (collection, management, and submission of reports of suspected adverse reactions). ICH E2D(R1), Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports. ICH E2B(R3), Data Elements for Transmission of Individual Case Safety Reports.

Confirm the current version and clause numbers of each reference before issue.

8. Record generated: ICSR processing record

9. Revision history

10. Approvals

Filled specimen

A partial completed record for an example case. Illustrative only.

Day zero here is the nurse-line call date, not the date the case reached the central PV inbox two days later, because the nurse line staff are a contractual reporting channel. That two-day internal gap did not affect the reporting clock only because the case was non-serious; had it been serious, the clock would already have lost two of its 15 days before central PV ever saw it, which is exactly why the intake channel training in section 5.1 matters as much as the coding rules that follow it.

Common inspection findings this SOP prevents

• Day zero recorded as the date the central PV function received the case, rather than the date any company channel first became aware.
• A follow-up attempt for an incomplete case is not documented, so it looks like the case was simply dropped.
• The verbatim is overwritten during recoding, so the original reporter’s words cannot be reproduced.
• A submission has no retained acknowledgment, so a rejected or failed transmission goes unnoticed.
• Seriousness is assessed using severity language (“it was pretty bad”) instead of the defined outcome criteria.

How to adapt this SOP

1. Set your document number, owner, and effective date in the header.
2. List every actual intake channel your organization operates (support programs, vendors, partners, literature, social media) in section 2 and section 5.1, not a generic list.
3. Point the cross-references in sections 2 and 5.6 to your real signal-management, periodic-reporting, and IND/CTA safety-reporting procedures.
4. Insert your actual E2B gateway(s) and submission matrix in section 5.6.
5. Confirm every regulation in section 7 against the current published version before issue.