🧠 Steps in ICSR (Individual Case Safety Report) – A Complete Journey of Ensuring Patient Safety

 In Pharmacovigilance, every Individual Case Safety Report (ICSR) tells an important story. It reflects how a medicine interacts with a patient in real life. ICSRs help regulatory authorities and drug safety teams identify, analyze, and prevent adverse drug reactions, ensuring safer healthcare outcomes.

Below is the complete life cycle of an ICSR, from the moment an adverse event is reported to its regulatory submission.

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🧾 1. Case Intake / Receipt

The ICSR process starts when a potential Adverse Event (AE) is reported.

Reports may come from:

• Healthcare professionals

• Patients or caregivers

• Literature articles

• Clinical trials

• Regulatory agencies

To consider the report valid, it must meet four essential criteria:

• Identifiable patient

• Identifiable reporter

• A suspect drug/procedure

• A reported adverse event

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💻 2. Data Entry

All information collected is entered into a Safety Database (e.g., Argus, ARISg, Veeva).
This includes:

• Patient details

• Drug name, dose, route, frequency

• Description of the adverse event

• Medical history, lab results, and timelines

Accuracy is crucial, as incorrect data can affect case assessment.

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⚙️ 3. Case Processing

This step ensures the case is scientifically and medically evaluated.

Key activities include:

• Coding medical terms using MedDRA

• Determining seriousness and expectedness

• Performing causality assessment

• Writing a clear, chronological medical narrative

This ensures the case is ready for review and compliance.

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✅ 4. Quality Review

A trained quality reviewer checks the case for:

• Missing or inconsistent information

• Correct MedDRA coding

• Accurate medical assessment

• Regulatory compliance adherence

This step ensures the report meets global quality standards.

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📤 5. Regulatory Submission

The finalized ICSR is submitted electronically to regulatory bodies such as:

• FDA

• EMA

• MHRA

• DCGI

• Local Health Authorities (based on region)

Submission timelines:

Case Type	Submission Time
Serious & Unexpected	Within 15 days
Non-serious	Within 90 days

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💡 6. Follow-Up (If Required)

If any information is incomplete, additional Follow-Up is requested from:

• Physicians

• Patients

• Study sites

• Medical facilities

Follow-up ensures the accuracy and completeness of the case.

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✨ Why This Process Matters

Each step in the ICSR workflow reflects the core purpose of Pharmacovigilance:

• Protecting patient health

• Ensuring safe medicine use

• Strengthening public trust in healthcare

ICSRs are not just reports — they are a commitment to patient safety.