An Individual Case Safety Report (ICSR) is a report of an adverse event or suspected adverse reaction to a medicinal product that has occurred in a patient or study subject. Reporting of ICSRs is a critical component of pharmacovigilance, as it helps to identify and assess potential risks associated with the use of a medicinal product. The process for reporting an ICSR typically involves the following steps: Identification of an adverse event or suspected adverse reaction: This may occur through a variety of channels, including spontaneous reports from healthcare professionals or patients, reports from clinical trials or other studies, or signals detected through pharmacovigilance activities. Collection of information: Once an adverse event or suspected adverse reaction has been identified, information about the event must be collected, including the patient's demographic information, medical history, and details about the adverse event or reaction. Assessment of causality: The information collected about the adverse event or reaction must be assessed to determine whether there is a causal relationship between the medicinal product and the event. Completion of the ICSR: Once causality has been established, an ICSR must be completed, typically using a standardized form or electronic system. The ICSR should include all relevant information about the patient, the medicinal product, and the adverse event or reaction. Submission of the ICSR: The completed ICSR must be submitted to the appropriate regulatory authority, typically through a designated reporting system. It is important to report ICSRs in a timely and accurate manner, as this helps to ensure that potential risks associated with the use of medicinal products are identified and addressed promptly. Failure to report ICSRs can result in serious consequences, including harm to patients, regulatory action against pharmaceutical companies, and damage to public confidence in the healthcare system.

1. Welcome
INDIVIDUAL CASE SAFETY
REPORT (ICSRs)
Kusum Bang
M.Pharmacy
025/022023
03/03/2023
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2. Index
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Introduction
Importance of ICSR
What is included in an ICSR?
Work flow of ICSR
How are ICSRs collected?
Conclusion
Type of ICSR reports

3. Introduction
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● An ICSR is a document that contains information about a single patient who has experienced an adverse event or
suspected adverse reaction (ADR) after exposure to a drug or other medicinal product.
● ICSRs are typically submitted to regulatory authorities, such as the FDA in the United States, or the EMA in
Europe.
● These reports are used to monitor the safety of medicinal products and to identify potential safety concerns.
● Pharmacovigilance professionals review the reports and assess the causality of the adverse event, determine the
severity of the event, and decide on any necessary regulatory action.
The four elements for valid assessment of an ICSR are:
1. An identifiable patient,
2. An identifiable reporter,
3. A suspect drug and
4. An adverse event.

4. Importance of ICSR:
To provide critical information on the safety profile of drugs and medical products.
In post-marketing surveillance, it helps to ensure that any safety concerns that may arise after approval are identified and
addressed in a timely manner.
To improve patient safety by providing valuable information on the risks associated with particular drugs or medical products.
Uses of ICSR:
Signal detection: Signals can indicate the need for further investigation or regulatory action.
Risk assessment: It involves evaluating the severity, frequency, and potential outcomes of a particular adverse event or
suspected adverse reaction based on the available evidence.
Causality assessment: It involves evaluating the temporal relationship between the exposure to the drug and the onset of
the adverse event.
Benefit-risk assessment: It involves evaluating the potential benefits of the drug in terms of efficacy and patient outcomes,
compared to the potential risks associated with the drug based on the available evidence.
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5. What is included in an ICSR?
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1. Patient information: Name, age, gender, weight, height, medical history, and
other relevant demographic information.
2. Medication information: Name of the drug, dosage, route of administration,
frequency of use, indication, and duration of treatment.
3. Adverse event information: Description of the adverse event, including the
date of onset, severity, duration, and outcome.
4. Causality assessment: A judgment on whether the suspected drug caused the
adverse event, based on the available evidence.
5. Other relevant information: This may include laboratory test results, imaging
studies, or information about concomitant medication use.

6. How are ICSRs Collected?
1. Spontaneous Reporting: Healthcare professionals, patients, and consumers can voluntarily report adverse
events or suspected adverse reactions to regulatory authorities or pharmaceutical companies. The reports are then
reviewed and evaluated by pharmacovigilance professionals.
2. Active Surveillance: Active surveillance involves proactively monitoring patients who are using a specific
medicinal product to identify any adverse events or suspected adverse reactions. This information is used in clinical
trials or post-marketing surveillance studies.
3. Electronic Health Records (EHRs): Electronic health records can be used to identify potential adverse events
or suspected adverse reactions. EHRs can also be used to facilitate the reporting of ICSRs.
4. Literature Monitoring: Medical literature, including scientific publications and case reports, can be reviewed to
identify potential adverse events or suspected adverse reactions.
5. Social Media Monitoring: Used to identify potential adverse events or suspected adverse reactions particularly
useful for identifying adverse events that may not have been previously reported.
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7. Work flow of ICSR
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8. Types of ICSR Reports
Based on the sources and type of data collection, ICSRs are classified into two categories:
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Types of ICSR Reports
Solicited ICSRs Non Solicited ICSRs
● Interventional Clinical trials/ studies
● Non interventional clinical trials/ studies
● Non-interventional Programmes
● Patient Registries
● Patient support and market research
programmes
● Investigator initiated clinical trials,
Compassionate use programmes
● Literature, abstracts/ articles
● Legal cases reported by lawyers on behalf of
customers (client)
● Health authority case reports
● Spontaneous reports from health care
professional and directly from consumers.
● Social media reports - Any ICSR information
posted on social media websites like Facebook,
Twitter etc
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9. Conclusion:
• ICSRs are important tools in pharmacovigilance practice,
they provide valuable information on the safety of
medicinal products, and help to identify potential safety
concerns.
• Effective pharmacovigilance relies on the timely
reporting and analysis of ICSRs, and continuous
monitoring of the safety profile of medicinal products.
• By collecting and analyzing ICSRs, regulatory authorities,
healthcare providers, and manufacturers can identify
potential safety concerns and take appropriate actions to
mitigate risks.
• ICSR information can be used to develop better
treatment protocols, provide more accurate patient
counseling, and improve patient outcomes.
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10. References:
1. World Health Organization. The Importance of Pharmacovigilance: Safety Monitoring of Medicinal Products.
https://www.who.int/medicines/areas/quality_safety/safety_efficacy/importance/en
2. European Medicines Agency. What is a Suspected Adverse Reaction?. https://www.ema.europa.eu/en/human-
regulatory/research-development/pharmacovigilance/what-suspected-adverse-reaction
3. U.S. Food and Drug Administration. Individual Case Safety Reports (ICSRs). https://www.fda.gov/vaccines-
blood-biologics/safety-availability-biologics/individual-case-safety-reports-icsr
4. World Health Organization. Pharmacovigilance.
https://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmacovigilance/en/
5. European Medicines Agency. Importance of Pharmacovigilance. https://www.ema.europa.eu/en/human-
regulatory/overview/pharmacovigilance/importance-pharmacovigilance
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11. Thank You!
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