ICSR (Individual Case Safety Report) is a critical component of pharmacovigilance, which involves the collection, processing, and reporting of adverse events associated with the use of drugs and other medical products. The collection of ICSRs involves the systematic and proactive collection of adverse event data from a variety of sources, including healthcare professionals, patients, and regulatory authorities. The process typically involves the use of standardized reporting forms, which capture information about the patient, the drug product, and the adverse event. In addition to spontaneous reporting, ICSRs may also be collected through clinical trials, post-authorization safety studies, and other surveillance programs. Once an ICSR is received, it is subjected to a process of validation and assessment to ensure that it is complete and of sufficient quality to be included in the pharmacovigilance database. This involves checking that the report contains all the required information and that it is consistent with known safety profiles of the drug product. After validation, the ICSR is coded according to standard medical dictionaries, such as MedDRA (Medical Dictionary for Regulatory Activities), which allows for consistent and accurate reporting of adverse events across different products and databases. The data is then entered into the pharmacovigilance database, where it is analyzed for potential safety signals or trends. Reporting of ICSRs is an essential component of pharmacovigilance, and regulatory authorities require that pharmaceutical companies report adverse events associated with their products in a timely and accurate manner. The process of reporting typically involves the submission of periodic safety update reports, as well as ad-hoc reports for significant safety events.

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Collection, Processing and Reporting of ICSR

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The collection, processing, and reporting of an individual case study report document involve several important steps.
These steps include
Identifying the case study subject: The first step in the process is to identify the individual or organization that will be the focus of the case study.
This could be a person, a company, a product, or a service
Collecting data: Once the case study subject has been identified, the next step is to collect data. This could include gathering information about
the individual's background, the company's history, the product's features, or the service's benefits. Data can be collected through various methods
such as interviews, surveys, and document reviews.
Analyzing the data: After collecting the data, it is essential to analyze it to identify key themes and patterns. This can involve using various tools
such as statistical analysis, content analysis, and discourse analysis.
Writing the report: The next step is to write the report. The report should include an executive summary, an introduction, a description of the case
study subject, a detailed analysis of the data, and a conclusion that summarizes the findings.
Reviewing the report: After writing the report, it is important to review it for accuracy and completeness. This can involve seeking feedback from
stakeholders and subject matter experts.
Sharing the report: Finally, the report should be shared with relevant stakeholders, such as executives, managers, and employees. This can be
done through various means such as presentations, emails, or reports.
Overall, the collection, processing, and reporting of an individual case study report document require careful planning, attention to detail, and a
thorough understanding of the case study subject. By following these steps, you can ensure that the report provides valuable insights and
recommendations that can help inform decision-making and improve organizational performance.

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4. • An Individual Case Study Report (ICSR) is a safety service document that includes information required for reporting the adverse events and
problems related to products and complaints filed by consumers with respect to any product. It is an important facet of adverse event
reporting which is a source of data in PV (Pharmacovigilance). The ICSR is most commonly associated with PV. To build a compliant ICSR,
there are four elements that must be mentioned
• A diagnosed patient
• A reporter
• A suspect drug
• An adverse event
• Adverse event reporting is a Regulatory requirement in most of countries for pharmaceutical companies. It also provides data to the
companies and drug Regulatory authorities that play a key role in assessing the risk-benefit profile of a given drug. The source of adverse
event reports may include reports from:
• Healthcare professionals or patients
• Patient support programs
• Clinical or post-marketing studies
• Literature sources Media including websites Or,
• reported to drug Regulatory authorities themselves
• The implementation of ICSR varies from drug to drug. The applicant must reach out to the Regulatory agency before submitting the reports to
clarify the content of ICSR. More details about the content and guidance document of ICSR is available on the websites of the agencies.
• An ICSR is considered to be valid for reporting to a regulatory authority
• if it has; at least one single identifiable patient
• One identifiable reporter One or more suspect adverse drug reaction One or more suspect identifiable product
• If one or more of these events are missing, the case is not a valid AE report or is said to be an invalid case.
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5. The following steps involves in ICSR Case Processing Workflow
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The following steps involves in ICSR Case Processing Workflow
1. Case receipt
2. Data Verification and Validity check and Validity Assessment
3. Triage
4. Duplicate search
5. Book-in and registration
6. Complete data entry
7. Quality review
8. Follow-up of reports
9. Medical review
Case Reporting, The information that needs to be reported;

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1. Case receipt
2. Data Verification and Validity check and
Validity Assessment
3. Triage
4. Duplicate search
5. Book-in and registration
6. Complete data entry
7. Quality review
8. Follow-up of reports
9. Medical review

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