ICSR (individual case safety report)

An Individual Case Safety Report (ICSR) is a document that contains information about a single adverse event or suspected adverse reaction to a medicinal product. It is a critical component of pharmacovigilance, which is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.

ICSRs are typically generated by healthcare professionals, patients, or clinical trial investigators, and they include a detailed description of the adverse event, patient demographics, medical history, and details about the medicinal product(s) involved. The report also contains an assessment of the causal relationship between the adverse event and the medicinal product(s), as well as any medical interventions or outcomes that occurred.

ICSRs are essential for identifying potential safety issues with medicinal products and for assessing the risk-benefit profile of a product. They also help to ensure that regulatory authorities, such as the FDA or EMA, are notified of any safety concerns associated with a medicinal product.

ICSRs must comply with international reporting requirements, which specify the information that must be included in the report, as well as the timeframe for submission. The information in an ICSR must be accurate and complete to enable effective analysis and evaluation of the safety data.

ICSRs are a crucial aspect of pharmacovigilance and the regulatory process, as they provide valuable information for the ongoing evaluation of the safety of medicinal products. The prompt reporting of ICSRs is essential for ensuring the timely detection and assessment of any safety concerns associated with the use of medicinal products.

1. Welcome INDIVIDUAL CASE SAFETY REPORT Student’s Name – Prathamesh Bhaskar Golapkar Student’s Qualification - MSc Student ID – CSRPL_STD_IND_HYD_ONL/CLS_027/022023 3/6/2023 www.clinosol.com | follow us on social media @clinosolresearch

2. Index What is ICSR ? A Valid ICSR contains Steps involved in ICSR ISCR Collections Case processing Data Entry Points to remember 3/6/2023 www.clinosol.com | follow us on social media @clinosolresearch 2

3. 3/6/2023 www.clinosol.com | follow us on social media @clinosolresearch 3 ICSR is Format/Content Related to Medical product at specific point of time. What is ICSR…?? For reporting ADR occur in single patient

4. A Valid ICSR contain atleast : 3/6/2023 www.clinosol.com | follow us on social media @clinosolresearch 4 1 Identifiable Reporter 1 Identifiable Patient 1 Suspected A/E 1 Suspected Medicinal Product

5. Steps involved in ICSR 3/6/2023 www.clinosol.com | follow us on social media @clinosolresearch 5 ICSR Collection Regulatory Submission Medical Review Quality Review Data Entry and Case Processing Triage

6. ICSR Collections : 3/6/2023 www.clinosol.com | follow us on social media @clinosolresearch 6

7. Case Processing : 3/6/2023 www.clinosol.com | follow us on social media @clinosolresearch 7 Check for duplicate and Valid ICSR No duplicate, Case forwarded to Data entry team. If Duplicate, Case deleted. After receipt of SAE forms Drug Safety Associate

8. Data Entry : 3/6/2023 www.clinosol.com | follow us on social media @clinosolresearch Source of Data Patient details Details related to Suspected ADR Reporter details Suspected Medicinal Product Finally, Narrative writing

9. 3/6/2023 www.clinosol.com | follow us on social media @clinosolresearch 9 Quality Review team checks for any Data Entry error If Issue found, form resend to Data Entry team for corrections. If no issue found, Case forwarded to Medical Review team.

10. 3/6/2023 www.clinosol.com | follow us on social media @clinosolresearch 10 Medical review Physician Team ensures that all Medical aspects were address properly Finally, Regulatory submission.

11. 3/6/2023 www.clinosol.com | follow us on social media @clinosolresearch 11 Points to Remember : Non-Medically Confirmed Case If SAE is reported by non-health care professional like Patient. Medically Confirmed Case If SAE is reported by non-health care professional like Doctor, Pharmacist, Nurse.

12. Thank You! www.clinosol.com (India | Canada) 9121151622/623/624 [email protected] 3/6/2023 www.clinosol.com | follow us on social media @clinosolresearch 12