What Is an Individual Case Safety Report (ICSR)?
A Key Component of Pharmacovigilance
Pharmacovigilance plays a vital role in overseeing the safety of medicinal products during the lifecycle of the products. The Individual Case Safety Report (ICSR) is considered to be one of the most significant tools that are employed to monitor and analyze adverse events. The ICSRs allow the regulatory bodies and pharmaceutical firms to recognize the possible safety hazards and take the necessary measures in time to safeguard patient health.
A specific case safety report (ICSR) refers to a report that contains the details of an individual patient with a suspected adverse event that occurs because of the use of a medicinal product. ICSRs can be either of healthcare professionals, patients, clinical trials, scientific literature or post-marketing surveillance.
All the ICSRs have organized contents enabling regulators to determine causality, severity, and foreseeability of the covered accident.
When Are ICSRs Required?
ICSRs are required to be provided to the regulatory bodies in instances when:- There is a high probability of major adverse events.
- The negative response is a surprise.
- This happens either in clinical trials or post-marketing.
Different jurisdictions have different submission schedules, e.g. 15 calendar days in most regulatory systems, including the EU and FDA systems.
Key Components of an ICSR
Patient Information Simple demographic information, including age, gender, and medical history. Adverse Event Details- Explanation of the reaction, severity, outcome, and the time of onset.
- The suspected product information is determined by the product data found on the design and packaging.
- Name of drug, dose, dates of treatment, and indication.
How Masuu Global Can Help
Masuu Global provides end-to-end pharmacovigilance services which covers processing of ICSR cases, medical review, quality control, and worldwide regulatory filing, which guarantees complete compliance and patient safety.