What is individual case study report?
An Individual Case Study Report (ICSR) is a safety service document which includes information required for reporting the adverse events and problems related to products and complaints filed by consumers with respect to any product.
What is IRD in pharmacovigilance?
Initial Receipt Date (IRD) The concept of Initial Receipt Date (IRD) is one of the most basic and preliminary learning for pharmacovigilance staff. This is usually well covered during all staff as well as cross functional training.
Who can report Icsr?
Adverse event reporting The individual case study report (ICSR) is an adverse event report for an individual patient and is the source of data in pharmacovigilance. The main focus of ICSRs are reports from healthcare providers and patients in member countries of the WHO Programme.
What are the types of Icsr?
Types of ICSR reports
- Interventional Clinical Trail/Studies.
- Non-Interventional Clinical Trial/Study.
- Non-Interventional Programmes.
- Patient Registries.
- Patient support & Market research programmes.
- Investigator Initiated clinical Trails, Compassionate use programmes etc.,
What is individual case safety report Icsr?
Description: The HL7 Individual Case Safety Report (ICSR) captures information needed to support reporting of adverse events, product problems and consumer complaints associated with the use of FDA regulated products.
What is aggregate report?
Aggregate Reports refers to those reports that focus not so much on individual cases, but rather on overview, assessment of the safety profile and benefit-risk-evaluation. They comprise e.g. or safety related parts of Clinical Study Reports.
What does Susar stand for?
An SAE that occurs during research with a medicinal product may be a SAR or a SUSAR. SAR is the abbreviation for Serious Adverse Reaction, and SUSAR for Suspected Unexpected Serious Adverse Reaction.
Is a Susar an Icsr?
Globally ICSR are reported under 3 categories : Clinical Death/Life threatening cases and SUSAR (Suspected Unexpected Serious Adverse Reaction) cases are reported within 7 calendar days to the NCA (national competent authorities)/HA (health authorities).