This Blog Features:
- Data elements associated with valid ICSR criteria.
- Detailed breakdown of the four essential ICSR components.
- Key takeaways
Table of Contents
Introduction
Understanding the valid criteria for an Individual Case Safety Report (ICSR) is essential, yet many associates may be unaware of these key elements.
As a result, invalid cases are sometimes processed due to a lack of clear definitions, leading to unnecessary nullifications.
We have previously discussed the criteria for distinguishing a valid ICSR from an invalid one. In this blog, we will explore the main elements and sub-elements of each criterion in detail.
Validating an ICSR
As we know, a valid ICSR report must include at least four essential criteria. Building on this foundation, we will explore the key components within each criterion to ensure proper validation.
We recommend reviewing and incorporating as many of the following key data elements as possible:
An identifiable patient
Every case report must involve a patient. To consider a patient as identifiable, certain elements must be present in the source file to confirm their identity. The following details help establish patient involvement in the report, listed in order of importance based on data availability.
- Patient initials
- Any other relevant identifier such as patient number
- Sex
- Weight
- Height
- Ethnicity
- Relevant family history
- Age at time of reaction
- Age category (e.g. adolescent, adult or elderly) or date of birth)
- Date of birth
- The patient’s medical history including relevant past medicine history
- For reports about maternal/paternal or foetal exposure
- the gestation period at time of exposure
- information about the parent (e.g. their identity, age or date of birth, date of last menstrual period, weight, height, gender, relevant medical history and concurrent conditions, relevant past medicine history).
“A valid ICSR is built on four essential pillars—an identifiable patient, a suspected drug, a reliable reporter, and a documented adverse event. Ensuring accuracy in these elements transforms data into meaningful safety insights.”
Suspected Drug/Medicine
Just as the patient is a crucial component of the case, at least one drug must be present and administered to the patient, being potentially responsible for the adverse event. In our source case file, at least one belong to the medicine that should belong to our company’s product line (suspected medicines) are considered valid for processing.
- Name (INN and brand name)
- Strength (concentration)
- Dose, Frequency
- Dosage form and strength
- Route of administration
- Site of administration
- Indication for use
- Starting date and time
- Stopping date and time or duration of treatment
- Duration of use, date started, date stopped
- Batch number (especially for vaccines)
- Any changes to medicine administration (e.g. medicine withdrawn, dose reduced, dose increased, dose not changed)
- Any additional relevant information on the medicine
- f the reaction is suspected to be the result of an interaction with alcohol, food or another medicine, the names and active ingredients of the suspected interacting medicines or substances.
Suspected adverse event/reaction
Suspected adverse reaction/event at the time of after the suspected drug adminsitered.
- Description of the reaction
- The primary source’s description of the reaction, verbatim
- Expectedness of the reaction (in accordance with the approved product information)
- Seriousness of the reaction
- Date the reaction started, stopped
- Outcomes attributed to adverse reaction
- Relevant tests/laboratory data (if available)
- Why the report is considered serious
- A description of the signs and symptoms
- A specific diagnosis of the reaction
- When the reaction ceased, or its duration
- Dechallenge and rechallenge information
- Results and laboratory data from relevant testsLocation where the reaction occurred (e.g. hospital, outpatient clinic, home or nursing home)
- If relevant, date of death
- Whether an autopsy was performed and, if so, any relevant autopsy or post-mortem findings, including coroner’s report
- Cause of death for a fatal outcome
- Relatedness of medicine to reaction(s)/event(s)
- Assessment of reaction—source of assessment (e.g. initial reporter, investigator, regulatory agency, company), method of assessment (e.g., global introspection, algorithm, Bayesian calculation) and result
- Sponsor’s comments (e.g. diagnosis/syndrome and/or classification of reaction/event)
- Whether the case was medically confirmed, including medical documentations (e.g. laboratory or other test data) provided by either a consumer confirming the adverse reaction occurred, or an identifiable healthcare professional)
An identifiable reporter
A reporter can be a consumer, healthcare professional (HCP), or another relevant individual. Some cases may involve multiple reporters who are aware of the incident.
- Name/ initials
- Mailing Address /email address
- Contact details (telephone number)
- Qualification (specialty e.g. physician, pharmacist, other healthcare professional; lawyer, consumer or other non-healthcare professional)
- Reporter type (e.g. consumer, healthcare professional etc.)
Key Takeaways
The four criteria do not necessarily need to be directly reported.
The patient’s name should always remain anonymous if the event is fully reported.
Ensure all reporter information is accurately captured as provided in the source.
Any available information that aligns with the criteria should be considered.
How can we assist you in ICSR management?
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We specialize in ICSR management to enhance your workflow. Don’t just think and wait—take action now!
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Conclusion
This article has provided a deeper understanding of the essential elements required for ICSR validation, including the latest E2B(R3) necessary components for clear and accurate reporting.
If you notice any missing elements or have suggestions for improvement, feel free to bring them to our attention. Share this content with your colleagues and friends, and support our blog by spreading the word!
Acronym
- INN: International Non-proprietary Name
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