icsr workflow & management_katalyst hls

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ICSR Workflow and

Management

Katalyst Healthcares & Life Sciences

2Agenda

1. Identify the minimum criteria for ICSR.2. Distinguish between serious and non-serious reports.3. Identify HCP reports.4. Determine medically confirmed reports5. Define non-ICSR.6. Describe the case processing and assessment

workflow process.7. List the roles and associated responsibilities of

persons involved in PV workflow.8. Explain the query process.


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What is an “Adverse Event” (AE)? An adverse event is any untoward medical occurrence

in a patient, clinical investigation subject or consumer administered a product or medical device.

The event need not necessarily have a causal relationship with the treatment or usage of the product or medical device.


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Adverse Reaction: WHO technical report:A response to a drug which is noxious and unintended and which occurs at doses normally used in humans for the prophylaxis, diagnosis or therapy of disease or for the modification of physiological function

Adverse Event Vs Adverse Reaction:Adverse event time relationship with drug is positive and causal relationship with drug is negative.


5What is the minimum criteriathat an Adverse Event report must contain?

Identifiable Patient: A specific individual or a known number of specific individuals is involved. At least one of the following characteristics must be available: Age, age group, gender, birth date, or patient ID number.Suspect Product: Clearly refers to or names a drug, biologic, medical device, over-the-counter (OTC) product, or blinded therapy unless the event occurs in a clinical trial during a non-treatment period.Adverse Event: A description of at least one event such as a sign, symptom, diagnosis or of a circumstance leading up to an increased risk of an event, for example, EIU, overdose, misuse.Identifiable Reporting Source: The reporter is clearly identified establishing that there was first-hand knowledge of the identifiable patient/subject/consumer.Katalyst Healthcares & Life

Sciences

6Non Valid cases:

For non-valid cases every attempt should be made to follow-up the case to obtain the minimum information that constitutes a valid ICSR. The same process and time frames mentioned above for spontaneous reports will be applied.

Non valid cases are still entered in to safety database.


7SERIOUSNESS CRITERIA

Death Life-threatening Results in inpatient or prolonged hospitalization Results in persistent or significant disability/incapacity Results in congenital anomaly/birth defect Important medical event (IME) – Medical and scientific judgment

determines that the event may jeopardize the patient and/or may require intervention to prevent one of the outcomes listed above (Examples: intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias, drug abuse)Katalyst Healthcares & Life

Sciences

8Exceptions to Hospitalization as SAEs

In the absence of a medical adverse event Admission for treatment of a pre-existing condition not associated

with the development of a new AE or with a worsening of a pre-existing condition

Social admission Administrative admission Protocol-specified admission during the study Optional admission not associated with a precipitating medical AE


9MedDRA Preferred-(Critical)-Terms


10CONFIRMATION OF CASE SERIOUSNESS

No changes are made to the seriousness classification of a case if:

The case is received as serious from an HCP. The case is received from a license partner or a

regulatory authority/registry A clinical trial case is reported as serious, for which

no event terms appear to meet seriousness criteria and no clarification can be obtained from the investigator in due time.

IME listKatalyst Healthcares & Life

Sciences

11Healthcare Professional (HCP) Reports

Physicians Dentists Pharmacists Nurses Coroners Employees of a physician or other HCP who contact Pfizer on behalf of the

physician Other health professionals specified by local regulations, e.g. Physician’s

Assistant in US, psychologist in Germany Literature reports from medical and scientific journals Clinical study reports (Exception: Reports in which a clinical study

patient/subject is reporting on himself/herself) Regulatory agency reports except where the reporter to the regulatory agency

is identified not to be an HCP (e.g. a consumer)Katalyst Healthcares & Life Sciences

12What is a medically confirmed report?

A report in which an HCP confirms the occurrence of one or more of the AEs reported and does not deny the relationship of the confirmed AEs to the comp any product.

Determination of whether an adverse event report is medically confirmed is necessary when:

The initial case was received from a non-HCP source The case did not originate from a clinical study Follow-up information is received from an HCP source


13Case processing and assessment workflow process


14Query Overview

Queries are captured on the ‘Activities’ tab as individual ‘Action Items’

Queries can be entered / revised during any step of case processing E.g. Data Entry, QC, Medical Review

The individual query is to be entered as an individual action item Do NOT enter multiple queries in one action item


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Thank You and

QuestionsKatalyst Healthcares & Life

Sciences

icsr workflow & management_katalyst hls

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