PHARMACEUTICAL ADVERSE EVENT REPORTING CHECKLIST

Created by ChecklistGuro (https://checklistguro.com)


--- EVENT IDENTIFICATION & INITIAL ASSESSMENT ---
[ ] Date of Event Occurrence
[ ] Time of Event Occurrence
[ ] Brief Summary of the Event
[ ] Initial Severity Assessment (Mild, Moderate, Severe, Life-Threatening)
[ ] Patient Age (years)
[ ] Reporting Source (Patient, Healthcare Professional, Caregiver, Other)

--- PATIENT INFORMATION VERIFICATION ---
[ ] Patient Full Name
[ ] Date of Birth (YYYY-MM-DD)
[ ] Patient Medical Record Number
[ ] Gender (Male, Female, Other, Prefer not to say)
[ ] Relevant Medical History (Brief Summary)
[ ] Patient Contact Method Preference (Phone, Email, Mail)

--- PRODUCT INFORMATION CONFIRMATION ---
[ ] Drug Name
[ ] Lot Number
[ ] Expiration Date (YYMMDD)
[ ] Quantity Administered
[ ] Dosage Form (Tablet, Capsule, Solution, Injection, Other)
[ ] Product Packaging Photo (if available)

--- EVENT DESCRIPTION AND TIMELINE ---
[ ] Detailed Description of Adverse Event
[ ] Date of Event Onset
[ ] Time of Event Onset
[ ] Date of Event Resolution (if applicable)
[ ] Time of Event Resolution (if applicable)
[ ] Duration of Event (in hours/minutes)
[ ] Sequence of Events Leading Up to the Adverse Reaction
[ ] Severity of Event (e.g., Mild, Moderate, Severe) (Mild, Moderate, Severe)

--- MEDICAL INTERVENTION & OUTCOME ---
[ ] Describe the medical interventions performed (e.g., medications, procedures).
[ ] Dosage of medication administered (if applicable).
[ ] Date of intervention.
[ ] Time of intervention.
[ ] Describe the patient's immediate response to the intervention.
[ ] Overall Outcome of Intervention (Improved, Stable, Worsened, No Change)
[ ] Describe any long-term effects or sequelae observed.

--- PHYSICIAN/HEALTHCARE PROVIDER CONFIRMATION ---
[ ] Physician/Healthcare Provider Signature
[ ] Date of Confirmation
[ ] Physician/Healthcare Provider Name
[ ] Physician/Healthcare Provider Credentials
[ ] Summary of Physician Assessment (e.g., Causality Assessment, Severity)
[ ] Causality Assessment (e.g., Definite, Probable, Possible, Unlikely, Not Related) (Definite, Probable, Possible, Unlikely, Not Related)
[ ] Severity Score (if applicable, per internal scoring system)

--- REGULATORY REPORTING REQUIREMENTS ---
[ ] Reporting Jurisdiction (United States (FDA), European Union (EMA), Canada (Health Canada), Other (Specify in Long Text))
[ ] Reporting Form Type (3500A, 15-Day Report, Annual Report, Other (Specify in Long Text))
[ ] Specific Regulatory Guidelines Applied
[ ] Reporting Deadline (Days)
[ ] Submission Date
[ ] Supporting Documentation (Regulatory)

--- INTERNAL REPORTING AND DOCUMENTATION ---
[ ] Case/Incident ID
[ ] Date of Internal Report
[ ] Summary of Adverse Event (for internal records)
[ ] Severity Assessment (Internal) (Minor, Moderate, Severe, Life-Threatening)
[ ] Affected Departments (Manufacturing, Quality Assurance, Pharmacovigilance, Medical Affairs)
[ ] Supporting Internal Documents (e.g., lab reports)
[ ] Internal Notes/Comments

--- REVIEW AND APPROVAL ---
[ ] Reviewer Signature
[ ] Review Date
[ ] Review Outcome (Approved, Requires Revision, Rejected)
[ ] Reviewer Comments (if applicable)
[ ] Revision Count (if applicable)

--- SUBMISSION AND TRACKING ---
[ ] Submission Date
[ ] Submission Time
[ ] Submission Method (Online Portal, Email, Mail)
[ ] Tracking Number (if applicable)
[ ] Confirmation Code (if applicable)
[ ] Notes on Submission (e.g., communication with agency)
[ ] Submission Status (Submitted, Received (Agency), Under Review, Accepted, Rejected)

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