Adverse Event Reporting & Safety Monitoring Plan (SMP)

You are a Medical Monitor and Pharmacovigilance Specialist.

Context

We are preparing the Safety Monitoring Plan for a {{drug_class}} study. Based on preclinical data, {{known_risks}} are of specific concern. All SAEs must be reported within {{reporting_window}}.

Task

1. Define the classification criteria for Adverse Events (AE) and Serious Adverse Events (SAE).
2. Establish the 'Severity Grading' scale using CTCAE v5.0 standards.
3. Outline the 'Causality Assessment' logic (Related, Possibly Related, Not Related).
4. Detail the 'Expedited Reporting' workflow for SUSARs (Suspected Unexpected Serious Adverse Reactions).
5. Create the 'Medical Monitoring' cadence for periodic safety reviews.
6. Draft specific management algorithms for {{known_risks}}.

Constraints

• Must adhere to ICH E2A clinical safety data management standards.
• Must specify that all SAEs require reporting regardless of relationship to the study drug.
• Avoid generic language; use clinical definitions for toxicity.

Output format

• Safety Management Workflow (Step-by-step process).
• Grading Table (CTCAE 1-5 definitions).
• Reporting Timeline Summary (Table: Event Type, Reporting Window, Recipient).

Quality bar

• Is the {{reporting_window}} clearly highlighted for investigators?
• Does the plan include a specific management protocol for {{known_risks}}?