Pharmacovigilance in Clinical Trials

🧪 Pharmacovigilance in Clinical Trials

✅ What Is It?

Pharmacovigilance in clinical trials refers to the detection, assessment, reporting, and prevention of adverse events (AEs) or adverse drug reactions (ADRs) during the clinical development phase of a medicinal product.

It primarily focuses on ensuring volunteer/patient safety and fulfilling regulatory obligations before marketing authorization.

📌 Key Objectives

Protect the health and safety of clinical trial participants.
Detect unexpected or serious risks early.
Ensure accurate documentation and timely reporting of safety data.
Comply with GCP (ICH E6), ICH E2A, and regional regulations (e.g., EMA, FDA, CDSCO).

🔍 Main Activities in PV During Clinical Trials

Activity	Description
Adverse Event (AE) Collection	All AEs (serious and non-serious) are recorded, regardless of causality.
Serious Adverse Events (SAE) Reporting	Must be reported immediately to the sponsor and within 7/15 days to regulators depending on the case.
Suspected Unexpected Serious Adverse Reactions (SUSARs)	Reported in an expedited manner to authorities and ethics committees.
Causality Assessment	Sponsor and investigator assess the relationship of the AE to the investigational product.
Development Safety Update Report (DSUR)	Annual safety report summarizing all safety data during development.
Safety Data Reconciliation	Align clinical data (e.g., CRFs) with safety databases to ensure consistency.
Risk Management Planning	Identification and evaluation of potential risks for further monitoring in post-marketing phase.

🏛️ Regulatory Guidelines & Documents

Guideline	Focus
ICH E2A	Definitions and expedited reporting standards for clinical safety data.
ICH E2F (DSUR)	Annual development safety update reporting for ongoing trials.
ICH E6 (R2)	GCP – emphasizes investigator/sponsor responsibility in AE reporting.
FDA 21 CFR Part 312	US IND safety reporting requirements.
EU CTD / EU Clinical Trial Regulation (CTR)	Safety reporting obligations under EU law.

⚠️ Types of Safety Events in Clinical Trials

Term	Definition
AE	Any untoward medical occurrence in a participant, not necessarily causally related.
ADR	AE with at least a reasonable possibility of causal relationship with the drug.
SAE	AE that results in death, is life-threatening, requires hospitalization, etc.
SUSAR	Serious and unexpected adverse reaction needing expedited reporting.

📈 Reporting Timelines (ICH E2A)

Event	Timeline
Fatal or life-threatening SUSAR	Within 7 days, followed by a complete report in 8 additional days
Other SUSARs	Within 15 days
Annual DSUR	Once per year after IND filing

🧠 Summary for Interview or Exam

Aspect	Key Point
Purpose	Protect trial participants; collect safety data
Core Report	SAE, SUSAR, DSUR
Key Guidelines	ICH E2A, E2F, E6
Stakeholders	Sponsor, Investigator, Ethics Committee, Regulatory Authorities
Tools Used	CRFs, Safety Databases, EDC, MedDRA

📑 What You’ll Receive:

1. ✅ DSUR Template (Development Safety Update Report)

Cover Page
Executive Summary
Introduction
Worldwide Marketing Approval Status
Summary of Significant Findings (Nonclinical & Clinical)
Safety Evaluation
Actions Taken for Safety Reasons
Summary Tables (SAEs, SUSARs)
Conclusion

2. 🧾 AE vs SAE vs SUSAR Flowchart

Easy-to-follow diagram showing:
- How AEs are classified
- When they become SAEs
- When an SAE becomes a SUSAR
- Reporting timelines and recipients

3. 📊 PowerPoint Slide Deck

Title: Pharmacovigilance in Clinical Trials
6–8 slides covering:
- Importance
- Key Definitions (AE, ADR, SAE, SUSAR)
- Reporting Responsibilities (Sponsor vs Investigator)
- ICH Guidelines
- Timeline Table
- Real-world Case Example
- Summary

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Pharmacovigilance in Clinical Trials

Pharmacovigilance in Clinical Trials