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
-
🎓 Discover one of the best Pharmaceutical Pharmacovigilance course available — click below to explore the course that’s shaping future Pharmacovigilance skills.