Medical Monitoring in Clinical Trials
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|---|---|---|---|---|
| No sessions are planned at this time, however if you are interested in taking this course click here | ||||
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About this course
Reasons to attend
Gain the practical skills you need to confidently manage clinical trial safety. This hands-on 1-day course covers everything a Medical Monitor needs to know – from adverse event reporting and MedDRA coding to developing medical monitoring plans. Leave with ready-to-use tools, not just theory.What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
Course schedule
We provide this course in two distinct formats: Classroom OR Online| 1-Day face-to-face: 09:00 - 17:00 | 2 webinar sessions of 3 hours |
Course Description
Medical monitoring is at the heart of patient safety in clinical trials – yet many professionals step into the role without structured training on what it actually involves day to day. This practical 1-day course changes that.Designed and delivered by an experienced clinical research physician, you will work through the complete medical monitoring workflow: managing serious adverse events (SAEs), reviewing AE listings and MedDRA coding, contributing to safety documents like protocols and informed consent forms, and developing your own Medical Monitoring Plan.
What makes this course different? Every session includes hands-on exercises with realistic case studies. You will not just learn the theory – you will practise reviewing SAE cases, drafting a Medical Monitoring Plan, responding to medical site queries, and preparing safety communications. By the end of the course, you will have a personal action plan to apply in your very next working week.
Whether you are new to the Medical Monitor role or looking to formalise skills you have picked up on the job, this course gives you a structured, comprehensive foundation in clinical trial safety monitoring.
Programme highlight
- Role and responsibilities of the Medical Monitor in clinical trial safety
- Reporting and registration of Serious Adverse Events (SAEs) – with case exercises
- Understanding SUSARs, DSURs, and PSURs – your role in product-level safety reporting
- Reviewing AE listings, MedDRA coding, and expectedness/causality assessment
- Introduction to safety signal detection in clinical trials
Learning objectives
At the end of this course, participants will be able to:
- Manage clinical trial safety responsibilities confidently as a Medical Monitor
- Report and follow up on serious adverse events using a structured workflow
- Identify key safety data points and understand how they feed into medical monitoring responsibilities
Who should attend
This course is designed for medical and clinical research professionals involved in clinical trial safety. It is ideal for Medical Monitors, Clinical Research Physicians, Pharmacovigilance Scientists, Clinical Scientists, PharmDs, and senior Clinical Operations professionals working in pharmaceutical, biotech, or CRO settings. A background in life sciences, medicine, pharmacy, or a related discipline is expected, but no prior medical monitoring experience is required – we start from the fundamentals. Whether you are stepping into a safety-focused role for the first time or looking to strengthen your medical monitoring knowledge, this course will give you a solid practical foundation.
Competencies
This course covers competencies that are part of the ECCRT Competency Framework.
- Scientific Concepts & Research Design ()
- Ethical & Participants Safety Considerations ()
- Investigational Product Development and Regulation ()
- Clinical Studies Operations (GCPs or ISO 14155) ()
- Study and Site Management ()
- Data Management and Informatics ()
- Leadership and Professionalism ()
- Communication ()
- Teamwork ()
- Business acumen ()
Trainers
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