Medical Monitoring for Drugs and Biologics

Foundational course covering the essential components of medical monitoring.

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About this Course

This course prepares medically trained individuals to become new medical monitors and enhances the knowledge of current medical monitors. Medical monitors participate as team members in clinical trials and have a key role in U.S. Food and Drug Administration-regulated research of drugs and biologics. The course describes the advice and input that medical monitors provide to sites and sponsors. It details their role in working with investigators to assess adverse events under 21 CFR 312. It also reviews the role monitors play in safety reporting to regulatory agencies and Institutional Review Boards. Lastly, the course provides learners with an overview of drug safety and pharmacovigilance.

Note: The course provides foundational role-based training for clinical research professionals. The course covers information that expands beyond but is directly connected to Human Subjects Research (HSR) and Good Clinical Practice (GCP) courses. Learners should have completed these basic courses prior to taking this course.

Course Preview:

Language Availability: English

Suggested Audiences: Clinical Research Associates (CRAs), Clinical Research Coordinators, Contract Research Organizations (CROs), Drug Safety Officers, Faculty, Medical Monitors, Principal Investigators, Research Administrators, Researchers, Sponsors, Students

Organizational Subscription Price: $675 per year/per site for government and non-profit organizations; $750 per year/per site for for-profit organizations
Independent Learner Price: $99 per person

Demo Instructions


Course Content

Introduction to Medical Monitoring

This introductory module outlines the various roles of medical monitors in clinical research. It provides an overview of the stepwise drug development process and details the relationships among internal and external stakeholders involved in clinical research. This module further gives an initial survey of the multifaceted area of drug safety and the critical role that the medical monitor plays in ensuring the protection of human subjects.

Recommended Use: Required
ID (Language): 20765 (English)
Author(s): Richard Paul, MD - Drug Development Associates, LLC and Capital Health Inc.

Providing Advice and Input to Sponsors and Sites

This module covers how medical monitors use their scientific and therapeutic backgrounds to monitor a clinical trial, from informing the protocol's design to reviewing adverse events experienced by subjects during the study. It explores the common study-related documents medical monitors review and how they provide advice and input to sponsors and sites. The module also outlines the core elements of the medical monitoring plan.

Recommended Use: Required
ID (Language): 20766 (English)
Author(s): Richard Paul, MD - Drug Development Associates, LLC and Capital Health Inc.

Assessing Adverse Events (AEs) and Serious Adverse Events (SAEs)

Medical monitors play a key role in adverse event (AE) and serious adverse event (SAE) reporting. They provide the medical assessment of relatedness and expectedness that informs claims of causality. This module reviews AE and SAE reporting criteria and discusses the medical monitor’s role in safety oversight. It also describes how the medical monitor works with other safety team members to assess AEs and SAEs.

Recommended Use: Required
ID (Language): 20767 (English)
Author(s): Richard Paul, MD - Drug Development Associates, LLC and Capital Health Inc.

Safety Reporting to Regulatory Agencies and Institutional Review Boards (IRBs)

This module extends the analysis from prior modules to describe how different federal agencies, such as the U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP), have different reporting requirements.

Recommended Use: Required
ID (Language): 20768 (English)
Author(s): Richard Paul, MD - Drug Development Associates, LLC and Capital Health Inc.

The Basics of Drug Safety and Pharmacovigilance

This module provides an overview of drug safety and pharmacovigilance (PV) issues relevant to medical monitors who engage with clinical drug development and safety teams. The module explains essential safety surveillance concepts and fundamental signal detection and risk mitigation steps. It further reviews U.S. Food and Drug Administration (FDA) guidance on assessing and reporting safety issues and best practices for analyzing and reporting safety data.

Recommended Use: Required
ID (Language): 20769 (English)
Author(s): Richard Paul, MD - Drug Development Associates, LLC and Capital Health Inc.


FAQs

Who should take the Medical Monitoring for Drugs and Biologics course?

The course can be used as foundational role-based instruction for new and aspiring medical monitors needing training for safety oversight of clinical research. It can also be useful for organizations needing onboarding training for new medical monitors. The intended audience includes new medical monitors, principal investigators, faculty and postdocs, students, clinical research coordinators, clinical research associates, and research administrators who work in academia, government, industry, and contract research organizations.

How does the Medical Monitoring for Drugs and Biologics course complement other CITI Program courses?

Medical Monitoring for Drugs and Biologics complements CITI Program’s other courses covering clinical research stakeholders involved in safety oversight, including the Biomedical Principal Investigator (PI) course and the Clinical Research Coordinator series. The course covers information that expands beyond but is directly connected to Human Subjects Research (HSR) and Good Clinical Practice (GCP) courses. Learners should have completed their HSR and GCP basic courses prior to taking this course.

How long will the course take a learner to complete?

Modules vary in length, and learners may require different amounts of time to complete them based on their familiarity and knowledge of the topic. However, they can complete them at their own pace. The entire course can be completed in about three hours.

Is this course eligible for continuing medical education credits?

This course does not currently have CE/CME credits available.

What are the required modules for learner groups?

This course is designed to be completed sequentially through its five modules (we recommend they are set as “required”).

Required modules:

  • Introduction to Medical Monitoring
  • Providing Advice and Input to Sponsors and Sites
  • Assessing Adverse Events (AEs) and Serious Adverse Events (SAEs)
  • Safety Reporting to Regulatory Agencies and Institutional Review Boards (IRBs)
  • The Basics of Drug Safety and Pharmacovigilance

What are the advantages of CITI Program's Medical Monitoring for Drugs and Biologics?

This course provides role-specific, peer-reviewed training written by an expert medical monitor. Along with CITI Program's advantages, including our experience, customization options, cost-effectiveness, and focus on organizational and learner needs, this makes it an excellent choice for medical monitoring training.


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