Medical Monitoring for Drugs and Biologics

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.

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.

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.

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.

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.