Clinical

Bioresearch Monitoring Program (BIMO): Introduction

This is the first in a series of courses that provide an overview of FDA’s Bioresearch Monitoring (BIMO) program and the methods and techniques used in conducting and reporting Nonclinical Laboratory, Clinical Investigator, Institutional Review Board (IRB), Sponsor/Monitor, and in vivo Bioequivalence inspections. This course provides an overview and historical perspective of FDA’s BIMO program.

Topics include:

Evolution of FDA’s regulatory history
BIMO terminology
The purpose of FDA’s BIMO program
Regulations and expectations that are part of FDA’s BIMO program
How FDA implements the clinical BIMO program

Protection of Human Subjects in Clinical Trials

This course provides the learner with a working knowledge of informed consent regulations, Institutional Review Board / Independent Ethics Committee responsibilities, and the obligations of the individuals responsible for protecting patient rights and welfare.

Topics include:

Protecting subjects
Consent forms
Consent process
Consent exceptions
IRB/IEC
Responsibilities
Procedures and records

Clinical

Bioresearch Monitoring Program (BIMO): Introduction

Topics include:

Protection of Human Subjects in Clinical Trials

Topics include:

For the entire course library with descriptions please download the UL and AdvaMed Course Guide.