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.
- 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.
- Protecting subjects
- Consent forms
- Consent process
- Consent exceptions
- Procedures and records
For the entire course library with descriptions please download the UL and AdvaMed Course Guide.