Overview

This module provides practical information to help professionals conduct safe, effective, and compliant clinical trials successfully. It explores essential responsibilities, including subject identification, enrollment, and retention; the informed consent process; adverse event classification and reporting; monitoring visits; FDA inspections; compliance considerations; and study closure activities. To reinforce learning, a fictitious yet realistic clinical trial study is used throughout the lessons to demonstrate how these concepts apply in practice.

This ICH E6 R3 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma Inc. as necessary to enable mutual recognition of GCP training among trial sponsors.

The module takes an average of 3 hours to complete.

This eLearning module can be purchased individually or as part of the Clinical Trial Fundamentals eLearning Program or Clinical Trial Management Comprehensive eLearning Bundle.

Featured topics

Subject recruitment
Subject enrollment
Classifying and reporting adverse events
Retaining subjects and managing compliance
Monitor visits, sponsor audits, and FDA inspections
Study Closure
After the Study

Who should attend?

This module is designed for professionals working for investigative site teams, sponsors, or CROs, including:

Physicians
Pharmacists
Physician assistants
Nurse practitioners
Research scientists
Clinical research professionals
Clinical investigators
Office coordinators
Other professionals involved in clinical trials

Learning objectives

At the conclusion of this course, participants should be able to:

Evaluate methods and guidelines for recruiting subjects for a clinical trial.
Identify non-compliance and subject retention issues.
Apply the appropriate informed consent procedures when enrolling subjects.
Determine adverse event classification and reporting responsibilities.
Recognize the three Establishment Inspection Report classifications and potential consequences of unfavorable observations from an FDA Inspection.
Outline study closure procedures.

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Clinical Trials Fundamentals: Conducting the Study

Overview

Featured topics

Who should attend?

Learning objectives

Be informed and stay engaged.