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Clinical Trial Fundamentals eLearning Program


Overview

This eLearning program is designed to provide a practical context to help clinical research professionals learn about conducting clinical trials. Using an interactive case study with realistic scenarios designed to illustrate the learning points, the program follows the activities of a fictitious clinical investigator and her staff as they conduct a clinical trial.

The program is divided into three modules:

As learners make decisions during the clinical trial, the program explains how each scenario relates to the regulations, guidelines, and practices for conducting clinical trials. These three modules will take approximately 7.5 hours to complete.

 

Featured topics

  • Responsibilities of the investigator and sponsor
  • Study design and documents
  • Ethical considerations in clinical research
  • Responsibilities of the study staff
  • Institutional Review Boards
  • Informed consent and HIPAA
  • The investigator and study initiation meetings
  • Subject recruitment, selection, retention, and compliance
  • Classifying, recording, and reporting adverse events
  • Managing monitoring visits
  • FDA inspections

Who should attend?

This module is designed for those working for investigative site teams, sponsors, or CROs, including clinical investigators, research coordinators, office coordinators, nurses, physician assistants, clinical research coordinators, and other professionals involved in clinical trials.

  • Physicians
  • Pharmacists
  • Physician assistants
  • Nurse practitioners
  • Research scientists
  • Clinical research professionals
     

Learning objectives

Study Preparation: Upon completion of this module, learners should be able to:

  • Differentiate the roles and responsibilities of the clinical investigator, the study staff, and the sponsor
  • Identify the clinical phases of drug development and what is done at each phase
  • Discuss the regulations and Good Clinical Practice guidelines on conducting a clinical trial
  • Explain the foundations of ethical conduct in clinical research including its impact on clinical research 
  • Explain the history behind human subject protection
  • Explain different study designs and discuss the merits of each
  • Explain how to determine a study budget

Study Initiation: Upon completion of this module, learners should be able to:

  • Describe the roles and responsibilities of the Institutional Review Board/Independent Ethics Committee
  • Explain the correct way to complete the FDA Form 1572
  • Describe financial disclosure requirements of the clinical investigator and study staff
  • Identify the elements of the informed consent document, including HIPAA authorization 
  • Identify the documents necessary to submit to the IRB before a study begins
  • Identify the purpose, attendees, and activities of the study initiation meeting and the investigator meeting
  • Explain how clinical trial files should be organized

Conducting the Study: Upon completion of this module, learners should be able to:

  • Appropriately employ methods for successful subject recruitment, selection, retention, and compliance
  • Properly apply the informed consent process during a clinical trial
  • Classify, record, and report adverse events
  • Manage monitoring visits
  • Describe how to prepare for an FDA inspection, the process of the inspection, and potential consequences for being noncompliant
  • Identify the steps in preparing a post-study critique and study closure

 

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