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Clinical Trial Management Comprehensive eLearning Bundle


Overview

This eLearning bundle includes the Clinical Trial Fundamentals eLearning Program and the Informed Consent: Comprehensive Concepts and Components module. The self-paced courses are mobile compatible and learners will have access for one full year to complete them. Learning at your fingertips anywhere, anytime, and at a time that works for you!

The Clinical Trial Fundamentals eLearning Program includes three self-paced modules 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 prepare for, initiate and conduct a clinical study. As learners make decisions during the clinical trial, the program illustrates how clinical trial regulations and guidelines impact each situation, and the complex details of clinical trial study management.

The Informed Consent: Comprehensive Concepts and Components module provides an in-depth review of the key concepts of informed consent. It explains the components of a complete and appropriate consent form as specified by the International Conference on Harmonisation (ICH) and the US Food and Drug Administration (FDA), as well as guidance for the creation and appropriate wording of these components. It also includes a discussion on the benefits and concerns with electronic informed consent, and presents publications and projects that explore the use of eConsent.

The four modules will take an average of 11 hours to complete.

Featured topics

  • Responsibilities of the investigator and sponsor
  • Study design and documents
  • Responsibilities of the study staff
  • Institutional Review Boards
  • Elements of Informed Consent and HIPAA
  • eConsent
  • 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 professionals involved in:

  • Clinical research including research scientists, clinical research associates, study coordinators, clinical trial recruiters, principal investigators, nurses, physician assistants, office coordinators, and clinical study team
  • Regulatory affairs

Learning objectives

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
  • 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
  • Appropriately employ methods for successful subject recruitment, selection, retention, and compliance
  • Define informed consent and identify the key characteristics of the process
  • Identify situations that would require informed consent, and exceptions to consent
  • Explain the proper methods of communicating with and gaining consent from various populations of potential study subjects
  • Explain the proper use of electronic consent, its benefits, and concerns with its use
  • Identify common problems with completed consent forms
  • Write a complete and appropriate consent form
  • Determine which consent form components are necessary based on the characteristics of the study and potential study subjects
  • Analyze completed consent forms for comprehensiveness, appropriateness, and accuracy
  • Describe the difference between short and long consent forms, and explain when each is appropriate
  • Summarize informed consent requirements under HIPAA
  • 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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