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Clinical Trial Fundamentals eLearning Program

Learn about the regulations, guidelines, and practices for conducting clinical trials in this three module 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 Clinical Trial Fundamentals eLearning Program is divided into three modules:

  • Clinical Trials: Study Preparation
  • Clinical Trials: Study Initiation
  • Clinical Trials: Conducting the Study

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.

This ICH E6 R2 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 3 modules will take an average of 7 hours to complete.

Featured topics

  • Roles and Responsibilities
  • Good Clinical Practices
  • Drug Development Legislation
  • Ethical Considerations in Clinical Research
  • Study Documents
  • Clinical Trial Phases
  • Study Design
  • Use of Placebo
  • Site Evaluation Visit
  • Study Budget
  • The Contract
  • FDA Form 1572
  • Financial Disclosure
  • Institutional Review Board
  • Informed Consent and HIPAA
  • Continued IRB Involvement
  • Study Initiaion Documents
  • Investigator Meeting and Study Initiation Visit
  • Investigator Study Files
  • Finding Study Subjects
  • The Informed Consent Process
  • Enrolling the First Subjects
  • Classifying and Reporting Adverse Events
  • Preparing for a Monitor Visit
  • Subject Recruitment Issues
  • Retention of Subjects
  • Ongoing Subject Recruitment
  • Final Subject Selection
  • Managing Compliance
  • FDA Inspections
  • Study Closure
  • After the Study

Who should attend?

These modules are 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: After completing this activity, you should be better 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 clinical trial regulations and Good Clinical Practice guidelines on conducting a clinical trial and essential documents
  • 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: After completing this activity, you should be better able to:

  • Describe the roles and responsibilities of the Institutional Review Board or 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 study files should be organized before the study starts

Conducting the Study: After completing this activity, you should be better able to:

  • Appropriately employ methods for successful subject recruitment, retention, and compliance
  • Properly apply the informed consent process during a clinical trial
  • Classify, record, and report adverse events
  • Manage monitoring visits
  • Describe FDA inspection details including preparation, the inspection process, and consequences for regulatory violation
  • Identify the steps in preparing a post-study critique and study closure

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