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Clinical Trial Fundamentals eLearning Program

Clinical Trial Fundamentals eLearning Program (all three modules!)

This 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 their 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 online program includes three self-paced modules that can be accessed anytime, anywhere for one year.

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Module 1- Clinical Trials: Study Preparation

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

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Module 2- Clinical Trials: Study Initiation

Featured Topics:

  • FDA Form 1572
  • Financial disclosure
  • Institutional Review Board
  • Informed consent and HIPAA
  • Study initiation documents
  • The investigator meeting and the study initiation meeting
  • Investigator study files

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Module 3- Clinical Trials: Conducting the Study

Featured Topics:

  • Subject recruitment, selection, retention, and compliance
  • Applying the informed consent process during a clinical trial
  • Classifying, recording, and reporting adverse events
  • Managing monitoring visits
  • FDA inspections
  • Post-study critique and study closure

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