Understanding & Managing the US Clinical Trial Process

Clinical trials are an essential part of the evaluation of safety and efficacy for new drugs, biologics and medical devices, and are critical to obtaining regulatory approval as the final milestone in product development. As a regulatory professional, you have a significant role in clinical trial management, so it is imperative that you understand the clinical research process and basic issues associated with the infrastructure elements required for the successful management of clinical trials.

This course provides an overview of the foundation for clinical trials in the US, including their historical evolution, ethical conduct and regulations and the responsibilities of parties involved in clinical research. The types and phases of clinical trials and protocol development, as well as key issues related to clinical trial management and monitoring, are reviewed from a regulatory perspective.




  • At A Glance
  • Learning Objectives
  • Lesson Titles
  • Learning Activity
  • Registration Options

At A Glance

  • Target Audience: This course is designed for new personnel in regulatory, quality assurance, compliance, clinical operations and other related departments.
  • Learning Level: Basic
  • Total Length of Course: 4–8 Hours
  • RAC Credits: 4
  • Formats: PC and Tablet (iPad and Android)
  • Cost: Member $455; List $630
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Learning Objectives

Upon completion of this course, students should be able to:

  • Discuss the history and evolution of clinical trials
  • Identify the importance of informed consent to the clinical research process
  • Describe the major requirements in each applicable Code of Federal Regulations (CFR) section related to clinical research
  • Outline the steps of clinical trial development and execution
  • Distinguish between different types and phases of clinical trials
  • Outline the roles and responsibilities for conducting clinical trials
  • Describe the regulatory issues related to data management during a clinical trial

Lesson Titles

  • Lesson 1: Foundations of Clinical Trials
  • Lesson 2: Code of Federal Regulations Related to Clinical Trials
  • Lesson 3: Structuring a Clinical Trial
  • Lesson 4: Maintenance and Monitoring
  • Lesson 5: Clinical Trial Data

Learning Activity

OU_ClinicalTrials_SS

This scenario-based activity lets you practice your regulatory decision-making in a safe and interesting way. Follow the events of a hypothetical story, gain important background information and hear stakeholder opinions before having to make choices about various regulatory issues. Then, see how those choices impact the story, company, product and characters. Complete this activity multiple times and see how things can change when you vary even one of your choices.

Registration Options

This course is available for purchase as follows: