Introduction to Clinical Research Online Modules

The Introduction to Clinical Research suite of online modules are designed to train research site staff in role-based courses. These roles include allied health staff, ancillary staff, patient care staff, financial staff and clinical research staff in the basic competencies of clinical research. The program consists of five, one-hour, asynchronous online modules developed using evidence-based principles in online learning development and instructional design.

Cost is $39.99 per course, or $149.95 total for bundle of all 5.

Register online.

Course offerings include:

Introduction to Clinical Research

This course is designed to give an overview of clinical research to all individuals working at a clinical research site. The course is appropriate for clinical and ancillary staff, as well as administrative and support staff working in a clinical setting where research takes place. The program will assist learners in defining clinical research and valuing their important role in appropriate conduct of clinical research.

Objectives:

  • Define clinical research
  • Identify roles that contribute to clinical trials within an organization
  • Describe the scope of clinical trials
  • Distinguish between research subjects and patients
  • Evaluate the impact of human subjects protections in clinical research
  • Recognize potential clinical research misconduct
Human Subjects Protections

This course is designed to give an overview of human subjects protections and to assist individuals in contributing to appropriate human subjects protections within an organization. The course is recommended for all audiences and career levels: it will serve as a refresher for experienced staff and ensure that all participants understand and can comply with the basic principles of human subjects protections.

Objectives:

  • Identify clinical research subjects
  • Define human subjects protections
  • Identify roles that contribute to human subjects protections implementation and oversight
  • Evaluate the role of the Institutional Review Board (IRB) in research
  • Discuss the impact of Health Insurance Portability and Accountability Act (HIPAA) on human subjects protections
  • Recognize the appropriate administration of informed consent
Good Clinical Practice

This course addresses patient care and is designed for clinical research and allied health staff. The course assists clinical staff in understanding their important role in Good Clinical Practice (GCP) compliance and aids in distinguishing between research and patient care. This distinction facilitates a better understanding between clinical research and patient care staff as they work together to follow the procedures and processes outlined in the protocol. 

Objectives:

  • Define the purpose of clinical trials and describe Good Clinical Practice (GCP)
  • Identify roles that contribute to GCP
  • Recognize the clinical trial development and data collection process
  • Describe the clinical research protocol
  • Differentiate between standard of care and GCP
Clinical Research Billing

Designed for finance, billing and account professionals within the clinical research organization, this course assists staff in understanding the importance of billing compliance and their role in the process. Participants will understand the significant risks associated with improper billing, Medicare, and the federal government in clinical trial billing compliance.

Objectives:

  • Differentiate between conventional patient billing and clinical research trial billing
  • Identify the roles that contribute to clinical trials billing compliance
  • Explain the role of Medicare in covering clinical trial costs
  • Describe fundamental clinical research biling procedures at the study site
  • Recognize risks associated with improper billing and identify best practices to minimize risks
Research Misconduct

This course is intended for clinical research professionals and investigators in need of an introduction to research misconduct issues. It clearly defines research misconduct and associated risks, explains the role of individuals in research misconduct prevention, and discusses the overall research misconduct process. Participants will understand the importance of avoiding research misconduct and their responsibility to report on potential misconduct to comply with federal regulations.

Objectives:

  • Define four types of research misconduct
  • Identify roles that are involved in research misconduct
  • Recognize and report research misconduct
  • Explain the process and role of the Office of Research Integrity (ORI) in research misconduct
  • Describe risks associated with research misconduct