Clinical Research: An Introduction

Foundational course covering the core components of the clinical research enterprise.

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About this Course


This course provides the basic concepts of what clinical research is, how it is carried out and by whom, and its underlying ethical and regulatory framework. It discusses the key principles of Good Clinical Practice such as data management and the protection of human subjects. It further explores specific issues in clinical research, including protocol design, critical regulations and oversight bodies, common types of clinical trials, regulatory compliance, and clinical research billing.

Note: The course provides an overview of the clinical research enterprise and its parts. It is meant to supplement (not replace) Human Subjects Research (HSR) and Good Clinical Practice (GCP) courses.

Language Availability: English

Suggested Audiences: Clinical Billing Professionals, Clinical Data Managers, Clinical Research Coordinators, Compliance Officers, Contract Research Organizations (CROs), Faculty and Post-Docs, IRB Administrators, IRB Members, Legal and Risk Management Staff, Research Administrators, Researchers, Sponsors, Students

Organizational Subscription Price: $500 per year/per site
Independent Learner Price: $99 per person

Demo Instructions

Course Content


Understanding U.S. Clinical Research New Content

This module explores the nature and purpose of clinical research, how it differs from clinical care, and the institutional and organizational conditions that shape the research enterprise. The module provides information on the pharmaceutical and medical device industries and regulatory oversight. It outlines the institutional roadblocks to an efficient research enterprise and also describes the role that clinical research plays for public health in general.

Recommended Use: Required
ID (Language): 20463 (English)
Author(s): Quincy Byrdsong, EdD, CIP, CCRP - Lipscomb University

Common Types of Clinical Trials New Content

This module walks the learner through different clinical trial types and study phases related to drug and medical device development. Learners explore common types of study designs, their various classifications, and how they address different research questions. The module also considers principles of quality by design and subject selection as they relate to the study design.

Recommended Use: Required
ID (Language): 20464 (English)
Author(s): Dawn N.L. Pittinger, MBA, CHRC, CRCP - Moffitt Cancer Center

Critical Regulations and Oversight Bodies New Content

This module summarizes ethical principles governing clinical research. It provides an overview of the FDA’s structure, jurisdiction, and regulatory functions and introduces the reader to IRBs. It discusses clinical investigations that generate the data to support FDA marketing applications and FDA enforcement of its requirements. Learners explore how investigations provide evidence that a new product is both safe and effective. The module touches on U.S. funding agencies’ requirements for clinical research and concludes with an overview of some major international GCP standards.

Recommended Use: Required
ID (Language): 20465 (English)
Author(s): Kris West, JD, MS - Council on Governmental Relations (COGR)

Overview of the Clinical Research Enterprise New Content

This module surveys the clinical research enterprise by focusing on the roles and responsibilities of different parties involved in clinical research administration, oversight, and operations. Learners examine the involvement of auxiliary offices as well as the use of different organizational structures to administer clinical research. The module concludes by contrasting sponsored research with non-sponsored research to identify common personnel and staffing practices.

Recommended Use: Required
ID (Language): 20466 (English)
Author(s): Quincy Byrdsong, EdD, CIP, CCRP - Lipscomb University

Overview of a Protocol and Designing a Clinical Trial New Content

This module describes protocol development and use in clinical research. It details how the protocol guides investigators, sponsors, monitors, and research stakeholders on how to conduct and oversee the trial. Learners will gain an appreciation of how a protocol helps regulators and ethics boards to understand study procedures and identify any risks for potential subjects. The module concludes with a discussion of study and investigator feasibility assessments.

Recommended Use: Required
ID (Language): 20467 (English)
Author(s): Melissa Byrn, MS, MBE - Polsky Center for Entrepreneurship and Innovation and University of Chicago

Data Management in Clinical Research New Content

This module introduces the sources of clinical data, how and where investigators collect data, and best practices for data management. It details how data is reported and the means of ensuring data quality, uniformity, and integrity across subject histories. Learners will explore methods for capturing and collecting data from paper sources, electronic health records, and other digital origins. The module concludes by identifying recent trends in best practices for data management.

Recommended Use: Supplemental
ID (Language): 20468 (English)
Author(s): Melissa Byrn, MS, MBE - Polsky Center for Entrepreneurship Innovation and University of Chicago

Ensuring Compliance New Content

This module defines compliance and outlines how it merges with ethics to encompass research integrity at an institution, site, or company. The module details how compliance with GCP serves core functions within clinical research. It reviews key areas of research compliance programs including policies and procedures, training and education, and risk assessments. Learners explore the application and limitations of privacy and confidentiality protections under HIPAA for research. The module concludes by outlining types of scientific misconduct and the means to prevent them.

Recommended Use: Supplemental
ID (Language): 20469 (English)
Author(s): Kelly Willenberg, DBA, RN, CHRC, CHC, CCRP - Kelly Willenberg & Associates

Overview of Clinical Research Billing New Content

This module highlights clinical trial budgeting and billing processes from a site perspective for industry sponsored clinical trials. It defines the components of a clinical research budget, discusses potential hidden costs for a research site, and identifies insurance billing requirements. The module concludes by detailing how good budgeting is important, how it relates to coverage analysis, and what guidelines and rules apply to research billing.

Recommended Use: Supplemental
ID (Language): 20470 (English)
Author(s): Marie Jackson, PhD, MBA - Methodist le Bonheur Healthcare


FAQs


Who should take the Clinical Research: An Introduction course?

The course is designed for individuals new to clinical research or looking to enter into a related field, including undergraduate and graduate students, university faculty and postdocs, research compliance officers, new clinical investigators, clinical research coordinators, research administrators, institutional officials, clinical data managers, and clinical billing professionals.

How does the Clinical Research: An Introduction course complement other CITI Program courses?

Clinical Research: An Introduction serves as a helpful precursor to taking CITI Program courses in the Good Clinical Practice (GCP) series, Human Subjects Research (HSR) series, and Responsible Conduct of Research (RCR) series. By providing a description of the conduct and context of clinical trials, this course provides leaners with the opportunity to better understand the regulatory and ethical dimensions of clinical research.

This course is not designed to replace other CITI Program courses (such as GCP, HSR, or RCR).

Why should someone take the Clinical Research: An Introduction course?

Learners who wish to gain a foundational understanding of the clinical research enterprise should take this course to prepare for a career in clinical research or to gain necessary knowledge for those roles interfacing with clinical researchers.

This course can be used in onboarding for those new to research, or for those taking on new roles that involve interaction with research offices or include research responsibilities.

How long will the course take a learner to complete?

This course consists of eight modules.  Each module contains detailed content and a quiz, as well as images, supplemental materials, and case studies.

Modules vary in length, and learners may require different amounts of time to complete them based on their familiarity and knowledge of the topic. As a rule of thumb, modules can take about 30 to 45 minutes to complete, which means it could take around four to six hours to complete all eight modules.

Is this course eligible for continuing medical education credits?

This course does not currently have CE/CME credits available.

What are the required and supplemental modules for learner groups?

This course is designed to be completed sequentially through its first five modules (we recommend they are set as “required”). The three following additional modules should be set for “supplemental.” These supplemental modules are recommended for individuals interested in those specific topics. The supplemental modules provide rich information relevant to clinical research but not essential for the learner to gain a foundational knowledge of clinical research.

Required

  • Understanding U.S. Clinical Research
  • Common Types of Clinical Trials
  • Critical Regulations and Oversight Bodies
  • Overview of the Clinical Research Enterprise
  • Overview of a Protocol and Designing a Clinical Trial

Supplemental

  • Data Management in Clinical Research
  • Ensuring Compliance
  • Overview of Clinical Research Billing

What are the advantages of the Clinical Research: An Introduction course?

This course provides peer-reviewed training written by clinical research experts. Along with CITI Program's advantages, including our experience, customization options, cost effectiveness, and focus on organizational and learner needs, this makes it an excellent choice for clinical research training.


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