Clinical Research: An Introduction

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

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

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)

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

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

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

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

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

This module discusses types of clinical research technologies used within clinical trial operations. It identifies how electronic systems enhance clinical trial compliance, improve site efficiencies, promote transparency in clinical trial conduct, and enhance safety and oversight of human research subjects. The module also explains the implications of the regulations at 21 CFR Part 11 on the implementation and use of computerized systems in clinical trials.

Recommended Use: Supplemental
ID (Language): 20471 (English)
Author(s): Candida Barlow, PhD, MSN, CRN-BC, RN - Oklahoma State University