Establishing a Clinical Research Program

The module describes the key considerations to establishing a clinical research site. It defines the regulatory requirements involved in clinical research. In addition, the module identifies strategies for obtaining funding sources for a research program.

Recommended Use: Required
ID (Language): 22243 (English)
Author(s): Ximena Levy, MD, MPH - Baptist Health South; Karin Scarpinato, PhD - Kennesaw State University

The module provides recommendations on how to compose a clinical research team. It defines the roles and responsibilities of each team member, along with summarizing the supervisory requirements of the principal investigator (PI).

Recommended Use: Required
ID (Language): 22244 (English)
Author(s): Ximena Levy, MD, MPH - Baptist Health South; Karin Scarpinato, PhD - Kennesaw State University

The module discusses the important of aligning a research portfolio with the demographics of the potential study population. It explains the components of establishing a research enterprise, including developing a business strategy, stabilizing cash flow and capital, training staff, developing market plans, and networking. The module also provides strategies for identifying sources of funding to build and support a research portfolio.

Recommended Use: Required
ID (Language): 22245 (English)
Author(s): Ximena Levy, MD, MPH - Baptist Health South; Karin Scarpinato, PhD - Kennesaw State University

The module describes document and data management requirements during a clinical trial, including the fundamental skills necessary to carry out role-specific tasks. It describes the basic procedures for data management in each phase of the study.

Recommended Use: Required
ID (Language): 22246 (English)
Author(s): Ximena Levy, MD, MPH - Baptist Health South; Laura Liranzo, MD - Headlands Research; Nicholas Toll, MS - JEM Research Institute, Lake Erie College of Osteopathic Medicine; Santiago Vanegas Rincon - Headlands Research

The module explains the role of sponsors and their agents, including clinical research organizations (CROs) and clinical research associates (CRAs), in clinical research. It describes their common interactions with principal investigators (PIs) and site staff. In addition, the module offers recommendations for best practices for communicating with sponsors.

Recommended Use: Required
ID (Language): 22247 (English)
Author(s): Ximena Levy, MD, MPH - Baptist Health South; Laura Liranzo, MD - Headlands Research

The module details clinical research regulations and the oversight of research. It explains the role of an Institutional Review Board (IRB), compliance committees, and the U.S. Food and Drug Admnistration (FDA). The module also offers a discussion of best practices for communicating and collaborating with these oversight bodies.

Recommended Use: Required
ID (Language): 22248 (English)
Author(s): Ximena Levy, MD, MPH - Baptist Health South