Provides an introduction to the CRC course.

Recommended Use: Required
ID (Language): 16682 (English)

Discusses the planning aspects of clinical trials, including the overall clinical trial process, associated activities, and the roles and responsibilities of key clinical research team members.

Recommended Use: Required
ID (Language): 16751 (English)
Author(s): Deena Bernstein, MHS - Sheridan Clinical Research, Inc.; Eunjoo Pacifici, PharmD, PhD - University of Southern California

Identifies the steps involved in the process of clinical trial budgeting, funding, and financial management. It describes funding types, distinguishes the difference between pre-award and post-award financial activities and compliance requirements, and identifies some of the challenges associated with developing a clinical trial budget. It also explains coverage analysis and basic Medicare Clinical Trials Policies.

Recommended Use: Required
ID (Language): 16752 (English)
Author(s): Holly Weisbuch, MS, CCRP - City of Hope

Explains the function of the Institutional Review Board/Independent Ethics Committee (IRB/IEC) and the various forms of communication and information exchange that occur between the CRC and the IRB/IEC throughout the course of a research study. It discusses types of IRB/IEC review and submission, essential documents, adherence to IRB/IEC approved protocol/protocol compliance, protocol deviation and violation reporting, data protection plans and data/safety monitoring, considerations for compensation/payment to subjects, subject recruitment and advertising, adverse event reporting, and the Federalwide Assurance (FWA).

Recommended Use: Required
ID (Language): 16753 (English)
Author(s): Susan Pusek, MS - North Carolina Translational and Clinical Sciences Institute/University of North Carolina at Chapel Hill; Katherine Hawthorne, RN, BS - Keck School of Medicine of USC/University of Southern California

Provides an overview of the different ancillary committees involved in the review of clinical trials. It identifies the responsibilities of different review committees, including radiation safety and biosafety, and discusses various data safety monitoring requirements for research as mandated by the National Institutes of Health (NIH), the U.S. Food and Drug Administration (FDA), and ICH GCP guidelines. It also summarizes elements of an effective strategy for identifying and managing committee review requirements.

Recommended Use: Required
ID (Language): 16754 (English)
Author(s): Jennifer Hagemann, MS - University of Southern California

Describes the PI’s responsibilities in clinical research and emphasizes the responsibilities typically held and not delegated. It includes study team training and study task delegation, adverse event assessment and reporting, feasibility assessment and other sponsor issues, study documentation and data management, drug storage and sample processing, monitoring visits and federal audits, subject enrollment and informed consent, and authorship and publication.

Recommended Use: Required
ID (Language): 16755 (English)
Author(s): Anjenette Kirk, MEd - Cincinnati Children's Hospital Medical Center; Mina Busch, MS, CCRP, CIP - Cincinnati Children's Hospital Medical Center

Focuses on the general nature of skills involved with coordinating clinical research. It reviews tasks traditionally completed by the CRC, and identifies documents and documentation practices essential to the coordination of clinical research.

Recommended Use: Required
ID (Language): 16756 (English)
Author(s): Mina Busch, MS, CCRP, CIP - Cincinnati Children's Hospital Medical Center; Anjenette Kirk, MEd - Cincinnati Children's Hospital Medical Center

Discusses sponsor responsibilities during the conduct of a clinical investigation. It defines whom the sponsor is, the sponsor’s responsibilities, and the relationship that exists between sponsors and investigators.

Recommended Use: Required
ID (Language): 16757 (English)
Author(s): Leslie Korbee, BS, SI (ASCP), CCRA - Cincinnati Children's Hospital Medical Center

Focuses on the informed consent process from the CRC’s perspective. It defines PI and CRC roles and responsibilities in the informed consent process, and strategies to improve the informed consent process.

Recommended Use: Required
ID (Language): 16758 (English)
Author(s): Jennifer Hagemann, MS - University of Southern California

Reviews clinical research site requirements, and some of the management structures and shared resources that a CRC might encounter, including information about research site staffing and facilities management. Information is included to familiarize CRCs with some of the requirements for specimen processing, which is often a key part of the CRC role. It introduces the concept of research integrity, provides examples of research misconduct cases in clinical trials, and reviews procedures for assuring quality at the clinical research site. It also discusses the ways in which information about ongoing and completed trials is made available to scientists and the public.

Recommended Use: Required
ID (Language): 16759 (English)
Author(s): Holly Weisbuch, MS, CCRP - City of Hope

Provides CRCs with resources and tools that can be used to assist daily tasks, support regulatory compliance, and promote best practices. This includes, for example, links to job aids, templates, forms, regulations, and other helpful websites.

Recommended Use: Required
ID (Language): 16774 (English)
Author(s): Jennifer Hagemann, MS - University of Southern California

Organizations may use this module to deliver information specific to conducting clinical trials at their site.

Recommended Use: Supplemental
ID (Language): (Multiple Languages Available)

Discusses the general purpose of a CTA, roles and responsibilities of parties to the CTA, and how the CTA fits into the research enterprise. It also compares and contrasts clinical trials involving drugs, biologics, and devices from a CTA perspective.

Recommended Use: Supplemental
ID (Language): 17356 (English)
Author(s): Dex Bilkic, HBSc, MBA - Boehringer-Ingelheim; JoAnn Pfeiffer, DrSC, RAC, CCRA - Arizona State University

Provides an overview of the context behind certain CTA terms and sections, types of language used for CTA sections, and some key elements of each section. It also outlines what should be addressed in the key sections of the CTA and the aim for each section.

Recommended Use: Supplemental
ID (Language): 17357 (English)
Author(s): Dex Bilkic, HBSc, MBA - Boehringer-Ingelheim; JoAnn Pfeiffer, DrSC, RAC, CCRA - Arizona State University

Discusses key roles of the researcher and site in managing the CTA, including initial assessment, review, and implementation. It also describes how the CTA is linked to site policies, the protocol, and the informed consent form, and identifies key sections of the CTA that could present risk to the site.

Recommended Use: Supplemental
ID (Language): 17358 (English)
Author(s): Dex Bilkic, HBSc, MBA - Boehringer-Ingelheim; JoAnn Pfeiffer, DrSC, RAC, CCRA - Arizona State University

Addresses strategies and preparation for CTA and study budget negotiations. It also identifies terminology and alternative wording options to ensure a fair and balanced CTA.

Recommended Use: Supplemental
ID (Language): 17359 (English)
Author(s): Dex Bilkic, HBSc, MBA - Boehringer-Ingelheim; JoAnn Pfeiffer, DrSC, RAC, CCRA - Arizona State University