Comprehensive CRC

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): Anjenette Kirk, MEd - Cincinnati Children's Hospital Medical Center; Mina Busch, MS, CCRP, CIP - 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 are 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

Provides an overview of project management principles, how the principles can be applied to managing clinical trials, and how using project management methodologies can increase trial efficiency by minimizing omissions and redundant activities. This module also discusses tools that CRCs can use to help manage a clinical trial.

Recommended Use: Required
ID (Language): 17864 (English)
Author(s): Jessica Derr, BA, CCRC, CRCP - Texas Health Resources; Susan Leister, BS, MBA, PhD, CQA, CSSBB - Technical Resources International, Inc. and University of Phoenix

Describes the CRC’s role in preventing and identifying misconduct and noncompliance in clinical research, and provides strategies for investigating issues, performing a root cause analysis, and creating a corrective action plan.

Recommended Use: Required
ID (Language): 17865 (English)
Author(s): Nancy Wintering, LCSW, CCRP - Thomas Jefferson University

Presents practical strategies for experienced CRCs to orient new CRCs, including development of standardized orientation programs that cover essential domains. Discusses continued training and professional development for experienced CRCs, such as mentoring and self-directed learning.

Recommended Use: Required
ID (Language): 17866 (English)
Author(s): R. Jennifer Cavalieri, BSN, RN, CCRC - University of Nebraska Medical Center; Mark E. Rupp, MD - University of Nebraska Medical Center

Provides an overview of budget formulation and cost identification, discusses subject remuneration and reimbursement, reviews complex billing issues (including Medicare), identifies how to avoid fraud and abuse in billing, and concludes with the importance of budget reconciliation.

Recommended Use: Required
ID (Language): 17867 (English)
Author(s): Susan Leister, BS, MBA, PhD, CQA, CSSBB - Technical Resources International, Inc. and University of Phoenix

Identifies regulatory considerations associated with subject recruitment. Discusses the steps in developing a subject recruitment plan, strategies for approaching subjects, barriers to study participation, and challenges and strategies for subject retention.

Recommended Use: Required
ID (Language): 17868 (English)
Author(s): R. Jennifer Cavalieri, BSN, RN, CCRC - University of Nebraska Medical Center; Mark E. Rupp, MD - University of Nebraska Medical Center

Describes the role of statistics and informatics in research, including an overview of different study designs and the application of biostatistics to determine sample size. The module also discusses clinical data management and the significance of data quality.

Recommended Use: Required
ID (Language): 17869 (English)
Author(s): Farida Dabouz, PhD, CCRP

Provides a brief overview of several specialty areas and regulations that CRCs may encounter in the conduct of clinical research with investigational products, including: electronic records, systems, and signatures; research with biologics; good manufacturing practice (GMP); and shipping and receiving hazardous and dangerous goods.

Recommended Use: Required
ID (Language): 17870 (English)
Author(s): Nancy Wintering, LCSW, CCRP - Thomas Jefferson University

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 - Bayer Inc.; 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 - Bayer Inc.; 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 - Bayer Inc.; 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 - Bayer Inc.; JoAnn Pfeiffer, DrSC, RAC, CCRA - Arizona State University