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CRC Advanced

This course provides advanced CRC training.





About this Course

The CRC Advanced course provides clinical research professionals with advanced training tailored to the CRC’s critical role in the conduct of clinical trials.” It is designed for CRCs who have taken CRC Foundations, or those with two or more years of experience as a CRC. It complements the foundational course, and may be used for professional development and/or as a refresher course.

Disponibilidad del idioma: English

Audiencias sugeridas: Clinical Research Coordinators, Clinical Research Professionals, Investigators

Organizational Subscription Price: $350 per year/per site; $650 per year/site (total fee for subscribing to both CRC Foundations and CRC Advanced)
Independent Learner Price: $165 per person; $300 per person for combined option (CRC Foundations and CRC Advanced)

Course Content

Project Management for Clinical Trials New Content

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.

Uso recomendado: Required
ID (Idioma): 17864 (English)
Autor (es): Jessica Derr, BA, CCRC, CRCP - Texas Health Resources; Susan Leister, BS, MBA, PhD, CQA, CSSBB - Technical Resources International, Inc. and University of Phoenix

Preventing and Identifying Misconduct and Noncompliance New Content

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.

Uso recomendado: Required
ID (Idioma): 17865 (English)
Autor (es): Nancy Wintering, MSW, LCSW, CCRP - Thomas Jefferson University

Training and Mentoring New Content

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.

Uso recomendado: Required
ID (Idioma): 17866 (English)
Autor (es): R. Jennifer Cavalieri, BSN, RN, CCRC - University of Nebraska Medical Center; Mark E. Rupp, MD - University of Nebraska Medical Center

Subject Recruitment and Retention New Content

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.

Uso recomendado: Required
ID (Idioma): 17868 (English)
Autor (es): R. Jennifer Cavalieri, BSN, RN, CCRC - University of Nebraska Medical Center; Mark E. Rupp, MD - University of Nebraska Medical Center

Statistics and Data Management of Clinical Trials New Content

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.

Uso recomendado: Required
ID (Idioma): 17869 (English)
Autor (es): Farida Dabouz, PhD, CCRP - International Cancer Research Group (ICRG) and FB2D Clinical Research Consulting, Inc.

Specialty Areas and Regulatory Requirements New Content

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.

Uso recomendado: Required
ID (Idioma): 17870 (English)
Autor (es): Nancy Wintering, MSW, LCSW, CCRP - Thomas Jefferson University