WND108 Introduction to Clinical Research and Compliance
Jeffrey A. Niezgoda, MD, FACHM, MAPWCA, CHWS (Course Director)
Caroline E. Fife, MD, FACHM, MAPWCA
Kathy Goldstein, PhD, CCRA
Kazem Kazempour, PhD
Mukesh Kumar, PhD, RAC
Mark Nixon, MD
Thomas E. Serena, MD, FACS, FACHM, MAPWCA
Tyler Sexton, MD, CHWS, CHT, DMT
Christine Shettel, RN, BSN, CHWS, DAPWCA, PWRC
This course is designed for physicians, podiatrists, mid-level practitioners, nurses, physical therapists, and other allied health professionals working with the field of wound care with an interest in active participation in research based activities.
TOPICS AND EDUCATIONAL CONTENT
This course offers an introduction to wound care research and overview of the principles of conducting and participating in research based activities. Lectures will provide basic training in Good Clinical Practices (GCP) and research methods, basic statistics, trial design, guidelines and compliance for conducting research in chronic wounds. The research related opportunities as well as the challenges in wound healing trials will be presented by experts with extensive experience in the field.
PURPOSE FOR THE ENDURING MATERIAL
This course is intended to provide a comprehensive overview and introduction to conducting clinical research in the field of wound care. The expert faculty deliver rich content through a multimedia experience delivered from the comfort of your home or office.
This course will provide a comprehensive overview and introduction to conducting clinical research in the field of wound care. At the conclusion of this educational activity, participants should be able to:
- Define terminology common to clinical research practice.
- Perform clinical research within Good Clinical Practices standards and list the essential points of GCP.
- Describe the role and responsibilities of the Principle Investigator, the Contract Research Organization and Research Sponsor in clinical research.
- Illustrate the challenges in conducting research and describe how to avoid pitfalls in clinical trials.
- Describe the importance of protecting human rights in research and explain the informed consent process.
- Understand how to avoid conflict of interest while conducting clinical research.
- Interpret the results of a clinical trial and identify how a trial is powered to achieve significant results.
- Understand the importance of excellent clinical skills in the areas of debridement, compression therapy, wound measurement and assessment in the performance of wound research.
ESTIMATED TIME TO COMPLETE THE EDUCATIONAL ACTIVITY
Introduction to Clinical Research and Compliance is offered without accompanying Continuing Medical Education credits. It is estimated that the time to complete this education activity is approximately 10 hours.