Best Practices for Participant Safety: Assessment, Documentation & Reporting of Adverse Events
Presented by: Elizabeth Ness, MS, BSN, RN, Ilana Logvinov, RN, MSN, CCRP, and Yolanda McKinney, RN, BSN, CCRC
Identifying and monitoring adverse events (AEs) is critical to protect research participants and ensure data integrity. Assessment of AEs and timely documentation and reporting is crucial to research participant safety and critical components of good clinical practice (GCP). This webinar will highlight best practices for the management of AEs in clinical trials by using exemplars to illustrate key concepts. Topics will include: elements of a quality AE assessment, accurate documentation, and reporting to IND sponsor and the IRB.
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Director, Office of Compliance and Education at Center for Cancer Research, NCI
Elizabeth (Liz) Ness brings with her over 35 years of nursing experience and 23 years of clinical research experience. She earned her BSN from Boston College and her MS in Nursing Education from the University of Maryland School of Nursing. Currently, she is the Director of the Office of Education and Compliance at the Center for Cancer Research (CCR), part of the intramural research program (IRP), at the National Cancer Institute in Bethesda, MD. Her primary responsibilities include coordinating, developing and evaluating both educational and quality management activities for the CCR. Prior to working for the NCI, Ms. Ness worked for three years with a firm in Bethesda, MD, two of those years as the Deputy Project Manager for the NCI Cancer Therapy and Evaluation Program Protocol and Information Office. For six years, Ms. Ness was the lead Research Nurse for the Developmental Therapeutics Clinic at Lombardi Cancer Center in Washington, D.C. She is an active member of the Oncology Nursing Society (ONS). She has helped ONS develop 2 web courses related to clinical trials and serves as an author, served as co-editor for the 3rd edition of the ONS Manual for Clinical Trials Nursing and the project team lead for the 2nd edition of the Clinical Trials Nurse Competencies. Ms. Ness is active in International Association of Clinical Research Nurses (IACRN) serving on the Education Committee and as lead nurse planner. In addition to presentations for orientation and other inservices, Ms. Ness has presented nationally and internationally on topics related to clinical trials and professional development at conferences and to cancer centers. Ms. Ness is also a teaching assistant at Drexel’s School of Nursing in the clinical trial research program.
Assistant Professor of Nursing and Instructor of Anesthesiology at Mayo Clinic College of Medicine
Ilana Logvinov is an Assistant Professor of Nursing and Instructor of Anesthesiology at Mayo Clinic College of Medicine. She has worked as a Registered Nurse for over 15 years. She is currently an Advanced RN Certified Clinical Research Coordinator for the Department of Anesthesiology at Mayo Clinic in Florida. Originally, she received her nursing degree from Odessa State School of Nursing in Odessa, Ukraine. After she moved to the United States, she received her Associate Degree in Nursing from Florida Community College at Jacksonville, her BSN from Jacksonville University, and her MSN from Drexel University. She is currently working on her doctorate with emphasis on nursing leadership. Ilana is a Silver Level Certified Mayo Clinic Quality Fellow and a Certified Clinical Research Professional. She received multiple honors and awards. In 2014 she was recognized as a transformational leader and received a Mayo Clinic Nursing Exemplar award. In 2015 she was recognized by the Lambda Rho Chapter-at-Large of Sigma Theta Tau for excellence in scholarship. Ilana has been published in various peer-reviewed journals, including Contemporary Clinical Trials; Anesthesia Analgesia; and Local Regional Anesthesia. She is a reviewer for the Contemporary Clinical Trials and Clinical Transplantation journals. Her primary interests are in perioperative patient management, protection of vulnerable population in research, improvement of consenting process in clinical trials, and nursing evidence-based practice.
Senior Research Nurse Specialist, Molecular Imaging Program at Center for Cancer Research, NCI
Yolanda has over 22 years of nursing experience with 14 years of clinical research experience. She earned her BSN from the Medical College of Georgia. Prior to working at the NCI, Ms. McKinney worked as a Staff Nurse for 5 years in the Emergency Department at University Hospital in Augusta, GA. For three years, she worked as Staff Nurse in the Interventional Radiology Department where she then transitioned to be the Research Nurse for the Diagnostic Radiology Department. There she implemented and coordinated clinical trials for the department. Currently, she is the Senior Research Nurse Specialist and Nurse Manager for the Molecular Imaging Program at the Center for Cancer Research at the National Cancer Institute in Bethesda, MD. She collaborates with the Molecular Imaging team of M.D.s, research fellows, medical physicists, clinical health associate, and technologists on the development, implementation, coordination, and management of their research protocols, while managing the day-to-day operations of the imaging clinic for both clinical and research patients. Finally, she serves a resource for her colleagues within the CCR on matters related to imaging and imaging procedures.