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Upon completion of this activity, learners will be able to:
Describe the different classifications or levels of protocol deviations.
Explain the reporting processes and consequences for protocol deviations.
Discuss the best practices to avoid protocol deviations.
References
21 CFR 312.60; 45 CFR 46.103 (b)(4)(iii) UAMS IRB Policy 8.1
UAMS IRB and Institutional Policies
Food & Drug Administration (FDA)
USDHHS The Office of Research Integrity
Speaker(s): Jessica Snowden, MD
Contributor(s): Jessica Snowden, MD, MS, MHPTT; Darri Scalzo, BA; Rebecca Cantu, MD, MPH; Catrice Banks-Johnson
Dr. Snowden is the Vice Dean for Research at the University of Arkansas for Medical Sciences (UAMS) College of Medicine and the Vice Chair for Research in the Department of Pediatrics. Dr. Snowden holds the Horace C. Cabe Distinguished Chair in Pediatric Infectious Disease and is the Associate Director for clinical and translational Research at Arkansas Children’s Research Institute (ACHRI). As Principal Investigator of the DCOC, Dr. Snowden directs clinical operations for trial implementation and professional development, as well as provides strategic DCOC leadership overseeing clinical trial activities for all ECHO ISPCTN trials to include clinical operations, IRB and regulatory issues, safety operations, budgetary oversight, and clinical trial training programs.
Darri Scalzo is a Senior Director at Ankura. She has over 30 years of experience in research compliance, research administration, and auditing, with special expertise in human subject research protections, animal research compliance, research misconduct, and research integrity. Darri has assisted academic medical centers, research organizations, and clinical practices build their research compliance programs; conducted assessments of the status of research compliance and research operations, the oversight of clinical trials, the clinical research revenue cycle including coverage analysis, budgeting and billing, and monitoring activities in place to ensure data integrity; conducted audits of coverage analysis processes and procedures; and recommended policies and procedures to improve compliance surrounding the clinical research revenue cycle and the conduct of clinical trials.
Dr. Cantu received her medical degree from Tulane University School of Medicine, then remained at Tulane for her pediatrics residency and a chief resident year. She completed a fellowship in pediatric hospital medicine at UAB. She is a pediatric hospitalist at ACH. She enjoys working with residents on teaching teams and her favorite topics of discussion are evidence-based & high-value care, demystifying clinical research, and breastfeeding. She is the program director of ACH’s new pediatric hospital medicine fellowship.
Catrice coordinates the ECHO ISPCTN Continuing Education (CE) activities including assisting with the development and implementation of clinical trials curriculum. Catrice assists with facilitating educational webinars, designing and developing research education courses, editing videos, and posting for ISPCTN Research Portal users. She analyzes and compiles course and learner data to make recommendations as needed and reports evaluation metrics of professional development results. Catrice troubleshoots issues with the Professional Development side of the ISPCTN Research Portal to include editing all DCOC training, educational, and profile videos.
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