Audit Trends: Issues, Findings and Remedies
Dawn Lowe-Gooden, MS, CQA
Download the Audit Trends presentation
Ms. Lowe-Gooden is the research compliance manager in the Office of Research Compliance and Regulatory Affairs (ORCRA) at Cincinnati Children's. Dawn has 20 plus years of quality assurance, compliance and regulatory experience in pharmaceutical testing and manufacturing, blood and tissue banking, and in academic health care settings. Ms. Lowe-Gooden has extensive hands- on knowledge of internal and external auditing as well as experience with inspections from regulatory agencies. She obtained a Master of Science in pharmaceutical sciences from the University of Cincinnati and is certified through the American Society of Quality as a certified quality auditor.
1. Provide a general overview of findings documented during ORCRA quality reviews.
2. Discuss recommendations for corrective and preventive actions.
3. Provide tips for compliance and reporting to the IRB.
Panel: Tom Asplan, RQAP-GCP; Carla Hanekamp, RN; Jean Gibson, RN, CIP; Melissa Schneider; Elva Turner, BSEd, CCRC, CCRA (moderator)
Breakout Session 4 – Sabin Center
Recruitment and Retention Toolbox Part II - case studies
“Happiness and Hardship in Headache Study Recruitment”
Janelle Allen, MS
“Yesterday’s Children: Retaining a Birth Cohort of High Risk Lead-Exposed Subjects Followed for 32 Years”
Kim Dietrich, PhD
“Creative Recruitment of Parents of Teens with Developmental Disabilities”
Amie Duncan, MD
“Removing Roadblocks to Recruitment in a Rare Disease”
Leslie Korbee, BS
Mark Schuller, MA (moderator)
Download the Recruitment and Retention Toolbox Part II presentation
Ms. Allen is a Research Coordinator within the Center for Child Behavior and Nutrition Research and Training at Cincinnati Children's. She is responsible for managing the NIH funded “Drug and Non-Drug Treatment of Pediatric Chronic Headache” and “Headstrong Intervention for Recurrent Pediatric Headache” studies and diabetes studies within her team, and also holds other responsibilities within the Pediatric Pain Program. During the past 11 years, she has completed research in developmental biology, neurophysiology / behavior, quality engineering: analytical / quality product review, molecular cardiovascular medicine, infectious diseases, and child behavior and nutrition.
Ms. Allen serves on the advisory council of Clinical Research Professionals (CRP) as the chairperson of CRP education and as a member of the CRP membership sub-committee. She is a visiting faculty member within the Department of Zoology at Miami University, and also works in community and youth / young adult development within Butler and Hamilton Counties. Ms. Allen received a Bachelor of Science from Miami University in zoology, neuroscience, French and a Master of Science from Miami University in physiology and neuroscience (zoology).
Dr. Dietrich is professor of Environmental Health and Director of the Division of Epidemiology and Biostatistics at the UC College of Medicine, Department of Environmental Health. Dr. Dietrich has also served as associate director of the Cincinnati Children’s Center for Environmental Health and Disease Prevention at Cincinnati Children's. He has served as a consultant to numerous local, state, national and international agencies and organizations concerned with the impact of environmental chemical exposures on the health and development of young children. His research has focused on the developmental effects of prenatal and early postnatal exposure to lead in infants, toddlers, school-age children, adolescents, and young adults. Dr. Dietrich is presently examining the relationship between early exposure to lead, genetic factors, and adult criminality in a long-standing prospective longitudinal birth cohort study. Among his other studies he is also examining the relationship between environmental factors that may determine pathways through puberty in girls as a risk factor for early developmental psychopathology and later pre- and post-menopausal breast cancer.
Dr. Duncan is a second year psychology postdoctoral fellow in the Division of Developmental and Behavioral Pediatrics. She is currently conducting a study on parental perspectives on the transition to adulthood in adolescents with developmental disabilities. Dr. Duncan is interested in identifying factors that impede or lead to a successful transition to adulthood and designing person-centered interventions to help adolescents with developmental disabilities, with a focus on autism spectrum disorders, achieve an optimum qualify of life in adulthood. Ms. Korbee is a medical writer / project manager for the Office for Clinical and Translational Research.
Ms. Korbee has more than more than 18 years of experience with clinical trials including project management of a multi-center international study, regulatory management of IND studies, clinical trials management of a free standing respiratory research center, study management of a skin patch safety division of a consumer products research center, and clinical and device trials management of an orthopedic research entity focused on computer navigation in total joint surgery and spine surgery research. She has also managed hospital outpatient departments and medical practices, and authored or co-authored 10 scientific publications. Ms. Korbee received her BS from the University of Cincinnati and is a registered specialist in immunology through the American Society of Clinical Pathology.
At the completion of this session, attendees will:
1. Develop a clear understanding of approaches to research trial recruitment using EDC that were the most successful and least successful.
2. Recall the challenges posed by following a high-risk, inner-city cohort from conception to early adulthood from the perspective of recruitment, tracking, retention, and maintenance of mutual trust between investigators, staff and subjects.
3. Be able to identify alternative and novel recruitment strategies for research study subjects with developmental disabilities.
4. Gain understanding of alternate strategies for clinical trial recruitment for rare disease patient populations.