Objectives
Review research team roles and staff requirements for FDA trials, and discuss needed/useful training and certifications.
Discuss preparing your site team for an FDA trial.
Review preparing for and responding to FDA audits.
Review good documentation practice (GDP) to ensure ALCOA-C compliance.
References
US Food & Drug Administration (FDA)
National Institute of Health (NIH)
Speaker(s): Jackie Boyd, RN, BSN; Laurie Chassereau, RN, BSN; Kathy Edwards, RN, BSN; Christa Friedrich; Kathy Hummel
Speaker(s) Bio
Jackie Boyd RN, BSN, CCRC: Jackie received her Bachelor of Science in Nursing from Indiana University Southeast in 2006. She started her nursing career in Mother Baby but moved to Pediatrics as a Float Nurse and then the pediatric Emergency Department in 2007. In 2014, she joined the Pediatric Clinical Research Unit learning a new side of nursing and the healthcare field. In 2017, she obtained her Certificate in Healthcare Professions Education from the University of Louisville and became a Certified Clinical Research Coordinator in 2019. Jackie has been a part of the ISPCTN since the beginning and has been the project manager for the Kentucky ECHO Pediatric IDeA Research Center.
Laurie Chassereau, RN, BSN, CCRC: Laurie Chassereau is a Research Nurse with the Office of Clinical Trials at the University of Vermont, and a Certified Clinical Research Coordinator. She has dedicated the last 20 years of her nursing practice to clinical research. Laurie has supported the coordination of adult and pediatric oncology research at the University of Vermont Medical Center, and most recently research studies focusing on children’s health with the Vermont site of the ISPCTN. She received her ADN from Trocaire College in Buffalo, NY, and her BSN degree from the University of Vermont.
Kathy Edwards, BSN, RN, CCRP, CCRA: Kathy serves as the project lead over the ACT NOW clinical trials, Eat Sleep Console (ESC) and the Weaning Study, working closely with the trial sponsors; Neonatal Research Network (NRN), Duke Clinical Research Institute (DCRI), and RTI. She provides updates in local and global meetings for both ACT NOW trials providing coordination and leadership to the ESC and Weaning IRB/cIRB team meetings for the DCOC. Kathy serves as the project lead for the PhITT study. In addition to her role as project lead on ECHO ISPCTN studies, Kathy coordinates and leads the DCOC Associate Director’s monthly team meetings and serves on the ISPCTN Portal Team where she is responsible for uploading and maintaining all site-specific documents for assigned studies.
Christa Friedrich, MS, ACRP-CP: Christa Friedrich is the Clinical Research Manager at the Center for Pediatric and Community Research in Sioux Falls, SD. She has a BS in Human Development and a MS in Education and Human Sciences with an emphasis in Child and Family Studies, both from South Dakota State University. Friedrich has been involved in various capacities of children’s health research for over 13 years with experience in both community based and clinical trial research. Currently, Friedrich manages the clinical research team and leads operations within the research Center.
Kathy Hummel, RNP, MSN, CCRP: Kathy has been an APRN at Arkansas Children’s Hospital for 15 years. She worked in the pediatric clinical trials unit on both NIH and FDA studies for 13 years. She currently serves as the clinical site manager for the Recover Initiative overseeing 14 clinical sites across the US. Kathy is a Certified Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA).
DCOC Contact Information
Catrice Banks-Johnson
Email: crbanksjohnson@uams.edu
DeAnn Hubberd
Email: DEHubberd@uams.edu
