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CE Credits Available for this Activity: 1
Program Overview: The purpose of this activity is to educate medical professionals on what to expect when conducting FDA clinical trials.
Target Audience: The target audience includes all healthcare professionals such as physicians, nurses, pharmacists, and allied health professionals who are involved in FDA clinical trials.
05/15/2024 – 05/15/2027
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)
Faculty Disclosure
The following planners, speakers, moderators, peer reviewers, and/or panelists of this CE activity have financial relationships with ineligible companies to disclose:
Jessica Snowden, MD – Consultant: Pfizer
All financial relationships have been mitigated.
No other planners, speakers, and/or peer reviewers of this CME activity have relevant financial relationships with ineligible companies to disclose.
The compliance reviewer, Courtney Bryant, Sara Hale, or Brandie Jones, has no relevant financial relationships with ineligible companies to disclose.
Planners: Jessica Snowden, MD; Jeannette Lee, PhD; Lora Lawrence, RN; Catrice Banks-Johnson, MPA; DeAnn Hubberd, MA
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).
Instructions to Obtain Credit
(1) Launch the activity
(2) View the entire module online
(3) Complete the post-test
(must pass the post-test with a score of 80% to receive credit)
You may retake the post-test if you do not receive a passing score.
(4) Complete Evaluation and Print certificate
Joint Accreditation Statement
In support of improving patient care, this activity has been planned and implemented by the University of Arkansas for Medical Sciences. University of Arkansas for Medical Sciences is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
Credit Designation Statements
AMA Credit Designation Statement
The University of Arkansas for Medical Sciences designates this enduring material activity for a maximum of 1 AMA PRA Category 1 CreditsTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
ACPE Credit Designation Statement
These knowledge-based activities will provide pharmacists with up to 1.0 contact hour or 1 CEU. CE credit information, based on participation and completion of the program evaluation, will be provided to NABP within 60 days after the activity completion.
ANCC Credit Designation Statement
The University of Arkansas for Medical Sciences designates this enduring material activity for a maximum of 1 ANCC contact hours. Nursing contact hours will be awarded for successful completion of program components based upon documented attendance and completion of evaluation materials.
AAPA Credit Designation Statement
The University of Arkansas for Medical Sciences has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. This activity is designated for 1 AAPA Category 1 CME credits. PAs should only claim credit commensurate with the extent of their participation.
Disclosure Policy Statement
It is the policy of the University of Arkansas for Medical Sciences (UAMS), Office of Continuing Education (OCE) to ensure balance, independence, objectivity, and scientific rigor in all directly or jointly provided educational activities. All individuals who are in a position to control the content of the educational activity (course/activity directors, planning committee members, staff, teachers, or authors of CE) must disclose all relevant financial relationships they have with any commercial interest(s) as well as the nature of the relationship. The ACCME describes relevant financial relationships as those in any amount occurring within the past 24 months that create a conflict of interest. Individuals who refuse to disclose will be disqualified from participation in the development, management, presentation, or evaluation of the CE activity.
UAMS Office of Continuing Education (OCE) Contact Information
4301 W Markham Street #525
Little Rock, AR 72205
Email: cmeconf@uams.edu
Phone: 501-661-7962 Fax: 501-661-7968
DCOC Contact Information
Catrice Banks-Johnson
Email: crbanksjohnson@uams.edu
DeAnn Hubberd
Email: DEHubberd@uams.edu
You can download an official transcript from your CloudCME profile (https://uams.cloud-cme.com/default.aspx) or you can request a copy of your transcript at https://ce.uams.edu/transcript-request-2/.
