CE Credits Available for this Activity: .75
Release and Expiration Dates
11/7/2023 – 11/7/2026
Knowledge Gap: The purpose of this activity is to educate healthcare providers with the most up-to-date information on properly conducting FDA clinical trials.
Target Audience: The target audience includes all healthcare professionals such as physicians, nurses, pharmacists, and allied health professionals who would like to learn about conducting FDA clinical trials.
Program Overview: The purpose of this activity is to educate medical professionals on root cause analysis in quality management.
Objectives
Explain the regulations and guidelines ECHO ISPCTN will need to follow in FDA trials that differ from prior studies.
Identify the roles and responsibilities of principal investigators and other research team members in FDA trials.
References
Food & Drug Administration (FDA)
ECHO IDeA States Pediatric Clinical Trial Network (ISPCTN)
US Department of Health and Human Services (HHS)
Financial Disclosure Statement
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): Jessica Snowden, MD, MS, MHPTT; Amy Doville, MBA, CCRP
Speaker(s) Bio
Dr. Jessica Snowden is the Vice Dean for Research at the University of Arkansas for Medical Sciences (UAMS) College of Medicine as well as 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). Dr. Snowden is responsible for directing clinical operations for trial implementation and professional development and provides strategic leadership for the DCOC to include overseeing clinical trial activities for all ECHO ISPCTN trials.
Amy Doville serves as the Program Director for the ECHO IDeA States Pediatric Network (ISPCTN) Data Coordinating Operations Center (DCOC) directing DCOC staff who manage the operational aspects of trials from start-up to final reporting. She works closely with the grant principal investigators, the NIH Program Office, and the DCOC Quality Program to ensure quality deliverables and adherence to protocol requirements, study operational plans, timelines, ICH GCP, and applicable SOPs. Amy has over 30 years of research experience including drugs and devices, consumer testing, and basic science.
Instructions to Obtain Credit
(1) Launch the activity
(2) View the module
(3) Take 1 post-test at the end
(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 .75 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 .75 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 .75 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 .75 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
Email: cmeconf@uams.edu
Phone: 501-661-7962
DCOC Contact Information
Catrice Banks-Johnson
Email: crbanksjohnson@uams.edu
DeAnn Hubberd
Email: DEHubberd@uams.edu
