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CE Credits Available for this Activity: 1
Program Overview: The purpose of this activity is to educate medical professionals on the FDA 1572 and Code of Federal Regulations as it applies to clinical research.
Target Audience: The target audience includes all healthcare professionals such as physicians, nurses, pharmacists, and allied health professionals who would like to gain a clear understanding of federal regulations and the crucial responsibilities of PIs to ensure compliant and successful clinical trials.
Release and Expiration Dates
02/16/2024 – 02/16/2027
Objectives
Identify the Code of Federal Regulations’ role in conducting clinical research.
Identify the purpose of these regulations.
Identify the Principal Investigator’s responsibilities for a clinical trial including those identified on the FDA 1572.
References
US Food and Drug Administration (FDA)
https://www.fda.gov/media/75927/download
chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.fda.gov/media/156479/download
https://datadashboard.fda.gov/ora/cd/inspections.htm
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): Jan Sullivan, MD
Speaker(s) Bio
Dr. Jan Sullivan currently serves as Professor and Vice Chair for Research in the Department of Pediatrics. Some additional roles and accomplishments include: involved in resident, fellow, and junior faculty scholarly projects; involved with several task forces and committees within the University of Louisville and Norton Children’s Hospital including Pharmacy & Therapeutics Committee and the University of Louisville Research Advisory Committee; and authored or co-authored over 60 peer-reviewed publications and 2 book chapters. She received a nursing diploma from Swedish Hospital School of Nursing, undergraduate degree from the University of Mankato, Adult Nurse Practitioner Certificate from the University of Minnesota, and her medical degree from the University of Minnesota. Dr. Sullivan completed her residency in Pediatrics at the University of Arkansas for Medical Sciences and Arkansas Children’s Hospital and a fellowship in Pediatric Critical Care and Clinical Pharmacology at Case Western Reserve University and Rainbow Babies and Children’s Hospital in Cleveland, Ohio. She is board certified in Pediatrics, Pediatric Critical Care, and Clinical Pharmacology.
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/.
