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CE Credits Available for this Activity: 1
Program Overview: The purpose of this activity is to educate medical professionals on leading 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 enhance their expertise in managing FDA trials and to ensure compliance, efficiency, and successful outcomes.
Release and Expiration Dates
04/16/2024 – 04/16/2027
Objectives
Review good documentation practice (GDP) to ensure ALCOA-C compliance.
Review preparing for and responding to FDA audits.
Discuss differing requirements for FDA trials and past ISPTCN interventional clinical trials.
Review research team roles and staff requirements for FDA trials and discuss needed/useful training and certifications.
Review research pharmacists’ roles in FDA trials and how to establish organizational collaborations with them.
Discuss typical FDA study-related time and effort allotments for PIs, including oversight and study responsibilities.
Discuss a brief case study of a PI’s first FDA trial, i.e., the subject of the trial, the timeline, and the results.
References
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application
https://www.fda.gov/media/78830/download
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
Panelists: Jan Sullivan, MD; Daniel Hsia, MD; Rusty McCulloh, MD; Ashley DesChamp, MD
Panel Bio
Dr. Jan Sullivan joined the Department of Pediatrics at the University of Louisville in July of 1995. She is a Professor of Pediatrics in the Divisions of Pediatric Critical Care and Clinical & Translational Research. She graduated from the University of Minnesota School of Medicine (1988), completed her Pediatric residency at Arkansas Children’s Hospital in (1991), and a fellowship in Pediatric Critical Care and Clinical Pharmacology at Rainbow Babies and Children’s Hospital in Cleveland, Ohio (1995). She is board certified in Pediatrics, Pediatric Critical Care, and Clinical Pharmacology. Currently she is the Vice Chair for Research in the Department of Pediatrics. She also is an investigator for the NIH funded IDeA State Grant which is primarily dedicated to reaching rural and underserved populations for clinical trials in 5 specific focus areas related to environmental influences on child health. She has over 30 years of research experience which has primarily focused on clinical pharmacology trials for pediatric patients. Her current focus is faculty education and mentoring in clinical research to train the next generation of clinician scientists.
Dr. Daniel Hsia is a Louisiana native and a graduate of Jesuit High School in New Orleans. In 2004 he completed the 6 year Accelerated Biomedical Program at Rensselaer Polytechnic Institute in Troy, NY and Albany Medical College in Albany, NY. During this time he received his Bachelor of Science degree in Biology as well as his Doctor of Medicine. He went on to complete a combined Internal Medicine and Pediatrics residency at LSU Health Sciences Center in New Orleans in 2008 and served as a Chief Resident during his final year of training. He then moved to Baylor College of Medicine and Texas Children’s Hospital where he completed a combined Adult and Pediatric Endocrinology fellowship in 2012.
Dr. McCulloh is an Associate Professor of Pediatrics and Division Chief for Pediatric Hospital Medicine at the University of Nebraska Medical Center (UNMC) and Children’s Hospital and Medical Center in Omaha. He has been principal investigator of the Nebraska ISPCTN site since 2018, after having previously served in this role at the Kansas site. He has been an active member of the ISPCTN, previously acting as Chair of the Capacity-building and Professional Development Workgroup, and currently serving on the Leadership Committee. His research interests focus on health outcomes and implementation science projects that translate new evidence for diagnosis and management of children with acute illness into clinical practice. Outside of the ISPCTN, Dr. McCulloh has led multi-site dissemination and implementation projects that focus on infants hospitalized with suspected sepsis, asthma exacerbation, bronchiolitis, and community-acquired pneumonia.
Dr. Deschamp is a new addition to the NPCTU team in her role as a junior faculty co-investigator. She is an Assistant Professor of Pediatric Pulmonology at University of Nebraska Medical Center College of Medicine and a member of the Child Health Research Institute. She is currently a site principal investigator for the Cystic Fibrosis Therapeutics Development Center, a part of the Cystic Fibrosis Foundation’s research network. Her research interests include identifying the role of the gut and respiratory microbiomes on lung growth and development and identifying novel nutritional interventions to reduce dysbiosis and maximize healthy lung development in children with cystic fibrosis.
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/.
