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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 during a research study monitoring visit.
Target Audience: The target audience includes all healthcare professionals such as physicians, nurses, pharmacists, and allied health professionals who would like to to master the preparation and execution of effective monitoring visits, ensuring smooth and compliant clinical trial operations.
Release and Expiration Dates
04/16/2024 – 04/16/2027
Objectives
List 3 components of a monitoring visit.
List 3 tasks to prepare for a monitoring visit.
Describe the roles of team members during a monitoring visit.
References
https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
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
Panelist: Jan Sullivan, MD; Rob Akins, PhD; Maria Barber, DO; Kristina Foster, APRN; Kripa Patel, MPH
Panel 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.
Robert E. Akins, Jr., PhD, FAACPDM, FAHA is a Principal Scientist, Director of the Center for Pediatric Clinical Research and Development, and Head of Tissue Engineering and Regenerative Medicine Research at the Nemours Children’s Hospital in Delaware. He holds multiple leadership roles in research, mentoring, and professional development programs in the state, and he is a full professor affiliated with the departments of Materials Science & Engineering, Biomedical Engineering, and Biological Sciences at the University of Delaware. He joined Nemours in 1992. Dr. Akins received both his bachelor’s and doctoral degrees from the University of Pennsylvania. He is an inaugural fellow of the American Heart Association and a Fellow of the American Academy for Cerebral Palsy and Developmental Medicine.
Maria Barber, DO, specializes in the health of newborns, especially those who are born ill or prematurely at Avera Medical Group Neonatology in Sioux Falls, SD. Neonatology is a hospital-based specialty found in neonatal intensive care units. Before coming to Avera, Dr. Barber enjoyed the opportunity to study necrotizing enterocolitis (NEC), a condition which affects the entire gastrointestinal tract of premature infants.
Kristina Foster earned her Bachelor of Science degree in Nursing from Olivet Nazarene University and her Master of Science in Nursing from Northern Illinois University. Her nursing experience is as broad geographically as it is clinically. She has held positions from the bedside to management, oncology to wound/ostomy and education, and from the University of Chicago in Illinois to Children’s Mercy Kansas City, and Lucile Packard Children’s Hospital at Stanford in California. She has been at KUMC in pediatric research for the past three years and enjoys the opportunity to have a hybrid of working-from-home time with working in the office.
Kripa is a Clinical Site Manager at the DCOC. She coordinates and oversees all clinical site management activities to include management of protocol conduct, data collection and review, and coordination of all study related communication. Kripa assists with the overall successful conduct of assigned clinical trials, including preparation of study material section and training. She also takes a lead on study start-up activities to include clinical site activation. As part of clinical site management, Kripa provides expertise in developing study Manual of Procedures, building relationships with sites, and resolving site issues and queries. Kripa’s prior roles include practicing Dentistry at Bapuju Dental Hospital in India; serving in several Program Manager roles and being a published author.
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/.
