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Protocol Review vs Grant Review

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CE Credits Available for this Activity: 1

Program Overview: The purpose of this activity is to educate medical professionals about the differences between a protocol review and grant review.

Target Audience: The target audience includes all healthcare professionals such as physicians, nurses, pharmacists, and allied health professionals who would like to learn about the differences and processes between protocol review and grant review.

Release and Expiration Dates
04/16/2024 – 04/16/2027

Objectives
Identify differences between protocol versus grant review.
Apply knowledge of review process to creating rigorous and competitive clinical trial protocols.
Apply lessons learned from ECHO ISPCTN protocol chairs to future ECHO ISPCTN reviews.

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

Paul Darden, MD – Grant/Research Support: GlaxoSmithKline (GSK)

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; Rusty McCulloh, MD; Paul Darden, MD

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.

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. Paul Darden attended medical school and pediatric residency in Dallas, Texas. His fellowship was in Pediatric Epidemiology in Montreal at McGill and Montreal Children’s Hospital. His first faculty position was at the Medical University of South Carolina in Charleston, South Carolina. He joined the Department of Pediatrics at the University of Oklahoma Health Sciences Center at the end of 2008. He is a George Lynn Cross Research Professor in Pediatrics, the Chief of the Section of General and Community Pediatrics and holds the CHF James Paul Linn Chair in Pediatrics.  While in Oklahoma he has founded the Oklahoma Child Health Research Network (OCHRN) a regional practice-based research network. More recently as part of the NIH ECHO IDeA States Pediatric Clinical Trials Network (ISPCTN), he founded the Oklahoma Pediatric Clinical Trials Network. He founded and is the director of the Academic Generalist Training Program. He has had a long-standing interest in practice-based research and has established two regional practice-based research network; OCHRN and the South Carolina Pediatric Practice Research Network (SCPPRN). He has been a practitioner, coordinator, steering committee member and investigator in AAP’s Pediatric Research in Office Settings (PROS). He currently serves on the Leadership Committee of ISPCTN. Most of his research has related to the delivery of preventive care to children. This has involved numerous studies of the delivery of vaccines in practice settings. He has also studied continuity of care, dental caries, developmental screening and obesity among many issues related to primary care.

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/.