The Pediatric Research Center
Clinical Research Center Introduction and
Study Submission Guidelines
PRC Leadership
•
Anne Fitzpatrick, PhD, MSCR, APRN
Program Director of the PRC
Assistant Professor, Pediatric Pulmonology
Larry Greenbaum, MD, PhD
Associate Program Director of the PRC
Professor and Division Director, Pediatric
Nephrology
Stephanie Meisner, RN, BSN, CCRP
Clinical Research Manager of the PRC
Children’s Healthcare of Atlanta
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PRC Staff
Michelle Popler, RN, BSN
Senior Research Nurse
Jessica Heyer, RN, BSN
Research Nurse
Elizabeth Liu, EMT
Research Coordinator/Patient Care Tech.
Children’s Healthcare of Atlanta
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Where Are We?
Location:
Tower 2 Butterfly elevators 2nd Fl, inside the TDICU
Hours:
8:00 – 5:30 PM
Phone number:
404-785-0400
Facilities available for
Coordinators:
• Fax/Copy/Scan
documents in TDICU
nurses station
• Family lounge for
patients – i.e. Ice &
coffee
• Computer station in
PRC
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Directions
From admissions to the PRC
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PRC Services
Provides facilities & services for clinical research:
 4 bed outpatient unit
 4 bed inpatient unit
 Nursing resources
 Core lab
 Bio-nutrition
 Family-centered amenities
Investigational Research Pharmacist
provides Investigational Drug Services
Jim Rhodes, james.rhodes@choa.org
Research lab provides lab processing
and shipping services
Diana Worthington-White,
diana.worthington-white@choa.org
Clinical Interaction Site of the Atlanta Clinical and Translational Science Institute (ACTSI).
Funded in part by the National Institutes of Health through CTSA.
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PRC Nursing Services
– Nursing assessment
– Vital Signs and Measurements
– Phlebotomy
– IV infusions
– Roundtable Review
– Protocol Order Review
– Scheduling Assistance
– Safety Oversight
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How to get your study in the PRC
Click here for 1 page guide or visit:
http://www.pedsresearch.org/clinical-research/pediatric-researchcenter
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How to get your study in the PRC
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PRC Guidelines
Guidelines can be found here:
http://www.pedsresearch.org/clinical-research/pediatric-research-center
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Finance & Feasibility
Kris Rogers
Director of Research and Academic
Administration
Grants Administration
Pre-Award
Chuong Pham
Manager Grants Administration
grantsadmin@choa.org
Gigi Davis
Clinical Trial Feasibility Coordinator
Lori Brown
Sr Sponsored Res. Admin
Deanna West
Sponsored Research Admin
Shareena Pettway
Sponsored Research Coordinator
Office of Sponsored Programs
Shanta Laurie
Manager Office of Sponsored
Programs
OSP@choa.org
Eme Anderson
SR OSP Analyst
Qiana Ayana
SR OSP Analyst
Office of Grants Accounting
Post-Award
Shakeeta Nicholson
Manager Office of Grants Accounting
officeofgrantsaccounting@choa.org
Rodrigus Molden
Senior Grants Financial Coordinator
Dietre May
Grants Financial Coordinator
Kesia Hudson
Grants Financial Coordinator
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Finance Breakdown
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Pre-Award Functions
Provide institutional
information and assist
with form preparation
Feasibility Analysis
Review and edit
proposals
Facilitate and manage
internal routing and
review
Negotiate and execute
contracts and
subcontracts
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Post-Award Functions
Budget Management
Grant Invoicing
Monitor Deliverables
Electronics Financial
Drawdowns
Coordination
Grant Closeout
Billing Trackers
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CHOA Routing Checklist
Complete Intent to Submit Form:
http://www.pedsresearch.org/clinical-research/resources/RAS
Email study protocol to :
prc@choa.org
Stepanie.meisner@choa.org
Send DAF and budget requests to ALL CHOA ancillary
services including the PRC
DAF & Budget Forms:
Click here for Forms
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ACTSI Submission
ACTSI submission info.:
http://www.atlantactsi.org/areas/crn/protocol_submission/index.h
tml
Submitting to What?
• The Scientific Advisory Committee (SAC)
• Meets once/month
• Reviews all protocols submitted to ACTSI for scientific soundness
and execution
• Members include investigators (MD’s & PhD’s), statisticians,
nutritionists and nurses.
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ACTSI Submission
Submit below items to: cnetwor@emory.edu
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1. ACTSI Form
2. IRB documents
(can be pending)
3. PRC Draft Orders
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SAC Meeting Schedule: 2014
• Completed submissions head
to SAC for review
• Should be submitted 3
weeks prior to scheduled
SAC meeting
• Check the SAC Meeting
Schedule
• 2014 Schedule here
Committee
Meeting Date
Submission
Deadline
SAC 2
January 14,
2014 (Tue)
December 24,
2013
SAC 3
February 13,
2014 (Thu)
January 23,
2014
SAC 1
March 13,
2014 (Thu)
February 20,
2014
SAC 2
April 8, 2014
(Tue)
March 18, 2014
SAC 3
May 8, 2014
(Thu)
April 17, 2014
SAC 1
June 12, 2014 May 22, 2014
(Thu)
SAC 2
July 8, 2014
(Tue)
June 17, 2014
SAC 3
August 14,
2014 (Thu)
July 24, 2014
SAC 1
September 11, August 21, 2014
2014 (Thu)
SAC 2
October 14,
2014 (Tue)
SAC 3
November 13, October 23,
2014
2014 (Thu)
SAC 1
December 11,
2014 (Thu)
September 23,
2014
November 20,
2014
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PRC Checklist
• Submit Order sets to: PRC@choa.org using our
Order Set Template
• PRC staff verifies orders with study protocol
• Coordinator needs to verify returned edited
orders
• Finalize orders
Any changes should be sent and verified with
PRC prior to use
• Once approved by SAC, schedule roundtable
meeting with PRC team
• Orders will be reviewed at roundtable
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PRC Checklist
• Provide PRC with ACTSI SAC approval letter
• Organize In-service needs:
Research lab, pharmacy, EKG, ECHO, etc.
• Order necessary equipment and supplies
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Obtaining CR-Assist Access
CR-Assist: ACTSI research appointment hub
Info: http://www.atlantactsi.org/areas/crn/crassist/index.html
 Contact Khushbu Amin for access and send completed study
form to Kamin5@emory.edu
CR-Assist Access Form
 Contact Audrey Kelly at Audrey.kelly@emoryhealthcare.org
for CR-Assist training & study visit set up after
Khushbu’s approval
Children’s Healthcare of Atlanta
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Obtaining CR-Assist Access
CR-Assist Study Setup Form
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Other ACTSI Research Resources
More Info on Services offered:
http://www.atlantactsi.org/areas/crn/services%20available.html
http://www.atlantactsi.org/areas/crn/services/index.html
• Comprehensive biostatistical and epidemiological support
(BERD Program)
• Biomedical Informatics Program (BIP)
• Community engagement expertise (CERP)
• Pediatrics Expertise
• Research Technology Resources
• Core Facilities
• National Recruitment Assistance
• REDCap
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PRC Scheduling Steps
Once study built in CR-Assist:
• Enter appointment request through CR-Assist
• PRC will approve and schedule
PRC staff pre-registers patient in EPIC
• Patient registers with registration in CHOA lobby on 1st visit
• Patient must be re-registered after 1 year
Subject comes to PRC for consent and treatment
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Not a CHOA Employee?
How to Get Credentialed:
 Contact CHOA Credentialing Services at below numbers for
appropriate application packet (non-clinical, clinical, chart review, etc.)
 Complete top section of Credentialing Checklist
 Scan form to CHOA Clinical Research Credentialing Rep:
Saadia Khizer saadia.khizer@choa.org (404-785-9893)
CHOA Credentialing Contacts:
Name
Title
CHOA Ext.
Provider
Last Name
Kuklinski, Lisa
Manager
404-785-7485
N/A
Lowry, Susan
Supervisor
404-785-7487
N/A
Morris,
Enriquita
Credentialing
Coordinator
404-785-7492
A, B, V, X, Y, Z
Brzezinski,
Vickie
Credentialing
Coordinator
404-785-6798
J, L, T, W
Guda, Susan
Credentialing
Coordinator
404-785-2198
M, N, O, P
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For Patient Chart Access/Patient Contact:
You will need:
• Background Consent Form
•
Complete Drug Screen
•
Immunization records with Employee Health
*Flu shot and TB test will be required if not already obtained*
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For Clinical Credentialing:
You will need:
• Contact Susan Guda in Credentialing Services at (404) 7852198
• Complete “Credentialing and Scope of Practice” form and
application packet obtained from Credentialing Services
Children’s Healthcare of Atlanta
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End of Route Steps
Agreements and Sub-Agreements
Emory and CHOA
• Contract site determined by investigator (Emory
Investigator=Emory PRIME Award)
• Sub-contract site = Performance site
– Where the research activities are done (CHOA for PRC)
• MUST be completed PRIOR to subject being seen in PRC
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Post Approval Processes
Required updates and Renewals
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Protocol and Agreement Amendments
IRB modification, renewal and event reporting – CHOA/Emory
OCR communications
Grants Management – renewals, reporting, on-going routing
Sponsor / Monitor communication, monitoring visits, queries
DSMB reporting
Billing
Patient care billing
• Coordinators must complete billing trackers
Facility and Professional Services fees
• Must be included on billing trackers
• Subject must be PRE-registered for bill-hold before EVERY
visit: http://www.choa.org/Pediatric-Research/ResearchVisit-Pre-Registration
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Study Completion
Publications
• MUST CITE ACTSI support in publications:
http://www.atlantactsi.org/about/citation.html
Citing ACTSI:
"Supported by the National Center for Advancing Translational Sciences of the National Institutes of Health
under Award Number UL1TR000454. The content is solely the responsibility of the authors and does not
necessarily represent the official views of the National Institutes of Health." KL2 Scholars should also list KL2
TR000455 and TL1 Trainees should also list TL1 TR000456.
• Share with PRC when published
• Publication of findings in peer reviewed journal
• Goal to share knowledge and improve care
• Must register study with http://clinicaltrials.gov/
• (NIH service, public access, ICMJE)
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Study Completion
After the study
• Notify all services that study has ended, including PRC
• IRB Completion
• Records retention – IRB / finance 2 years , Subject records – 10
years /determined by sponsor
• Billing and grant completion
• Sponsor Agreement Termination
• Sub-Agreement termination
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Coordinator Reminders
Remind patients of NPO status
Pre-Register pt. on choa.org/research for bill-hold
Complete pre-appointment patient trackers
Complete patient trackers immediately after appt.
Schedule patient in CR-Assist at least 2-3 weeks prior to
appointment
• If necessary, notify ancillary services (pharmacy, EKG, ECHO,
etc.) of patient schedule changes
• Bring SIGNED Orders to study visit
• Adhere to PRC Guidelines
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PRC Contacts
Important Emails:
PRC@choa.org
Manager: Stephanie.Meisner@choa.org
Nurses:
Michelle.Popler@choa.org
Jessica.Heyer@choa.org
Tech:
Elizabeth.Liu@choa.org
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