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The Pediatric Research Center
Clinical Research Center Introduction and
Study Submission Guidelines
Children’s Healthcare of Atlanta
PRC Leadership
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• 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
PRC Staff
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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
Where Are We?
Location:
Tower 2 Butterfly elevators 2nd Fl, inside the TDICU
Hours:
8:00 – 5:30 PM
Phone number:
404-785-0400
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Facilities available for
Coordinators:
• Fax/Copy/Scan
documents in TDICU
nurses station
• Family lounge for
patients – i.e. Ice &
coffee
• Computer station in
PRC
Children’s Healthcare of Atlanta
Directions From admissions to the PRC
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Children’s Healthcare of Atlanta
PRC Services
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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, [email protected]
Research lab provides lab processing and shipping services Diana Worthington-White, [email protected]
Clinical Interaction Site of the Atlanta Clinical and Translational Science Institute (ACTSI).
Funded in part by the National Institutes of Health through CTSA.
Children’s Healthcare of Atlanta
PRC Nursing Services
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– Nursing assessment
– Vital Signs and Measurements
– Phlebotomy
– IV infusions
– Roundtable Review
– Protocol Order Review
– Scheduling Assistance
– Safety Oversight
Children’s Healthcare of Atlanta
How to get your study in the PRC
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Click here for 1 page guide or visit:
http://www.pedsresearch.org/clinical-research/pediatric-research-
center
Children’s Healthcare of Atlanta
How to get your study in the PRC
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Children’s Healthcare of Atlanta
PRC Guidelines
Guidelines can be found here:
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http://www.pedsresearch.org/clinical-research/pediatric-research-center
Children’s Healthcare of Atlanta
Finance & Feasibility
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Shakeeta Nicholson Manager Office of Grants Accounting [email protected]
Office of Grants Accounting Post-Award
Rodrigus Molden Senior Grants Financial Coordinator
Dietre May Grants Financial Coordinator
Kesia Hudson Grants Financial Coordinator
Chuong Pham Manager Grants Administration
Shanta Laurie
Manager Office of Sponsored Programs
Grants Administration Pre-Award
Office of Sponsored Programs
Eme Anderson SR OSP Analyst
Qiana Ayana SR OSP Analyst
Gigi Davis Clinical Trial Feasibility Coordinator
Lori Brown Sr Sponsored Res. Admin
Deanna West Sponsored Research Admin
Shareena Pettway Sponsored Research Coordinator
Kris Rogers Director of Research and Academic
Administration
Children’s Healthcare of Atlanta
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
Post-Award Functions • Budget Management • Grant Invoicing • Monitor Deliverables • Electronics Financial
Drawdowns Coordination
• Grant Closeout • Billing Trackers
Children’s Healthcare of Atlanta
Complete Intent to Submit Form:
http://www.pedsresearch.org/clinical-research/resources/RAS
Email study protocol to :
Send DAF and budget requests to ALL CHOA ancillary services including the PRC
DAF & Budget Forms:
Click here for Forms
CHOA Routing Checklist
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Children’s Healthcare of Atlanta
ACTSI Submission
ACTSI submission info.: http://www.atlantactsi.org/areas/crn/protocol_submission/index.html
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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Children’s Healthcare of Atlanta
ACTSI Submission
Submit below items to: [email protected]
1. ACTSI Form
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2. IRB documents (can be pending) 3. PRC Draft Orders
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Children’s Healthcare of Atlanta
SAC Meeting Schedule: 2014
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 (Thu)
May 22, 2014
SAC 2 July 8, 2014 (Tue)
June 17, 2014
SAC 3 August 14, 2014 (Thu)
July 24, 2014
SAC 1 September 11, 2014 (Thu)
August 21, 2014
SAC 2 October 14, 2014 (Tue)
September 23, 2014
SAC 3 November 13, 2014 (Thu)
October 23, 2014
SAC 1 December 11, 2014 (Thu)
November 20, 2014
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• 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
Children’s Healthcare of Atlanta
PRC Checklist
• Submit Order sets to: [email protected] using our
Order Set Template
• Once approved by SAC, schedule roundtable meeting with PRC team
• Orders will be reviewed at roundtable
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• 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
Children’s Healthcare of Atlanta
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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Children’s Healthcare of Atlanta
Obtaining CR-Assist Access
CR-Assist: ACTSI research appointment hub
Info: http://www.atlantactsi.org/areas/crn/cr-assist/index.html
Contact Khushbu Amin for access and send completed study form to [email protected]
CR-Assist Access Form
Contact Audrey Kelly at [email protected] for CR-Assist training & study visit set up after Khushbu’s approval
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Children’s Healthcare of Atlanta
Obtaining CR-Assist Access
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CR-Assist Study Setup Form
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Children’s Healthcare of Atlanta
Other ACTSI Research Resources
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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
• Research Match
• REDCap
• Pilot Grants and Education Programs
Children’s Healthcare of Atlanta
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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Children’s Healthcare of Atlanta
Not a CHOA Employee?
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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 [email protected] (404-785-9893)
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
CHOA Credentialing Contacts:
Children’s Healthcare of Atlanta
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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Children’s Healthcare of Atlanta
For Clinical Credentialing:
You will need:
• Contact Susan Guda in Credentialing Services at (404) 785-2198
• Complete “Credentialing and Scope of Practice” form and application packet obtained from Credentialing Services
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Children’s Healthcare of Atlanta
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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Children’s Healthcare of Atlanta
Post Approval Processes Required updates and Renewals
• 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/Research-Visit-Pre-Registration
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Children’s Healthcare of Atlanta
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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Children’s Healthcare of Atlanta
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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Children’s Healthcare of Atlanta
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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Children’s Healthcare of Atlanta
PRC Contacts
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Important Emails:
Manager: [email protected]
Nurses: [email protected]
Tech: [email protected]