The Pediatric Research Center Clinical Research Center Introduction and Study Submission Guidelines.
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The Pediatric Research Center Clinical Research Center Introduction and Study Submission Guidelines
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Transcript of The Pediatric Research Center Clinical Research Center Introduction and Study Submission Guidelines.
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, APRNProgram Director of the PRCAssistant Professor, Pediatric Pulmonology
Larry Greenbaum, MD, PhDAssociate Program Director of the PRCProfessor and Division Director, Pediatric Nephrology
Stephanie Meisner, RN, BSN, CCRPClinical Research Manager of the PRC
Children’s Healthcare of Atlanta
PRC Staff
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Michelle Popler, RN, BSNSenior Research Nurse
Jessica Heyer, RN, BSNResearch Nurse
Elizabeth Liu, EMTResearch 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 ServicesJim Rhodes, [email protected]
Research lab provides lab processing and shipping servicesDiana 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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PRC
1PAGE
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 NicholsonManager Office of Grants [email protected]
Office of Grants AccountingPost-Award
Rodrigus MoldenSenior Grants Financial Coordinator
Dietre MayGrants Financial Coordinator
Kesia HudsonGrants Financial Coordinator
Chuong PhamManager Grants Administration
Shanta LaurieManager Office of Sponsored
Grants AdministrationPre-Award
Office of Sponsored Programs
Eme AndersonSR OSP Analyst
Qiana AyanaSR OSP Analyst
Gigi DavisClinical Trial Feasibility Coordinator
Lori BrownSr Sponsored Res. Admin
Deanna WestSponsored Research Admin
Shareena PettwaySponsored Research Coordinator
Kris RogersDirector 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 :[email protected]@choa.org
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
EXAMPLE
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 hubInfo: http://www.atlantactsi.org/areas/crn/cr-assist/index.html
Contact Khushbu Amin for access and send completed study form to [email protected] 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
EXAMPLE
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 (BE
RD Program)• Biomedical Informatics Program (BIP)• Community engagement expertise (CERP)• Pediatrics Expertise• Research Technology Resources• Core Facilities• National Recruitment Assistance• REDCap
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 StepsAgreements 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 ProcessesRequired 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 CompletionPublications
• 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]
