the pediatric research center - georgia ctsa...shareena pettway sponsored research coordinator kris...

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


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.


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


Directions From admissions to the PRC

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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.

mailto:[email protected]:[email protected]:[email protected]:[email protected]


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


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

http://pedsresearch.org/_files/How do I get my study into PRC_1 page3.14.2014.pdfhttp://pedsresearch.org/_files/How do I get my study into PRC_1 page3.14.2014.pdfhttp://www.pedsresearch.org/clinical-research/pediatric-research-centerhttp://www.pedsresearch.org/clinical-research/pediatric-research-centerhttp://www.pedsresearch.org/clinical-research/pediatric-research-centerhttp://www.pedsresearch.org/clinical-research/pediatric-research-centerhttp://www.pedsresearch.org/clinical-research/pediatric-research-centerhttp://www.pedsresearch.org/clinical-research/pediatric-research-centerhttp://www.pedsresearch.org/clinical-research/pediatric-research-centerhttp://www.pedsresearch.org/clinical-research/pediatric-research-center


How to get your study in the PRC

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PRC Guidelines

Guidelines can be found here:

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http://www.pedsresearch.org/clinical-research/pediatric-research-center

http://www.pedsresearch.org/clinical-research/pediatric-research-centerhttp://www.pedsresearch.org/clinical-research/pediatric-research-centerhttp://www.pedsresearch.org/clinical-research/pediatric-research-centerhttp://www.pedsresearch.org/clinical-research/pediatric-research-centerhttp://www.pedsresearch.org/clinical-research/pediatric-research-centerhttp://www.pedsresearch.org/clinical-research/pediatric-research-centerhttp://www.pedsresearch.org/clinical-research/pediatric-research-center


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

[email protected]

Shanta Laurie

Manager Office of Sponsored Programs

[email protected]

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

mailto:[email protected]:[email protected]:[email protected]


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


Complete Intent to Submit Form:

http://www.pedsresearch.org/clinical-research/resources/RAS

Email study protocol to :

[email protected]

[email protected]

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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http://www.pedsresearch.org/clinical-research/resources/RAShttp://www.pedsresearch.org/clinical-research/resources/RAShttp://www.pedsresearch.org/clinical-research/resources/RAShttp://www.pedsresearch.org/clinical-research/resources/RASmailto:[email protected]:[email protected]://pedsresearch.org/clinical-research/Forms


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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http://www.atlantactsi.org/areas/crn/protocol_submission/index.htmlhttp://www.atlantactsi.org/areas/crn/protocol_submission/index.htmlhttp://www.atlantactsi.org/areas/crn/protocol_submission/index.htmlhttp://www.atlantactsi.org/areas/crn/protocol_submission/index.html


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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mailto:[email protected]://www.atlantactsi.org/areas/crn/documents/CRN application form


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

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&docid=7b_yLtN9GE7VoM&tbnid=MpTHqUg376BTqM:&ved=0CAUQjRw&url=http://www.eyecenter.emory.edu/research.htm&ei=Y4n_U8zjHMWeggS56YG4Dw&bvm=bv.74035653,d.eXY&psig=AFQjCNFe8p0Ga7dm8a8qPCsa4i_BiRk-cg&ust=1409342177567159http://www.atlantactsi.org/areas/crn/protocol_submission/index.htmlhttp://www.atlantactsi.org/areas/crn/protocol_submission/index.html


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

mailto:[email protected]://www.atlantactsi.org/areas/crn/protocol_submission/forms.htmlhttp://www.atlantactsi.org/areas/crn/protocol_submission/forms.html


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/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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http://www.atlantactsi.org/areas/crn/cr-assist/index.htmlhttp://www.atlantactsi.org/areas/crn/cr-assist/index.htmlhttp://www.atlantactsi.org/areas/crn/cr-assist/index.htmlhttp://www.atlantactsi.org/areas/crn/cr-assist/index.htmlmailto:[email protected]://www.atlantactsi.org/areas/crn/cr-assist/index.htmlhttp://www.atlantactsi.org/areas/crn/cr-assist/index.htmlhttp://www.atlantactsi.org/areas/crn/cr-assist/index.htmlmailto:[email protected]


Obtaining CR-Assist Access

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CR-Assist Study Setup Form

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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

http://www.atlantactsi.org/news/2014/redcap_training.htmlhttp://www.atlantactsi.org/news/2014/redcap_training.htmlhttp://www.atlantactsi.org/news/2014/redcap_training.htmlhttp://www.atlantactsi.org/news/2014/redcap_training.htmlhttp://www.atlantactsi.org/news/2014/redcap_training.htmlhttp://www.atlantactsi.org/news/2014/redcap_training.htmlhttp://www.atlantactsi.org/news/2014/redcap_training.htmlhttp://www.atlantactsi.org/news/2014/redcap_training.htmlhttp://www.atlantactsi.org/news/2014/redcap_training.htmlhttp://www.actsi.org/areas/berd/studio.htmlhttp://www.actsi.org/areas/berd/studio.htmlhttp://www.actsi.org/areas/berd/studio.htmlhttp://www.actsi.org/areas/berd/studio.htmlhttp://www.atlantactsi.org/areas/cerp/index.htmlhttp://www.atlantactsi.org/areas/pediatrics/index.htmlhttp://www.atlantactsi.org/areas/research_tech/documents/Research Tech Flyer.pdfhttp://www.atlantactsi.org/areas/research_tech/documents/Research Tech Flyer.pdfhttp://www.atlantactsi.org/areas/crn/services/REDCap.htmlhttp://www.atlantactsi.org/news/2014/redcap_training.htmlhttp://www.atlantactsi.org/news/2014/redcap_training.htmlhttp://www.atlantactsi.org/news/2014/redcap_training.htmlhttp://www.atlantactsi.org/news/2014/redcap_training.html


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?

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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:

http://www.choa.org/health-professionals/clinical-research/~/media/CHOA/Documents/Health-Professionals/Clinical-Research/Credentialing-Checklist-11-13.docmailto:[email protected]


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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http://www.choa.org/health-professionals/clinical-research/~/media/CHOA/Documents/Health-Professionals/Clinical-Research/Updated-Background-Consent-form.pdf


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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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

• 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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http://www.choa.org/Pediatric-Research/Research-Visit-Pre-Registrationhttp://www.choa.org/Pediatric-Research/Research-Visit-Pre-Registrationhttp://www.choa.org/Pediatric-Research/Research-Visit-Pre-Registrationhttp://www.choa.org/Pediatric-Research/Research-Visit-Pre-Registrationhttp://www.choa.org/Pediatric-Research/Research-Visit-Pre-Registrationhttp://www.choa.org/Pediatric-Research/Research-Visit-Pre-Registrationhttp://www.choa.org/Pediatric-Research/Research-Visit-Pre-Registrationhttp://www.choa.org/Pediatric-Research/Research-Visit-Pre-Registrationhttp://www.choa.org/Pediatric-Research/Research-Visit-Pre-Registrationhttp://www.choa.org/Pediatric-Research/Research-Visit-Pre-Registrationhttp://www.choa.org/Pediatric-Research/Research-Visit-Pre-Registration


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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http://www.atlantactsi.org/about/citation.htmlhttp://www.atlantactsi.org/about/citation.htmlhttp://clinicaltrials.gov/


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

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Important Emails:

[email protected]

Manager: [email protected]

Nurses: [email protected]

[email protected]

Tech: [email protected]