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The Pediatric Research Center Clinical Research Center Introduction and Study Submission Guidelines.

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Presentation on theme: "The Pediatric Research Center Clinical Research Center Introduction and Study Submission Guidelines."— Presentation transcript:

1 The Pediatric Research Center Clinical Research Center Introduction and Study Submission Guidelines

2 Children’s Healthcare of Atlanta PRC Leadership 2 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

3 Children’s Healthcare of Atlanta PRC Staff 3 Michelle Popler, RN, BSN Senior Research Nurse Jessica Heyer, RN, BSN Research Nurse Elizabeth Liu, EMT Research Coordinator/Patient Care Tech.

4 Children’s Healthcare of Atlanta Where Are We? Location: Tower 2 Butterfly elevators 2 nd Fl, inside the TDICU Hours: 8:00 – 5:30 PM Phone number: 404-785-0400 4 Facilities available for Coordinators: Fax/Copy/Scan documents in TDICU nurses station Family lounge for patients – i.e. Ice & coffee Computer station in PRC

5 Children’s Healthcare of Atlanta Directions From admissions to the PRC 5

6 Children’s Healthcare of Atlanta PRC Services 6 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.orgjames.rhodes@choa.org Research lab provides lab processing and shipping services Diana Worthington-White, diana.worthington-white@choa.org 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.

7 Children’s Healthcare of Atlanta PRC Nursing Services 7 – Nursing assessment – Vital Signs and Measurements – Phlebotomy – IV infusions – Roundtable Review – Protocol Order Review – Scheduling Assistance – Safety Oversight

8 Children’s Healthcare of Atlanta How to get your study in the PRC 8 Click here for 1 page guide or visit: http://www.pedsresearch.org/clinical-research/pediatric-research- center

9 Children’s Healthcare of Atlanta How to get your study in the PRC 9 PRC1PAGEPRC1PAGE

10 Children’s Healthcare of Atlanta PRC Guidelines Guidelines can be found here: 10 http://www.pedsresearch.org/clinical-research/pediatric-research-center

11 Children’s Healthcare of Atlanta Finance & Feasibility 11 Shakeeta Nicholson Manager Office of Grants Accounting officeofgrantsaccounting@choa.org 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 grantsadmin@choa.org Shanta Laurie Manager Office of Sponsored Programs OSP@choa.org 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

12 Children’s Healthcare of Atlanta Finance Breakdown 12 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

13 Children’s Healthcare of Atlanta 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 CHOA Routing Checklist 13

14 Children’s Healthcare of Atlanta ACTSI Submission ACTSI submission info.: http://www.atlantactsi.org/areas/crn/protocol_submission/index.h tml 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. 14

15 Children’s Healthcare of Atlanta ACTSI Submission Submit below items to: cnetwor@emory.edu cnetwor@emory.edu 1. ACTSI FormACTSI Form 15 2. IRB documents (can be pending) 3. PRC Draft Orders EXAMPLEEXAMPLE

16 Children’s Healthcare of Atlanta SAC Meeting Schedule: 2014 CommitteeMeeting DateSubmission 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 16 Completed submissions head to SAC for review Should be submitted 3 weeks prior to scheduled SAC meeting Check the SAC Meeting ScheduleSAC Meeting Schedule 2014 Schedule here

17 Children’s Healthcare of Atlanta PRC Checklist Submit Order sets to: PRC@choa.org using ourPRC@choa.org Order Set Template Once approved by SAC, schedule roundtable meeting with PRC team Orders will be reviewed at roundtable 17 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

18 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 18

19 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.htmlhttp://www.atlantactsi.org/areas/crn/cr- assist/index.html  Contact Khushbu Amin for access and send completed study form to Kamin5@emory.eduKamin5@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 approvalAudrey.kelly@emoryhealthcare.org 19

20 Children’s Healthcare of Atlanta Obtaining CR-Assist Access 20 CR-Assist Study Setup Form EXAMPLEEXAMPLE

21 Children’s Healthcare of Atlanta Other ACTSI Research Resources 21 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) 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

22 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 1 st visit Patient must be re-registered after 1 year Subject comes to PRC for consent and treatment 22

23 Children’s Healthcare of Atlanta Not a CHOA Employee? 23 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 ChecklistCredentialing Checklist  Scan form to CHOA Clinical Research Credentialing Rep: Saadia Khizer saadia.khizer@choa.org (404-785-9893)saadia.khizer@choa.org NameTitleCHOA Ext.Provider Last Name Kuklinski, LisaManager404-785-7485N/A Lowry, SusanSupervisor404-785-7487N/A Morris, Enriquita Credentialing Coordinator 404-785-7492A, B, V, X, Y, Z Brzezinski, Vickie Credentialing Coordinator 404-785-6798J, L, T, W Guda, SusanCredentialing Coordinator 404-785-2198M, N, O, P CHOA Credentialing Contacts:

24 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* 24

25 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 25

26 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 26

27 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-Registrationhttp://www.choa.org/Pediatric-Research/Research- Visit-Pre-Registration 27

28 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/http://clinicaltrials.gov/ (NIH service, public access, ICMJE) 28

29 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 29

30 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 30

31 Children’s Healthcare of Atlanta PRC Contacts 31 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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