The P ediatric R esearch C enter

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

2. 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

3. PRC Staff Michelle Popler, RN, BSN Senior Research Nurse Jessica Heyer, RN, BSN Research Nurse Elizabeth Liu, EMT Research Coordinator/Patient Care Tech.

4. Where Are We? Location: Tower 2 Butterfly elevators 2ndFl, 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

5. Directions From admissions to the PRC

6. 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 ServicesJim Rhodes, james.rhodes@choa.org Research lab provides lab processing and shipping servicesDiana 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.

7. PRC Nursing Services • Nursing assessment • Vital Signs and Measurements • Phlebotomy • IV infusions • Roundtable Review • Protocol Order Review • Scheduling Assistance • Safety Oversight

8. How to get your study in the PRC Click here for 1 page guideor visit: http://www.pedsresearch.org/clinical-research/pediatric-research-center

9. How to get your study in the PRC P R C 1 P A G E

10. PRC Guidelines Guidelines can be found here: http://www.pedsresearch.org/clinical-research/pediatric-research-center

11. Finance & Feasibility Kris Rogers Director of Research and Academic Administration Office of Sponsored Programs Grants Administration Pre-Award Office of Grants Accounting Post-Award Shanta Laurie Manager Office of Sponsored Programs OSP@choa.org Chuong Pham Manager Grants Administration grantsadmin@choa.org Shakeeta Nicholson Manager Office of Grants Accounting officeofgrantsaccounting@choa.org Gigi Davis Clinical Trial Feasibility Coordinator Eme Anderson SR OSP Analyst Lori Brown Sr Sponsored Res. Admin Qiana Ayana SR OSP Analyst RodrigusMolden Senior Grants Financial Coordinator Deanna West Sponsored Research Admin Dietre May Grants Financial Coordinator Shareena Pettway Sponsored Research Coordinator Kesia Hudson Grants Financial Coordinator

12. Finance Breakdown • 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. 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

14. 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.

15. ACTSI Submission Submit below items to: cnetwor@emory.edu 1. ACTSI Form E X A M P L E • 2. IRB documents • (can be pending) • 3. PRC Draft Orders

16. 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

17. PRC Checklist • Submit Order sets to: PRC@choa.org using our Order Set Template • Once approved by SAC, schedule roundtable meeting with PRC team • Orders will be reviewed at roundtable • 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. PRC Checklist • Provide PRC with ACTSI SAC approval letter • Organize In-service needs: Research lab, pharmacy, EKG, ECHO, etc. • Order necessary equipment and supplies

19. 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 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

20. Obtaining CR-Assist Access CR-Assist Study Setup Form E X A M P L E

21. 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

22. 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

23. Not a CHOA Employee? CHOA Credentialing Contacts: 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)

24. 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*

25. 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

26. 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

27. 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

28. 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)

29. 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

30. 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

31. 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