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

Transcription

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 2

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

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

5 Directions From admissions to the PRC 5

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 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. 6

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

8 How to get your study in the PRC Click here for 1 page guide or visit: 8

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

10 PRC Guidelines Guidelines can be found here: 10

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

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 12

13 CHOA Routing Checklist Complete Intent to Submit Form: 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 13

14 ACTSI Submission ACTSI submission info.: 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 ACTSI Submission Submit below items to: 1. ACTSI Form 2. IRB documents (can be pending) 3. PRC Draft Orders E X A M P L E 15

16 SAC Meeting Schedule: 2014 Completed submissions head to SAC for review Should be submitted 3 weeks prior to scheduled SAC meeting Committee Meeting Date Submission Deadline SAC 2 January 14, 2014 (Tue) SAC 3 February 13, 2014 (Thu) SAC 1 March 13, 2014 (Thu) SAC 2 April 8, 2014 (Tue) December 24, 2013 January 23, 2014 February 20, 2014 March 18, 2014 Check the SAC Meeting Schedule 2014 Schedule here SAC 3 May 8, 2014 (Thu) SAC 1 June 12, 2014 (Thu) SAC 2 July 8, 2014 (Tue) SAC 3 August 14, 2014 (Thu) SAC 1 September 11, 2014 (Thu) SAC 2 October 14, 2014 (Tue) SAC 3 November 13, 2014 (Thu) SAC 1 December 11, 2014 (Thu) April 17, 2014 May 22, 2014 June 17, 2014 July 24, 2014 August 21, 2014 September 23, 2014 October 23, 2014 November 20,

17 PRC Checklist Submit Order sets to: using our Order Set Template 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 Once approved by SAC, schedule roundtable meeting with PRC team Orders will be reviewed at roundtable 17

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 18

19 Obtaining CR-Assist Access CR-Assist: ACTSI research appointment hub Info: Contact Khushbu Amin for access and send completed study form to CR-Assist Access Form Contact Audrey Kelly at for CR-Assist training & study visit set up after Khushbu s approval 19

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

21 Other ACTSI Research Resources More Info on Services offered: 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 21

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

23 Not a CHOA Employee? 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] ( ) CHOA Credentialing Contacts: Name Title CHOA Ext. Provider Last Name Kuklinski, Lisa Manager N/A Lowry, Susan Supervisor N/A Morris, Enriquita Brzezinski, Vickie Credentialing Coordinator Credentialing Coordinator A, B, V, X, Y, Z J, L, T, W Guda, Susan Credentialing Coordinator M, N, O, P 23

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* 24

25 For Clinical Credentialing: You will need: Contact Susan Guda in Credentialing Services at (404) Complete Credentialing and Scope of Practice form and application packet obtained from Credentialing Services 25

26 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 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: Visit-Pre-Registration 27

28 Study Completion Publications MUST CITE ACTSI support in publications: Citing ACTSI: "Supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under Award Number UL1TR 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 TR and TL1 Trainees should also list TL1 TR Share with PRC when published Publication of findings in peer reviewed journal Goal to share knowledge and improve care Must register study with (NIH service, public access, ICMJE) 28

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 29

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 30

31 PRC Contacts Important s: Manager: Nurses: Tech: 31