1. SARC Submission Process NIH Sponsored Studies Cooperative Group/Pilot Foundation Sponsored Studies Investigator Initiated Industry Studies Pat Kittelson MLS UCH CTRC Administration

2. Acronym Soup 2

3.  BERD – Biostatistics, Epidemiology and Research Design  CCTSI = Colorado Clinical and Translational Science Institute  CMH = Child and Maternal Health  COMIRB = Colorado Multiple Institute Review Board  CRRF = Clinical Research Resources and Facilities  CTO = Clinical Trials Office (Susan Switz at UCH)  CTRC = Clinical Translational Research Center  DOS = Date of Service  EPIC = Children’s Hospital and University Hospital Software  HRRC = University Hospital Research Resource Center (Mary Schumer)  MRN = Medical Record Number (assigned to patients)  NIH = National Institute of Health ( Largest Federal funding agency of clinical research)  RI = Research Institute at Children’s Hospital Colorado  RSA – Research Subject Advocate = safety oversight of research participants  SARC = Scientific Advisory and Review Committee (for studies using CTRC)  WIRB = Western Institutional Review Board (Industry studies) 3

4. CTO/CTRC  COMIRB  HRRC/RI HRRC/RI CTO CTRC 4

5. CTO submission CTO criteria  Industry Initiated  Industry funded studies  Fee for service  No SARC review Submit:  Protocol  CTO Attachment W2  CTO/HRRC Budget  Investigator Brochure (if applicable)  DSMB (if applicable) 5

6. HRRC/RI submission HRRC/RI criteria  Any and all research conducted in hospitals  May have multiple sources of funding  May have SARC review Submit:  HRRC Application (including Budget Worksheet)]  IRB Approval Letter  IRB Application  Consent Form  HIPAA Authorization  Full/Master protocol or grant  Clinical Trial Agreement and original budget 6

7. General Clinical Research Centers 1962  Vail Ski Area opened in 1962  1962 Jaguar price $8,000  Purpose to provide clinical space and research personnel plus financial support for Federally funded (NIH) clinical research studies.

8. 8 Colorado Clinical and Translational Sciences Institute Organizational Pillars Child and Maternal Health Research Education, Training and Career Development Evaluation and Tracking New Methods and Technologies Pilot Projects Translational Technology Cores New Methods New Methods and Technologies Pilot Projects Translational Technology Cores New Methods Translational Research Informatics Discovery Translation Research CTRCs CTOs BERD Regulatory Knowledge & Support Discovery Translation Research CTRCs CTOs BERD Regulatory Knowledge & Support Community Translation

9. Clinical Translational Research Centers Network 2008 Stayed the same  Funded by NIH  Clinical Research Center structure preserved  Funded for 5 years  Committed to providing clinical research infrastructure  Scientific Review required for all studies utilizing CTRC space and/or services Changed  Broader, more encompassing campus research (i.e. education, community outreach)  Children’s, UCH CTRC’s merged into CTRC network  Increased need for cost recovery/fee for service – limits on financial support  Able to accommodate Foundation and Investigator Initiated Studies

10. Structure of CTRC Network  Controlled environment –Inpatient units/outpatient clinics  Clinical Services/ Nursing  Core Laboratories  Bionutrition –Metabolic kitchen  Informatics/Biostatistics  RSAs  Children’s Hospital  University of Colorado Boulder  University of Colorado Hospital  National Jewish Health  Perinatal (Child and Maternal Health)

11. Part 1: Scientific Review - SARC  Submit protocol and CTRC Utilization Form (Attachment W or U) to ctrc.protocols@ucdenver.edu  Two SARC panels  Meetings on first and third Monday of each month  Study is checked for feasibility by Administration (budget), Clinic (nursing and other services), Laboratory, Nutrition  Study and budget information are sent to HRRC and RI (further budget development will occur during review)  Study is reviewed by SARC panel, SARC chair, biostatistics

12. Following SARC review  Chair memo is sent to the PI  Changes are made and the Protocol is sent back to ctrc.protocols  SARC review is completed  Protocol is “locked” - no further changes before COMIRB review 12

13. Part 2: IRB/COMIRB  Navigator and Research Subject Advocate are available for COMIRB document preparation  RSA reviews COMIRB documents and signs off  RSA fast-tracks COMIRB submission (eliminates pre-review)  COMIRB reviews, processes changes, approves  Submit COMIRB approval (Certificate and Stamped Consent to CTRC.protocols) 13

14. Part 3: Hospital Approvals  Research Institute - RI  University Hospital – HRRC  Usually ctrc.protocols is notified of hospital approvals – it’s a good idea to check and be sure this has been received.  Study set up in EPIC  NOTE: during this time you should be working with clinical staff (to develop orders and flow sheets) nutrition, lab and administrative staff 14

15. Part 4: Protocol Implementation Meeting  PI meeting scheduled –Purpose to do a final check with CTRC staff –Learn about participant scheduling processes –Review nursing orders and flow sheets –Learn about billing processes 15

16. Ready to rock and en-roll  Once COMIRB approval is received, you may recruit subjects  Participants may be seen and consented in the CTRC only after all approvals are in place  When all participant visits have ended on the CTRC – please notify ctrc.protocols so the study can be closed to clinical use. 16

17. IRB Continuing Review  Please remember to submit continuing review approval and newly stamped consents each year to ctrc.protocols 17

18. Study Amendments  Amendments should receive COMIRB approval first and then be submitted to ctrc.protocols  NOTE: study amendments that may affect the budget significantly should be reviewed by CTRC administration prior to COMIRB review.  Study staff changes should be submitted to ctrc.protocols so we have current contacts on file 18

19. People soup CTRC protocol submission - Nikki Arnold CTRC.protocols@ucdenver.edu CTO protocol submission - Susan Switz susan.switz@uch.edu HRRC protocol submission - Mary Schumer mary.schumer@uch.edu RI protocol submission ResearchApproval@childrenscolorado.org Biostatistics – John Neal john.neal@ucdenver.edu Informatics - REDCap http://cctsi.ucdenver.edu/RIIC/Pages/ContactInformatics.aspxatics 19

20. UCH CTRC Administration - budgets pat.kittelson@ucdenver.edu 720-848-6226 CTRC Bionutrition janine.higgins@childrenscolorado.org UCH Clinical/Nursing Outpatient timothy.woodworth@uch.edu UCH Clinical/Nursing Inpatient joni.donahoo@uch.edu UCH Core Lab pamila.allen@ucdenver.edu or kayla.carstens@ucdenver.edu UCH Research Subject Advocate barbara.hammack@ucdenver.edu 20