SARC Submission Process

NIH Sponsored Studies Cooperative Group/Pilot

Foundation Sponsored StudiesInvestigator Initiated Industry Studies

Pat Kittelson MLSUCH CTRC Administration

Acronym Soup

2

Acronym Soup 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

CTO/CTRC COMIRB HRRC/RI

HRRC/RI

CTO

CTRC

4

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

HRRC/RI submissionHRRC/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

General Clinical Research Centers1962 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

Colorado Clinical and Translational Sciences Institute Organizational Pillars

Child and Maternal Health Research

Education, Training and Career Development

Evaluation and Tracking

New Methods and TechnologiesPilot Projects Translational Technology Cores New Methods

Translational Research Informatics

Discovery Translation ResearchCTRCs CTOs BERD Regulatory Knowledge & Support

Community Translation

Clinical Translational Research Centers Network2008

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

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)

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

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

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

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

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

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

IRB Continuing Review

Please remember to submit continuing review approval and newly stamped consents each year to ctrc.protocols

17

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

People soupCTRC protocol submission - Nikki Arnold CTRC.protocols@ucdenver.edu

CTO protocol submission - Susan Switzsusan.switz@uch.edu

HRRC protocol submission - Mary Schumermary.schumer@uch.edu

RI protocol submissionResearchApproval@childrenscolorado.org

Biostatistics – John Nealjohn.neal@ucdenver.edu

Informatics - REDCaphttp://cctsi.ucdenver.edu/RIIC/Pages/ContactInformatics.aspxatics

19

UCH CTRC Administration - budgetspat.kittelson@ucdenver.edu 720-848-6226

CTRC Bionutritionjanine.higgins@childrenscolorado.org

UCH Clinical/Nursing Outpatienttimothy.woodworth@uch.edu

UCH Clinical/Nursing Inpatientjoni.donahoo@uch.edu

UCH Core Labpamila.allen@ucdenver.edu or kayla.carstens@ucdenver.edu

UCH Research Subject Advocatebarbara.hammack@ucdenver.edu

20