sarc submission process nih sponsored studies cooperative group/pilot foundation sponsored studies...
TRANSCRIPT
SARC Submission Process
NIH Sponsored Studies Cooperative Group/Pilot
Foundation Sponsored StudiesInvestigator Initiated Industry Studies
Pat Kittelson MLSUCH CTRC Administration
Acronym Soup
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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)
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CTO/CTRC COMIRB HRRC/RI
HRRC/RI
CTO
CTRC
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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)
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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
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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.
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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 [email protected]
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
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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
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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
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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.
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IRB Continuing Review
Please remember to submit continuing review approval and newly stamped consents each year to ctrc.protocols
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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
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People soupCTRC protocol submission - Nikki Arnold [email protected]
CTO protocol submission - Susan [email protected]
HRRC protocol submission - Mary [email protected]
RI protocol [email protected]
Biostatistics – John [email protected]
Informatics - REDCaphttp://cctsi.ucdenver.edu/RIIC/Pages/ContactInformatics.aspxatics
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UCH CTRC Administration - [email protected] 720-848-6226
CTRC [email protected]
UCH Clinical/Nursing [email protected]
UCH Clinical/Nursing [email protected]
UCH Core [email protected] or [email protected]
UCH Research Subject [email protected]
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