Transcript Presentation CTRC Submission Process

SARC Submission Process
NIH Sponsored Studies
Cooperative Group/Pilot
Foundation Sponsored Studies
Investigator Initiated Industry Studies
Pat Kittelson MLS
UCH 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
CTRC
CTO
HRRC/RI
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 submission
Submit:
 HRRC Application
(including Budget
HRRC/RI criteria
Worksheet)]
 Any and all research
 IRB Approval Letter
conducted in hospitals
 IRB Application
 May have multiple
 Consent Form
sources of funding
 HIPAA Authorization
 May have SARC review  Full/Master protocol or
grant
 Clinical Trial Agreement
and original budget
6
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.
Colorado Clinical and Translational Sciences Institute
Organizational Pillars
Child and Maternal Health Research
Community Translation
CTRCs
Discovery Translation Research
CTOs BERD Regulatory Knowledge & Support
Translational Research Informatics
New Methods and Technologies
Pilot Projects Translational Technology Cores New Methods
Education, Training and Career Development
Evaluation and Tracking
8
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
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
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 soup
CTRC protocol submission - Nikki Arnold
[email protected]
CTO protocol submission - Susan Switz
[email protected]
HRRC protocol submission - Mary Schumer
[email protected]
RI protocol submission
[email protected]
Biostatistics – John Neal
[email protected]
Informatics - REDCap
http://cctsi.ucdenver.edu/RIIC/Pages/ContactInformatics.aspxatics
19
UCH CTRC Administration - budgets
[email protected] 720-848-6226
CTRC Bionutrition
[email protected]
UCH Clinical/Nursing Outpatient
[email protected]
UCH Clinical/Nursing Inpatient
[email protected]
UCH Core Lab
[email protected] or [email protected]
UCH Research Subject Advocate
[email protected]
20