Transcript CTRC Clinical & Translational Research

CTRC
Clinical &
Translational
Research
Center
843-792-8300
http://sctr.musc.edu
SCTR Programs
CTSA
GCRCResearch
ResearchEnvironment
Environment
Upgraded
Regulatory
Clinical
Research
Ethics
Upgraded
Biostatistics
Community
Engagement
Training
Programs
843-792-8300
Clinical
Research
Design
Program
Upgraded
Informatics
Translational
Cores
SUCCESS
Center
Master of
Clinical Research
(MSCR)
http://sctr.musc.edu
GCRC
CTRC
Specialized
Health
Centers
Types of Research the CTRC Assists
The CTRC can support the following:
 Investigator-initiated funded research:
> Federal
> Foundation/Organization
> Department/Division
> Industry sponsored
 Industry-initiated, industry sponsored research
 Unsponsored research
 Pilot Projects
843-792-8300
http://sctr.musc.edu
CTRC Services
Nursing
Laboratory
• Processing
• DNA/RNA Isolation
• Assays
• Phlebotomy
• EKG
• Infusion
• Specimen Collection
Imaging
Nutrition
• PeaPod
• DEXA
• BodPod
843-792-8300
• Anthropometrics
• Nutrition Assessment
• Meals & Snacks
http://sctr.musc.edu
CTRC Nursing Services
Complex Urine Collection
IV Infusion Hydration
Saliva Collection
Access/De-Access Port
IV Infusion Non CHEMO
Serial Blood Draw
Dip Urinalysis
IV Push CHEMO
Simple Urine Collection
EKG
IV Push Non CHEMO
TB Test Including Medication
Fingerstick/Heelstick/Capillary
Blood Draw
Mixed Meal Tolerance Test
Urine Cotinine Test
IM/Sub Q/Intradermal
Medication Administration
Observation/Medical
Technician
Urine Drug Screen
Medication Administration
Observation/Skilled Nurse
Urine Pregnancy Test
IV Access
Off Site Visit
Venipuncture
IV Infusion CHEMO
Questionnaires
Vitals
843-792-8300
http://sctr.musc.edu
CTRC Imaging Services
BodPod
BodPod with Thoracic
Volume
PeaPod
DEXA Total Body
DEXA Hip/Spine/Forearm
Imaging Training Services
843-792-8300
http://sctr.musc.edu
CTRC Laboratory Services
ACTH Assay
Leptin Assay
Process and Same-Day Ambient Shipment
Adiponectin Assay
Salivary Alpha Amylase
Assay
Process, Store, Future Frozen Shipment
ADMA Assay
Salivary Cortisol Assay
Process & Frozen Sample Storage
IFN-Gamma Assay
Salivary DHEA Assay
Process Only
IL-1 Beta Assay
TNF Alpha Assay
Process and Same-Day Frozen Shipment
IL-10 Assay
Insulin Assay
FreezerWorks Report
IL-6 Assay
DNA/RNA Isolation
Dry Ice
843-792-8300
http://sctr.musc.edu
CTRC Nutrition Services
Anthropometry
Portable Indirect
Calorimetry
Nutrition Assessment
Standard Boxed Meal
Nutrition Controlled Meals Standard Boxed Snack
Patient Education
843-792-8300
Weighed Nutrient
http://sctr.musc.edu
CTRC Facilities
The 9,200 square foot outpatient facility on the 2nd
floor of MUSC’s Clinical Sciences Building includes:
 8 examination rooms
 3 procedure rooms
 1 dental suite
 Imaging/body evaluation suite
 Core laboratory
843-792-8300
http://sctr.musc.edu
CTRC Facilities (Cont.)
Specialized equipment and facilities
include:
 Dynamap readers in all rooms
 Fully equipped dental suite
 Body composition
 Dexascan machine for bone density
measurements
 BodPod system for body measurements in 8250kg individuals
 PeaPod system for body measurements in 18kg infants
843-792-8300
http://sctr.musc.edu
Why Use the CTRC?
 Nursing staff with over 100 years of
cumulative experience in clinical trials
 Nurses have expertise to work with infants to elderly
 CTRC nurses are trained in good clinical practice, CITI
training, basic life support, chemotherapy
administration
 CTRC is recognized by study sponsors as a facility that
provides quality data
843-792-8300
http://sctr.musc.edu
Why Use the CTRC (continued)?
 Nursing staff use stop watches to ensure accurate
timing for blood draws and other timed
assessments/procedures
 Timed blood draws (procedures) are done within
seconds of that specified in protocol
 The CTRC clinic is outfitted with all necessary
equipment for routine medical care so investigators
don’t need to bring their own equipment
 Fee for service structure allows PI to conduct
complicated clinical trials without paying for a full-time
medical clinician
843-792-8300
http://sctr.musc.edu
Cost Recovery Program
Funded Investigator-Initiated Research
(Federal, Foundation, Organization, InvestigatorInitiated Industry Sponsored, or Department)
 Studies that do not have enough funding to
cover CTRC fees or cannot re-budget to include
them may apply for CTRAC approval of a SCTR
subsidy for up to ½ the cost of services not to
exceed$50,000 per study
843-792-8300
http://sctr.musc.edu
Cost Recovery Program (Cont.)
Industry-Initiated, Industry Sponsored
Research
 Research rates are available to industry
sponsored trials for CTRC services. These
studies do not qualify for CTSA funding
support through SCTR subsidy or voucher
funding.
843-792-8300
http://sctr.musc.edu
Cost Recovery Program (Cont.)
Unfunded Research
 CTRC-provided services are available at no
charge to qualified unfunded research studies
up to $50,000 per study with CTRAC approval.
843-792-8300
http://sctr.musc.edu
Cost Recovery Program (Cont.)
Priority Funding Areas
These specially targeted funding areas are eligible
for up to $50,000 in CTRC services without a
required funding match.
 SCTR Pilot Projects
 Internally supported research with less than
$10,000 in funding
 K Awardees and other trainees with $25,000 or
less in research support
843-792-8300
http://sctr.musc.edu
CTRC Protocol Review & Approval
Is your protocol
investigator
initiated?
NO
Expedited review by
the CTRC Operations
Director within 7
days from the time of
submission.
843-792-8300
YES
Is your protocol
funded?
YES
Are you
requesting a
SCTR subsidy?
NO
NO
Full CTRC Advisory
Committee review
for potential approval
of a SCTR subsidy.
Expedited review by
the CTRC Operations
Director within 7
days from the time of
submission.
http://sctr.musc.edu
YES
Full CTRC
Advisory
committee
review.
Applying for SCTR Services
Applications for any SCTR
service can be requested
through the SCTR
Programs Application &
Request Kiosk (SPARK) at
http://sctr.musc.edu/spark
843-792-8300
http://sctr.musc.edu