C T R C Clinical & Translational Research Center

SCTR Programs

SUCCESS Center GCRC Research Environment GCRC Specialized Health Centers Training Programs Master of Clinical Research (MSCR) Clinical Research Design Program Upgraded Biostatistics Upgraded Regulatory Community Engagement Clinical Research Ethics Translational Cores CTRC Upgraded Informatics CTSA Research Environment

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 Types of Research the CTRC Assists

Nursing Imaging CTRC Services Laboratory Nutrition Phlebotomy EKG Infusion Specimen Collection PeaPod DEXA BodPod Processing DNA/RNA Isolation Assays Anthropometrics Nutrition Assessment Meals & Snacks

CTRC Nursing Services

CTRC Imaging Services

CTRC Laboratory Services

CTRC Nutrition Services

The 9,200 square foot outpatient facility on the 2 nd floor of MUSC’s Clinical Sciences Building includes:  8 examination rooms  3 procedure rooms  1 dental suite  Imaging/body evaluation suite  Core laboratory CTRC Facilities

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 kg individuals  PeaPod system for body measurements in 1- 8kg infants CTRC Facilities (Cont.)

 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 Why Use the CTRC?

 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 Why Use the CTRC (continued)?

Funded Investigator-Initiated Research (Federal, Foundation, Organization, Investigator- Initiated Industry Sponsored, or Department) Cost Recovery Program  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

Industry-Initiated, Industry Sponsored Research Cost Recovery Program (Cont.)  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.

Unfunded Research Cost Recovery Program (Cont.)  CTRC-provided services are available at no charge to qualified unfunded research studies up to $50,000 per study with CTRAC approval.

Priority Funding Areas These specially targeted funding areas are eligible for up to $50,000 in CTRC services without a required funding match. Cost Recovery Program (Cont.)  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

Full CTRC Advisory committee review. CTRC Protocol Review & Approval Is your protocol investigator initiated? Expedited review by the CTRC Operations Director within 7 days from the time of submission. Is your protocol funded? Are you requesting a SCTR subsidy? 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. YES NO

Applying for SCTR Services Applications for any SCTR service can be requested through the SCTR Programs Application & Request Kiosk (SPARK) at