Study Design

The SC CTSI team assists investigators with a range of study design issues. This may include but is not limited to:

• formulating aims and hypothesis
• selecting best study type (cross-sectional, longitudinal, case-control, cohort, trial, etc.)
• defining a sampling strategy
• estimating sample size and power (estimating study effect size, numbers of subjects required to statistically detect the hypothesized effect)
• design of a randomized clinical trial
• defining the target and study population
• defining the interventions or exposures (independent variables)
• defining length of trial follow-up
• defining primary, secondary and other trial outcomes (dependent variables)
• defining safety outcomes
• method of assignment of subjects to interventions

The SC CTSI team supports development of feasible and valid study designd, efficient and accurate data collection and analysis, and assistance for researchers in avoiding translational research pitfalls. 

An initial one-hour free consultation is provided to assess project needs, identify appropriate services, and determine the number of hours or level of effort required for the project. Any additional consultation time will be provided on a recharge basis. Investigators may qualify for free consultation hours through one or more of the categories below; however, the maximum number of free consultation hours available per investigator across all projects per fiscal year is 15, including initial consultation hours. Following the initial consultation, investigators will receive a recommended scope of work and cost estimate.

Rates

**Rate includes salary & fringe

Pricing & Billing Notes

• The rates shown are blended rates for SC CTSI services and reflect the combined cost of personnel, expertise, and operational support required to provide the service.
• The rates shown include all applicable salary and fringe benefit costs.
• Services are billed as “Other Materials and Supplies (SC0243)” through the USC Priority Software FBS platform monthly.
• Non-industry rates apply to academic, government, foundation, and non-profit funded research projects and are partially subsidized by SC CTSI.
• Industry rates apply to research funded or sponsored by commercial, for-profit organizations, including pharmaceutical, biotechnology, and medical device companies.
• Annual effort-based rates represent 100% effort; costs are prorated based on the level of effort requested and the project duration.
• Organizations outside of USC and CHLA are subject to an additional 30.5% indirect cost (overhead) rate on professional service agreements.
• For grant-funded projects, investigators are encouraged to engage the CE Team during proposal development to ensure adequate resources are budgeted for community engagement activities.

Discount Categories: Eligibility for discounted services is determined by the BERD Consultant. Investigators may qualify for free consultation hours through one or more of the categories below based on their role in the associated IRB protocol, funded award, or project. However, the maximum number of free consultation hours available per investigator across all projects per fiscal year is 15 hours, inclusive of initial consultation hours.

• Initial Consultation: (up to 1 hour): Free for any project based at USC, CHLA and affiliated SC CTSI institutions.
• SC CTSI Pilot Funding Awardees: (up to 2 hours*): Any SC CTSI Pilot Funding Awardee can receive up to 2 hours free for work related to the funded project.
• Junior Investigators: (up to 5 hours*): Junior Investigators, as defined by NIH and/or in an Assistant professor classification may receive up to 5 free hours of support per project for up to two projects per fiscal year.
• K Awardees: (up to 15 hours annually*): All K awardees may receive up to 15 hours free in total annually for their K – related project based at USC, CHLA and affiliated SC CTSI institutions.
• T Scholars: (up to 15 hours annually*): All T scholars may receive up to 15 hours free in total annually for their T – related project based at USC, CHLA and affiliated SC CTSI institutions.
• Extramural Grant Planning: (up to 3 hours*): Researchers seeking support in the preparation of grants for submission within 6 months, may receive up to 3 free hours of services in support of the grant application. This includes consultation on issues related to:
  • Study/experimental design
  • Power/sample size
  • Randomization schema
  • Statistical analysis plan
  • Analysis/Interpretation of results
  • Data acquisition plan
  • Data cleaning and management
  • Data sharing plan
  • Other
• PM516 Volunteers: (up to 5 hours* outside of class): Maximum of four PM516 Volunteers annually may receive up to 5 free hours each of services in support of the project volunteered to the class (in addition to student/class time).