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. 

The service is provided in the form of a consultation with an option to purchase additional services on a recharge basis. Investigators may be eligible for multiple categories of discount; maximum number of free hours per investigator per year is 15 hours.

Recharge rates: $125/hour after initial consultation * Free 1-hour initial consultation is included

• 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.
• 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).