► Pediatric Epidemiology report for ISSUU

The division of pediatric epidemiology also houses the Clinical Research Unit (CRU). The function of this unit is to provide resources for clinical research for both the project development phase as well as throughout the entire project. The CRU is most appropriately used for the following:

• studies designed to obtain preliminary data for a subsequent grant submission
• projects to establish the ability of the research team to conduct an investigation
• short term projects to help define outcomes, develop protocols, or establish data collection techniques
• exploratory projects for hypothesis generation
• student, fellow, or faculty short term projects

The CRU can provide assistance in the following research areas:

• Hypothesis development and measurement of interim and final outcome markers
• Research design (RCT, Cohort, Case Control, Therapeutic, Prevention, etc.)
• Sample size calculations for statistical power
• Sample size estimations to account for patient attrition, loss to follow up, etc.
• Randomization schemes (very simple to stratified, blocked designs)
• Design data collection forms
• Development of computerized data bases
• Entry of abstracted data into computerized data bases
• Management of research data bases for internal quality control
• Statistical design and analysis
• DSMC activities such as interim analysis, stop rule committee, adverse event reporting, etc.
• Web based randomization and enrollment for multi-center trials
• Data Coordinating Center for multi-center trials and FDA monitored trials
• Assistance with IRB submissions
• Compliance with HIPAA and other regulatory requirements
• Grant writing on any of the above