Our Data Management Team offers a variety of services to support your study and we will work with you to define what services your study will require given your budget and time constraints.  Note:  We offer assistance for grant preparation at no cost.

Grant Preparation

  • Assist with protocol development
  • Provide DM budget estimates and justification
  • Write data management plan
  • Manage pilot study data used for grant submission

Study Start-Up (prior to enrollment)

  • Review/assist with finalizing protocol
  • Coordinate/facilitate start-up meeting
  • Identify analysis timeline
  • Define/Design /Develop system requirements and processes, data collection instruments, i.e. CRFs
  • Define study and site performance metrics
  • Define study requirements including primary and secondary outcome variables
  • Define QA/QC plan and methods
  • Develop/assist in documenting standard operation procedures/guidelines (SOPs/SOGs)
  • Implement randomization scheme/process of study participants

Study Conduct

  • Coordinate/facilitate and/or oversee study data collection efforts
  • Perform ongoing QA/QC monitoring
  • Generate tracking/summary reports
  • Create datasets
  • Conduct preliminary and descriptive analysis
  • Engage and communicate
  • Provide ongoing study support

Study Closure

  • Conduct final QA/QC of data
  • Produce and distribute final close out documentation
  • Produce and distribute final data sets
  • Perform final data sharing responsibilities
  • Prepare and submit data and documentation to government agencies and/or institutions defined per protocol
  • Archive system, database, data sets, programs, and documentation

Department of Biostatistics | 410 W. Tenth St., Suite 3000 | Indianapolis, IN 46202 | Ph: (317) 274-2661 | Fax: (317) 274-2678