When To Create New Project vs. Add Variables to Existing Project

Overview

There are times new variables are targeted for collection and the user needs to determine whether to add the variables to an existing Project or create a New Project.  Most often this question involves a registry, since clinical trials/observational studies nearly always involve just adding to the existing Project.  Below are the main questions to answer that give weight to determining what's best. 

Data Collection:

  • Is the data collection schedule for the new variables match the existing interval structure?

    • Poor match → lean toward separate project
  • What's the impact on Completion status (e.g., will it change? Complete / Incomplete / Unknown)
    • Greater change → lean toward separate project
  • Is there a logically place to fit new variables within the existing data entry forms?
    • Poor fit → lean toward separate project
  • What's the data entry burden across subjects?
    • Are all sites participating?
      • Only partial sites → lean toward separate project
    • Will the new variables be collected going forward indefinitely?
      •  No → lean toward separate project
    • How many subjects will be impacted?
      • Fewer the subjects → lean toward separate project
    • Are the new variables to be entered by the subjects?
      • Yes → lean toward separate project
      • Will it be ok for subjects to access/edit previous encounters?
        • No → lean toward separate project
      • Notification requirements to subjects?
        • The more extensive → lean toward separate project

Scope of Effort:

  • How involved will it be to integrate with exiting variables and skip logic?
    • More involved → lean toward separate project