5 Study setup

This section, intended for study administrators and those responsible for study documents, describes how to set up and manage studies.

  • Study details and site list criteria
    Permissioned users can set up studies in Oracle Site Select with attributes that help you and your team members track those studies based on various parameters. Parameters include protocol number and title, protocol phase and compound, study status and type, and more.
  • Study data sources
    Choose the data sources that will be used to create the master list for the study. You can also set data source priority to determine outcomes of data merging.
  • Site scoring (weighting)
    Turn site scoring off, or specify the formula used to determine how Oracle Site Select assigns a site score when turned on. Your site selection team can use the scores displayed in the site grid to determine which sites are most likely to meet key study criteria.
  • Study email templates
    Study level email templates can be configured with default and study country specific settings, if necessary. Specify preferred settings for salutation, login options, and more for all non-system site email notifications.
  • Workflows and workflow documents
    Defining a study's workflows involves detailed planning around the order in which sites complete individual workflow tasks, required documents, and site communication. Some organizations define workflows using account level templates, which are available to you at the study level when you choose to Add a new workflow.
  • Feasibility Surveys
  • Milestones
    Define study milestones when you set up your study to help ensure your team stays on track with key study accomplishments like site enrollment targets.
  • Reasons for study exclusion/disinterest
    When an Oracle Site Select user excludes a site from the feasibility process or a site indicates that they aren't interested in study participation, they may need to provide a reason. An administrator in your account can define a list of reasons, and you can modify that list as necessary for your study.