Study structure

Transcript:

  • Castor makes a distinction between the study forms, reports and surveys
  • Study forms are the actual “Case Report Form”. 
  • When a record is created, all these forms will be automatically created.
  • A record represents all information about a study participant
  • Phases are periods in a study, e.g. "Baseline", "Visit 1" etc. These can have a specified duration, e.g. 2 months. 
  • Only study forms contain phases, not reports or surveys.
  • Reports are repeating forms and can be used for repeating data such as Adverse Event Reports, medication and blood pressure measurements.. 
  • They have a “one-to-many” (1:N) relation with the record. 
  • In other words, when it is not known in advance how many times a specific measurement will be performed or how often an event (e.g. adverse event) will occur, it is recommended to use a report. 
  • Surveys are questionnaires that can be sent directly to participants using their email address or are able to be printed out and completed by hand.
  • Surveys are sent in a survey package.
  • Steps are sections inside a Study Phase, reports or a survey. 
  • A Study Phase can have as many steps as you like. A step groups one or more related questions, (fields). For example, a Demographics step can contain questions related to age, gender.
  • Steps can be used to break up longer forms, and make the CRF user friendly and less bulky.
  • Steps are also present in reports or survey forms. 
  • Each Step can have any number of questions, but we recommend keeping the number of Fields per Step low, to make sure that the forms are user friendly and are not too long. 
  • Fields are the most important part of the study, they are the actual questions in your eCRF.