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The Structure of a Study in CDMS

Updated

 

The Study Design and Study Forms builder in Castor CDMS allows you to create and customize your electronic Case Report Form (eCRF). Castor CDMS organizes study into four main components: Visits, Repeating Data, Surveys, and Survey Packages.

 

Visits

  • Visits and forms make up the primary Case Report Form (CRF).
  • When a participant is created, all the Visits and associated study forms are automatically created for them.
  • Visits represent time periods in a study (e.g., "Baseline," "Visit 1").
  • They may have specific durations (e.g., 2 months).

The basic structure of your eCRF is determined by Visits, Forms, and Fields:

 

Forms

  • Forms are sections within a visit, designed to group related questions (for example Demographics or Study inclusion).
  • Each visit can contain multiple forms to enhance usability and reduce complexity.
  • Forms are also used in repeating data and surveys.

 

Fields

  • Fields are the actual questions in your eCRF.
  • Each form can contain multiple fields, but it is recommended to keep the number of fields per form manageable to improve user experience.
  • Find more about different fields in section Fields and field properties

Fields in the Study forms builder:

 

Repeating Data

  • Repeating data is mostly used for events or measurements that occur multiple times but with an unknown frequency. 
  • It follows a one-to-many (1:N) relationship with the participant.
  • Example: For one participant, there might be two blood pressure measurements, while for another, there could be six.
  • Examples of data stored in repeating data:
    • Adverse events
    • Medications
    • Repeated measurements (e.g., blood pressure).

Find more information on when to use Repeating data in the article: What is the difference between the types of repeating data in EDC/CDMS?

 

Surveys and Survey packages

 

Creating Your Study Structure

To create a basic study structure, you’ll define visits and forms within the Study Design section.

Questions to Consider:

Are the questions answered by a healthcare professional directly in Castor CDMS?

  • Use Visits and forms.

Do the questions have a "one-to-many" relationship?

  • Use repeating data if the frequency of events or measurements is unknown or if multiple measurements needs to be taken and displayed in the data entry view in a table form.

Are the questions going to be sent via email?

  • Use surveys and survey packages or the Castor Connect App.

How should the data be exported?

Example Scenarios

  • Visits and Forms: Use for structured, fixed data collection like a "Baseline Visit."
  • Repeating Data: Use for unpredictable data, like the number of adverse events per participant.
  • Surveys: Use to collect responses directly from participants via email or app.

By asking these questions and structuring your study accordingly, you’ll create an organized and user-friendly eCRF for efficient data collection.

 

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