The ‘Study structure’ tab is where you define the sequence of your study forms and build the main outline of the study.

When you first open a new study the study structure will be empty. You will need to customize your structure to fit the needs of your study. 

A study can consist of Visits, Forms, Repeating Data structure and Repeating Data forms, surveys and survey forms, as well as survey packages.

Study structure

The study structure consists of Visits that contain forms. 

For example, the first Visit might represent your first study visit and it could contain a form with demographic data. Visits can be used to create relevant sections of the study or all planned study visits for all the subjects (patients).

For example, a randomized controlled trial study can contain multiple Visits, which has to be filled in by clinicians for all the patients. Each Visit consists of several forms. 

When collecting the data in the forms, Visits can be used to organize forms, so it is easy to switch between different CRFs. In the actual form the Visit Screening does not contain any fields (questions), as only forms can contain the fields (questions). 

This is especially beneficial for studies with a lot of visits and structuring the study in several Visits and forms helps to make the forms more-user friendly.

Repeating Data structure

When working with Repeating Data, instead of Visits you are adding Repeating Data themselves. For example, you can add an Adverse event Repeating Data or Medical history Repeating Data structure. Repeating Data only consist of forms, which in turn contain the fields (questions). For example, screenshot below shows an Adverse event Repeating Data with one form, Event details:

Surveys and Survey Packages structure

Surveys and Survey Packages structure follows the same logic as Repeating Data. You will need to add a survey which will consist of forms. 

The screenshot below shows a ‘Short Form Health Survey SF-36’ survey which contains one form SF36:

If you want to send a survey, you have to create a survey package. Survey Packages can contain one or multiple surveys. In the survey package, you define the email sender, email subject and email body text (invitation text) that is sent to the participant. The body text should contain the tag {url} - in the 'real' email, the tag will be replaced with a unique link that leads to the survey(s) that the participant can fill in.

Data Standardization

The Data Standardization feature enhances the management of export files and facilitates more effective analysis of variables within the same category. It organizes variables by visit and domain, available for CSV and SAS exports. 

For further reference, please check the article here.

Form Sync

The ‘Study structure’ tab also contains ‘Form Sync’ subtab which allows  for each production study to have a corresponding test environment. 

Learn more on how to use the Form Sync feature in the article: Using Test and Production Study Environments: CDMS