Study Definition module

Structure of a study

When creating a study, you first need to create the basic structure. A study comprises visits (representing the visits of a subject) which contain eForms (data collection forms) which themselves contain questions and question groups.

Click on the headings below to go to the relevant help topics.

Creating the basic study

In order to create a basic study, you need to:

• Create a new study definition

• Create a set of eForms

• Create the individual questions and place them onto the relevant eForms

• Create a number of visits and place the relevant eForms into each visit

Adding features to the basic study

Once you have the basic study, the following features can be added:

• Question validation

• Question derivation

• Reasons for change

• Reasons for Overrule

• Skip conditions

• Authorisation of questions

• Setting up validation of laboratory test results (normal ranges and CTC)

• Scheduling constraints

• Subject registration

• References

It is possible to set up studies so that subjects are randomised into treatment groups. This is a manual process and is not done from within the Study Definition module. Click here for more information on randomisation.

Click here to see how to adjust the Arezzo memory settings for large studies.