Module references create links between forms and SMART-TRIALS other modules, for now there can be created links to Unscheduled Events, (s)AE reports and Medication (concomitant and IMP).
Module references are setup like questions when creating a form, just like questions they can be hidden by show rules, and only shown when relevant. As an example, by adding a show rule to the module reference, you can choose that this particular module reference should only be visible if a specific answer is given. To see more, please go to our Show rules article.
To create a module reference:
- Go to [Study Name] > Forms, or [Study Name] > Study Info.
- Click + New Form or select an already existing form to which the module reference should be added.
- (Enter the name of the form and specify the form details)
- Click + Module reference.
- Select the type of reference (question type) and specify the question details.
- Click Save Form.
The references are ‘filled in’ during form fill out. Each type of module reference allows the user to either select a previously created unscheduled/(S)AE report, or medication, OR creating a new entry without having to leave the form!
Please note that creating a new Unscheduled or AE report will save your form (your form must therefore be in a saveable state) and take you to the AE/Unscheduled fill out view. Upon completion the system will return you to the form fill out, right where you left off!
Creating a new Unscheduled allows you to select which optional forms to fill out. The mandatory and optional form are selected during setup of the process.
Previously created entries (AE/unscheduled/medication) cannot be edited directly from form fill out via the module reference system.
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