Case Report Forms

The Case report forms drives the way the form will be used by the interviewers. It defines:

  • Some descriptive information (name, description) that will be displayed in the Amber Collect app,

  • The form and its version to be used,

  • The multiple records policy, which is the strategy to adopt when a case report is saved (based on the individual’s ID). Multiple records can be registered, or only a single one for the same individual. In this latter case a new record can be rejected or can update the existing one,

  • The access permissions,

  • The activity (enabled/disabled).

Note

The translations of the Case report form’s name and description are looked up in the form’s translations configuration.

Note

For now Amber supports only patients data acquisition via an interviewer. In the future versions, it could be possible to capture data about a predefined list of participants (with some selection criteria) or do some self-reporting. The case report form activity could also be scheduled. Please contact us if you have more complex use-cases.

List of case report forms

From the list of case report forms the following operations are available:

Add a case report form

Adding a case report form requires to select a form (in the current study) and its revision. If no revision is defined for the selected form, a new revision will be created. The revision number can be explicitly specified or the latest can be used (not recommended, see How to test a case report form?).

By default a Case report form can be used by all the interviewers. It is possible to restrict the access to the selected users and/or groups.

Delete case report form(s)

To delete several case report forms:

  • Select one or more case report forms in the list,

  • Press the Delete selected case report forms button and confirm.

You can also delete a specific case report form by pressing the case report form’s Delete action button.

Edit a case report form

A case report form can be edited: only the revision number and/or the access permissions can be amended. To change the form, create a new case report form.

Pause/start a case report form

After being created, a case report form is in Paused state: it is not visible by the interviewers. Click on the Play button to activate the case report form. A case report form can be paused at any time: any pending case reports will be rejected at submission time.