Entering repeated data in CDMS

 

Follow the steps below to learn how to create, manage, and view repeating data instances for a participant.

 

Prerequisites

• Edit permissions are required to create repeating data instances. If you do not see the options described below, contact your Study Manager to request the appropriate access.
• When starting a new study, there will be no repeating data forms. These must be created by a Study Admin in Study Forms > Repeating Data. For more information, see How to Create a New Field.

 

 

Accessing the Repeating Data Tab

1. Open a Participant:
   • Access an existing participant from the Participants tab or create a new one.
2. Go to the Repeating Data Tab:
   • Open the participant and select the Repeating Data tab.
   • The Repeating Data Overview will be displayed for a selected participant.

 

Using Filters

Filters allow you to customize the view of repeating data instances, making it easier to find what you’re looking for. You can filter by the following options:

• Data collection progress: Not started, In Progress, Completed
• Type: Adverse Event, Event, Medication, Other, Repeated Measure, or Unscheduled Visit.
• Status: Archived, Unarchived
• Repeating data name: Select specific names for repeating data instances.
• Parent: Select the type of parent instance to which the repeating data is attached.
   

Filters are persistent, meaning they will remain applied for the logged-in user even if you reload the page or navigate away and return.

If study changes occur (e.g., new data types added or removed), an error message will prompt you to reset your filters, as some previously applied filters might no longer be available.

On smaller screens (e.g., tablets), the search bar is collapsed into an icon for better usability.

1. Click on the Filters button.
2. Select the desired filters
3. Click Apply.

 

Adding a New Repeating Data Instance

It is possible to add a new repeating data instance in two ways, via the Repeating Data Tab or using the Repeating Data button.

 

From the Repeating Data Tab:

1. Click Create.
2. After clicking, the following dialog will appear:
   1. Repeating Data: Choose the type of repeating data to add.
   2. Instance Name: Define a name for the instance. For auto-generated names, a preview is shown, but the final name may differ upon saving.
   3. Parent: Attach the instance to a visit or another repeating data instance:
      1. If attached to a visit, it will also appear in the Visit/Form Navigator if the setting to show repeating data instances is enabled
      2. You can attach instances to other repeating data instances as well (for example, an unscheduled visit or adverse event).

Once the fields are filled, click:

• ‘Create’ to add the instance and start entering data.
• ‘Create and Add Another’ to create and immediately add a new instance.

 

From the data entry view:

1. In the Visits tab, in the relevant form, you might see an Add measurement button which allows adding data to a repeated measure field and display it in the grid format in the data entry.
2. The Repeating Data button allows adding any other type of repeating data instance (adverse event, medication, unscheduled visit, other) from the data entry view.

 

Using Add measurement button

1. Click on the Add measurement button.
   1.  You will be automatically redirected to the repeating data instance data entry view to fill out the repeating data form
2. You can navigate using various Action buttons:
   1. Go back: navigate to the Visit and Form data entry view
   2. Go to parent: Navigates to the parent of this repeating data instance.
   3. All repeating data instances: Redirects to the overview of all repeating data instances for this participant.
   4. Add another: Allows the creation of an additional repeating data instance for this participant.
3.  When creating a repeating data instance using the Add measurement button, the instance will be automatically attached to the parent where the repeated measure field is located. The name will be automatically generated based on the naming strategy defined when the repeating data structure was created.

 

Modern Data Entry (from version 2024.2)

1. In the version 2024.2 and onwards, click on the Add measurement button

2.  You will be automatically redirected to the repeating data instance data entry view to fill out the repeating data form.
3. You can navigate using various Action buttons:
   • Go to parent: Navigates to the parent of this repeating data instance.
   • Add another (+): Allows the creation of an additional repeating data instance for this participant.
   • Navigate to the repeating data overview (←): shows a list of all repeating data instances for this participant.

 

Using Repeating Data button

1. Click on the Repeating Data button during data entry:
   • A dialog window will appear with the following pre-filled details:
     • Repeating Data: The type of repeating data to be created.
     • Attach To: The parent where the repeating data will be linked.
2. Default Name: A default name will be suggested for the repeating data instance.
   • If the option to edit the custom name is enabled, data entry users can rename the instance.
3. Create the Instance:
   • Once all required information is present, click ‘Create’ to:
   • Open the repeating data instance view.
   • Add data to the newly created instance.

 

 

Modern Data Entry (from version 2024.2)

1. In the version 2024.2, click on the Add report button - the exact text of the button will be customized based on your study.

2. A dialog window will appear with the following pre-filled details:
   • Repeating Data: The type of repeating data to be created.
   • Instance Name: A default name will be suggested for the repeating data instance.
     • If the option to edit the custom name is enabled, data entry users can rename the instance.
   • Parent: The parent where the repeating data will be linked.
   • Create the Instance:
     • Once all required information is present, click ‘Create’ to:
       • Open the repeating data instance view.
       • Add data to the newly created instance.

 

Opening a Repeating Data Instance

1. Click on a repeating data instance row to open it. 

 

2. The Overview Panel will collapse, and the Data Entry Panel will slide up. The left-hand side shows the forms in the repeating data instance (for example ‘Event details’ on the screenshot below), functioning similarly to the normal Form Navigator (see: Doing Data Entry).
3. To return to the overview, click All Repeating Data.

 

Managing Repeating Data Instances

Each repeating data instance has a context menu (three dots) with the following options:

• Edit: Opens the dialog window to edit Instance name and Parent.
• Sign this instance: allows signing this instance and its forms.
• Delete: Removes the instance and all associated data. Not available if the study has been set to Live in the past
• Print: print instance.
• Archive:  if the study has been set to Live in the past, archive the instance

 

Showing repeating data instances in the form navigator

1. Show Repeating Data Instances Checkbox:
   • Enables or disables the display of repeating data instances within the Visit/Form Navigator.
   • When selected, repeating data instances (e.g., "Adverse event - 3") appear under their respective Visit (e.g., Adverse Events under First Study Visit as the Adverse event - 3 was attached to the First Study Visit).
   • The option to enable the Show Repeating Data Instances Checkbox in the form navigator can be disabled in the Study settings tab

Data Entry View

 

Modern Data Entry (from 2024.2 version)