Mark fields and visits/forms as missing in CDMS

In clinical data collection, there are scenarios where data points cannot be entered due to specific reasons.  The Mark as Missing feature allows users to indicate and document such cases systematically, ensuring compliance with Good Clinical Practice (GCP).

Marking a Field as Missing

To mark a field as missing, follow the steps below:

1. Click the 3 dot menu next to the field.
2. Select the Mark field as missing value from the dropdown menu.
   
   
   
   
3. A dialog window will appear prompting you to select a reason for the missing data.
   • Available reasons include:
     • Measurement failed (-95)
     • Not applicable (-96)
     • Not asked (-97)
     • Asked but unknown (-98)
     • Not done (-99)
4. Add a Comment (Optional): Enter additional details in the comment box to explain the missing data further.
5. Click Save to finalize the action.

A few observations:

1. The field will appear faded/greyed out in the form.
2. The status icon will update to indicate the field is complete.
3. A comment will be attached to the field, recording the reason for the missing value.

Removing the Missing Status from a Field

If the missing status needs to be removed:

1. Click the cogwheel icon next to the field.
2. Select.
   
   

3. The missing status will be removed, and the field will allow new data entry.
4. The comment associated with the previous missing status will remain, and all actions will be logged in the audit trail.

For the 2024.2 and later versions, follow the steps below to remove the missing status:

1. Click the context menu (three dots) next to the field.
2. Choose the Unmark field as missing value option.

3. The missing status will be removed, and the field will allow new data entry. 
4. The comment associated with the previous missing status will remain, and all actions will be logged in the audit trail.

Marking a Full Form or Visit as Missing

Entire forms or visits can also be marked as missing when no data can be collected.

1. Locate the form or visit in the form navigator.
2. Click the 3 dot menu next to the form or visit name.
3. From the dropdown menu, choose ‘Mark visit/form as missing’.
   
   

4. In the dialog window, select a reason for marking the form/visit as missing.
5. Add a comment if necessary.
6. Click Save to finalize the action.

Marking a visit as missing cannot be undone and may affect signatures, verifications and dependencies related to the visit. Proceed with caution.

Repeating Data Instances

• For repeating data instances, only individual fields within the instance can be marked as missing.
• The entire repeating data instance cannot be marked as missing.

Key Considerations

• Audit Trail: Every action related to marking fields, forms, or visits as missing is logged for compliance and traceability.
• Grid Fields: Note that grid fields cannot be marked as missing.
• Exported Data: The reason for missing data will be assigned as the value for the field and included in data exports.