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Managing Patient Unenrollment Reasons

Patient Unenrollment Reasons appear as an optional selection when inactivating a patient/subject on a protocol. Clients have the option to add more reasons as required, and limited modifications are allowed to the standard reasons.

Vestigo includes a set of standard Patient/Subject Unenrollment Reasons that can be used when unenrolling patients/subjects from a protocol. The reasons are visible on the Patient Enrollment History report.

  1. Add an Unenrollment Reason
  2. Modify an Unenrollment Reason
  3. Inactivate an Unenrollment Reason
  4. Reactivating an Unenrollment Reason
  5. Deleting an Unenrollment Reason

Permissions Needed

AdminMain – Access the application administrative menu

EditClientandFacilitySettings - Along with App Admin, this permission should enable/disable the "Edit Client and Facility Settings" page

PatientUnenrollment Reasons - Application Administration > Edit Client and Facility Settings > Patient Unenrollment Reasons. Ability to manage Patient Unenrollment Reasons

Standard Vestigo Patient/Subject Unenrollment Reasons

Vestigo provides these reasons roles for every client. The reason names cannot be modified by site users, but they can be inactivated.

Progressive Disease
AE/Unacceptable Toxicity
Withdrew Consent/Follow Up
Death on Study
Lost to Further Follow Up
Compliance Issues
Physician's Decision
Serious Adverse Event
Protocol Closed
Unenrolled from Protocol
Treatment Completed

 

Adding a Patient/Subject Unenrollment Reason

  1. Navigate to Application Administration
  2. Click on Edit and Client Facility Settings
  3. Click on Patient Unenrollment Reasons under Client Settings on the right side
  4. Click on Add New
  5. Enter the description of the new Patient Unenrollment Reason
  6. Leave the Is Active flag checked
  7. Click Save

 

Editing a Patient/Subject Unenrollment Reason

Site users have limited modification ability on system generated roles and are limited to deactivating them. System generated reason names cannot be edited. 

Once a site has used a site created reason, you can no longer edit the reason name.

  1. Navigate to Application Administration
  2. Click on Edit and Client Facility Settings
  3. Click on Patient Unenrollment Reasons under Client Settings on the right side
  4. Click on Edit for the reason you wish to edit
  5. Make the appropriate modifications to the role as needed
  6. Click Save

 

Inactivating a Patient/Subject Unenrollment Reason

Inactivating a patient unenrollment reason does not impact historical information but will prevent users from being able to use the reason on future unenrollment's.

  1. Navigate to Application Administration
  2. Click on Edit and Client Facility Settings
  3. Click on Patient Unenrollment Reasons under Client Settings on the right side
  4. Click on Deactivate for the reason you wish to inactivate
  5. Click Ok to confirm the modification

 

Reactivating a Patient/Subject Unenrollment Reason

  1. Navigate to Application Administration
  2. Click on Edit and Client Facility Settings
  3. Click on Patient Unenrollment Reasons under Client Settings on the right side
  4. Click on Activate for the reason you wish to reactivate
  5. Click Ok to confirm the modification

 

Deleting a Patient/Subject Unenrollment Reason

Site users can delete a reason, if the reason has never been used. If the reason has been used, you can only inactivate the reason.

  1. Navigate to Application Administration
  2. Click on Edit and Client Facility Settings
  3. Click on Patient Unenrollment Reasons under Client Settings on the right side
  4. Click on Delete for the reason you wish to delete
  5. Click Ok to confirm the modification