Monitoring Protocol Deviations

Sponsors have the ability to track Protocol Deviations for a Study from within Vault CDMS. You can manually create Protocol Deviations from the Review > Protocol Deviations tab, or the system may create a Protocol Deviation programmatically via a rule. Both manual and programmable protocol deviations are linked to a Subject, Event, Form, or Item, and each protocol deviation captures the following details:

  • Summary
  • Category
  • Subcategory
  • Severity
  • Description
  • Date of Deviation
  • Date Identified

Prerequisites

The Protocol Deviations feature must be enabled for your Study by a study designer.


A study designer must create Categories, Subcategories, and Severities for you to reference when creating Protocol Deviations.


Users with the standard CDMS Clinical Research Associate, CDMS Data Manager, and CDMS Lead Data Manager study roles can perform the actions described below by default. If your organization uses custom Study Roles, then your role must grant the following permissions:

Type Permission Label Controls
Standard Tab Review Tab

Ability to access the Review tab

Standard Tab Protocol Deviations Tab

Ability to access the Protocol Deviations tab

Functional Permission View Protocol Deviations

Ability to view Protocol Deviations

Functional Permission Edit Protocol Deviations

Ability to edit Protocol Deviations

Functional Permission Create Protocol Deviations

Ability to create Protocol Deviations

If your Study contains restricted data, you must have the Restricted Data Access permission to view it.

Learn more about Study Roles.


Viewing Protocol Deviations

Vault displays a Protocol Deviation indicator () on any Subject, Event, Form, or Item that has an associated Protocol Deviation.

Protocol Deviation indicator

You can click the indicator to show a summary of the Protocol Deviation, which includes a link to open the complete view of the Protocol Deviation in the Protocol Deviations tab.

To view a list of all Protocol Deviations, navigate to Review > Protocol Deviations.

Protocol Deviations tab

This opens the Protocol Deviations listing.

Protocol Deviations listing

Searching & Filtering

You can search for individual Protocol Deviations. You can also filter the listing to only show Protocol Deviations in a certain status.

To filter by Protocol Deviation Status:

  1. Navigate to Review > Protocol Deviations.
  2. Click All to open the Protocol Deviation Status filter list.
  3. Select the Statuses that you want to include. Protocol Deviation Status filter list

  4. Click anywhere on the page to leave the filter list.
  5. Open the filter again and either click Clear All or clear individual status checkboxes to remove your filters.

Creating a Manual Protocol Deviation

You can create Protocol Deviations manually, in addition to the programmatic deviations that Vault creates automatically.

On a Subject

To create a Protocol Deviation on a Subject:

  1. Navigate to the Subject in the Review tab.
  2. From the More Actions menu, select Create Protocol Deviation.
  3. In the Create Protocol Deviation dialog, fill the required fields.
  4. Click Save.

On an Event

To create a Protocol Deviation on an Event:

  1. Navigate to the Event in the Review tab.
  2. From the More Actions menu, select Create Protocol Deviation.
  3. In the Create Protocol Deviation dialog, fill the required fields.
  4. Click Save.

On a Form

To create a Protocol Deviation on a Form:

  1. Navigate to the Form in the Review tab.
  2. From the More Actions menu, select Create Protocol Deviation.
  3. In the Create Protocol Deviation dialog, fill the required fields.
  4. Click Save.

On an Item

To create a Protocol Deviation on an Item:

  1. Navigate to the Item in the Review tab.
  2. From the More Actions menu, select Create Protocol Deviation.
  3. In the Create Protocol Deviation dialog, fill the required fields.
  4. Click Save.

Creating Manual Protocol Deviations

Last Updated: 21R2

This video goes over how to create a new, manual Protocol Deviation in the Review tab.

Responding to Protocol Deviations

You can respond to Protocol Deviations by updating the Status, Severity, and Resolution fields in the Sponsor Review section of the Protocol Deviation Details page. What you enter into these fields will depend on your organization’s defined workflow for handling protocol deviations.

To respond to a Protocol Deviation:

  1. Navigate to Review > Protocol Deviations.
  2. Click the Summary to open a Protocol Deviation.
  3. Click Edit.
  4. Update the Status, Severity, and Resolution fields based on your response. Update the Status of a Protocol Deviation

  5. Click Save.

Reviewing Protocol Deviations

Last Updated: 21R2

This video goes over how to review Protocol Deviations in the Review tab.

Exporting Protocol Deviations

You can export a list of all Protocol Deviations as a CSV. Note that any filters you apply to the listing don’t apply to the export.

To export Protocol Deviations:

  1. Navigate to Review > Protocol Deviations.
  2. From the Actions menu, select CSV. Export to CSV

  3. Vault begins generating the CSV file. When finished, Vault sends you an email with a link to download the file.

Viewing the Audit Trail

You can view the Audit Trail for individual Protocol Deviations from the Protocol Deviation Details page. Select Audit Trail from the Actions menu.

Audit Trail action