Summary

This article covers the default fields on the configurable deviation form.

Table of Contents

• Add Deviation Form
• Default Fields
  • Date of Deviation Field
  • Site Field
  • Deviation Category Field
  • Specify Other Deviation Category Field
  • Describe the Deviation Field
  • Describe the Action Taken Field
• Save Actions
  • Save Button
  • Cancel Button
• Importing Study Deviations

Deviations for the study are managed through the Deviation form, one of many Configurable Forms. The Deviation form collects the information related to an individual deviation on a study.

Add Deviation Form

The ability to add a new Study Deviation form can be reached by clicking the “Add Deviation” action found in the Actions Menu on the Study Deviation table screen.

Default Fields

The Study Deviation form contains the following fields by default:

Date of Deviation Field

The Date of Deviation field is a date field used to identify the date the deviation occurred. By default, the Date of Deviation field is a preferred field and a red alert will fire if the Date of Deviation data is not provided.

Site Field

The Site field is a multi-dropdown select field used to identify what sites the deviation occurred at. The dropdown contains the option to select all sites listed or unselect all sites.

Deviation Category Field

The Deviation Category field is a dropdown select field used to identify the category of the deviation. By default options include:

• Safety
• Informed Consent
• Eligibility
• Protocol Implementation
• Other

These options can be changed via the Deviation Category Managed List found in CTMS Settings. By default, the Deviation Category field is a preferred field and a red alert will fire if the Deviation Category is not provided.

Specify Other Deviation Category Field

The Specify Other Deviation Category field is a text field used to specify the deviation category when Other is selected.

Describe the Deviation Field

The Describe the Deviation field is a multi-line text field used to describe the deviation. By default, the Describe the Deviation field is a required field and a black alert will fire if the Describe the Deviation data is not provided.

Describe the Action Taken Field

The Describe the Action Taken field is a multi-line text field used to describe the action taken due to the deviation. By default, the Describe the Action Taken field is a preferred field and a red alert will fire if the Describe the Action Taken is not provided.

Save Actions

Save Button

When the Save button is selected the data entered for the questions will be saved and the user will be directed to the Study Deviation table screen.

Cancel Button

When the Cancel button is selected the data entered for the questions will not be saved and the user will be directed to the Study Deviation table screen.

Importing Study Deviations

Primary Identifiers & Required Fields

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