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Protocol deviation template

The protocol deviation occurs when there is an unintended and unexpected divergence from the expected or Institutional Review Board (IRB)-approved protocol. The deviation can occur due to multiple reasons, such as a subject missing their visit, enrolling a participant who did not meet all the inclusion/exclusion criteria, failing to perform a required lab test, and so on.

Using the functionality of the Protocol Deviation Template subtab, you can create a template to acquire the details of the occurrence of protocol deviation, like date of occurrence, deviation description, action taken by the site, whether the occurrence is reported to IRB, details of the reviewer, and others. These templates can then be associated with a study, site, or subject in the STUDY MANAGEMENT > Study > Protocol Deviation > PD Setting functionality of CTMS.

Protocol deviation template
Figure 1. Protocol deviation template

On the Protocol Deviation Template page, the PD Template List table lists all the templates created. The elements of this table are explained in the following table.

Element

Details

Template Name

Represents the name of the template.

Version

Represents the latest version of the template.

Phase

Represents phases of the template which can be any of the following:

  • Draft: represents that the template is currently being edited and the data (questions) are being updated in the template. The template is in the Draft phase when it is created and remains unchanged until it is submitted.

  • Auditing: represents that the template has been submitted for the assigned reviewer's approval and awaits resolution.

  • Final: represents that the template is approved (if it required approval) and has been successfully created. The template is now ready for use.

Status

Represents the status of the protocol deviation template which can be active or inactive. Only an active template can be assigned to a site, study, or subject.

Description

Represents a brief description of a template informing readers about why the template is created.

In the Protocol Deviation Template subtab, you can perform the following actions:

In this section:

Also known as an Independent Ethics Committee (IEC) in the European Union, the Institutional Review Board is a group that is formulated and formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research.

A divergence from the IRB or sponsor-approved study design or procedures defined in the protocol, consent document, or study materials. The deviation can occur due to multiple reasons, such as a subject missing their visit, enrolling a participant who did not meet all the inclusion criteria, failing to perform a required lab test, and so on.