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Activate/Inactivate protocol deviation record

In CTMS, whenever a protocol deviation occurs, you can record it by using a protocol deviation template. Recording a deviation is necessary for avoiding such deviation from occurring in the future, or it can be a requirement of the sponsor as well.

While you are creating a record of a protocol deviation, under some circumstances, you may require to inactivate it.

For example, you are not sure about the occurrence of a deviation, or there is some data missing, or the study to which the deviation belongs is discontinued, or else. In such a situation, you can inactivate a record and later, if the circumstances change, you can activate the record again.

To inactivate or activate a protocol deviation record

  1. Access the study management page in one of the following ways:

    • In the CTMS application header, select the DASHBOARD tab and then select the study dashboard of your interest.

      Accessing study management from dashboard
      Figure 1. Accessing study management from dashboard

    • In the CTMS application header, select the STUDY MANAGEMENT tab. Then from the Study Data List table, select the study name of your interest.

      Accessing study management from study data list
      Figure 2. Accessing study management from study data list

  2. On the study page, in the left pane, expand Protocol Deviation and select Protocol Deviation Record.

  3. On the page that opens, from the content panel, select the needed tab.

    Accessing protocol deviation records
    Figure 3. Accessing protocol deviation records

    Tip

    If the same protocol deviation template is associated with two or more entities—study, site, or subject—they are displayed in a single tab named through a slash, such as Study/Site, Study/Site/Subject, or else. Whereas, the entities associated with unique template forms are displayed in separate tabs, such as Study, Site, or Subject.

  4. In the table, locate the record you want to activate or inactivate and next to it, from the Actions column, select Activate activate_icon.png or Inactivate inactivate_icon.png, respectively.

    Activating/Inactivating deviation record
    Figure 4. Activating/Inactivating deviation record

    Alternatively, next to the record you want to activate or inactivate, from the Actions column, select Go go_icon.png. Then on the form page that opens, from the workspace toolbar, select activate_button.png or inactivate_button.png, respectively.

    Activating/Inactivating deviation record from form page
    Figure 5. Activating/Inactivating deviation record from form page

  5. In the Reason dialog that appears, enter the reason explaining why you are inactivating an active or activating an inactive record.

    Entering reason for inactivating record
    Figure 6. Entering reason for inactivating record

  6. Select save_button.png.

Once saved, depending on the performed action, the protocol deviation is inactivated or activated.

In this section:

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.

Any person, company, institution, group, or organization that is a client of EDETEK and a user of the eClinical system.

In the eClinical system, the Sponsor role is assigned to the user who oversees or pays for a clinical trial and collects and analyzes the data. Before the study goes live, the Sponsor users work closely with the data managers, configuring CRFs and other aspects to make sure everything meets their requirements before giving the green light for the study to go live. In the course of a trial, the Sponsor users make requests for amendments in the system according to a new protocol version, changes in business requirements, or other needs.