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View audit trail on 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.

Using the auditing functionality, you can view the changes done to the specific information added to the record. This may be necessary if you want to view who added a certain piece of information to the record, if there were any opened queries, what was the response to the query, and so on.

To view the audit trail on the protocol deviation record items

  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 that has the Completed status, and next to it, from the Actions column, select Go go_icon.png.

    Accessing completed PD record form
    Figure 4. Accessing completed PD record form

  5. In the record form that opens, locate the question or data item for which you want to view the operation history.

  6. Next to the needed data item, from the Actions column, select arrow_down_expand_collapse_gray.jpg > Audit Trail history_icon.png.

    Selecting option to view operation history
    Figure 5. Selecting option to view operation history

  7. In the Audit Trail dialog that appears, view the information as explained in the following table.

    Entering query details
    Figure 6. Entering query details

    Element

    Details

    Audit

    Represents the particular action performed on the information item.

    User

    Represents the user who performed the action.

    Time

    Represents the date and time at which the action is performed.

    OK

    Select OK_button_red.png to close the dialog.

Once closed, you are redirected to the record form. You can select Back move_left_icon.png to return to the Record page.

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.