Skip to main content

Download protocol deviation record template

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 this functionality, you can download the template of protocol deviation records. This may be necessary if you want to import multiple protocol deviation records to the system at once. The template helps you follow the record structure compatible with the system requirements. Once you add the protocol deviation details to the template, you can easily import the records to CTMS.

To download the protocol deviation record template

  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. From the workspace toolbar of the page that opens, select Download Template download_template_icon.png.

    Downloading PD record template
    Figure 4. Downloading PD record template

Once selected, the protocol deviation record template file is downloaded to your computer in the XLSX format.

In the template file, the first sheet displays the index showing basic details of the file, such as the study name, the user who exported the file, and so on. The rest of the sheets in the template file correspond to the tabs displayed on the Record page. You can now complete the template with records and reupload it to CTMS.

Completing PD record template file
Figure 5. Completing PD record template file

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.