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Import/Export 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 this functionality, you can import or export the protocol deviation records into or from the system.

Importing can be useful if you want to add multiple records at once and do not want to configure them individually. Thus, you can download the protocol deviation record template, fill it out, and import it into the system.

Also, you can export the existing protocol deviation records from the system to your computer, for instance, if you want to work with them offline for some analysis purposes.

To import or export the protocol deviation record(s)

  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 one of the following options:

    1. Import import_icon.png: select this option to import the XLSX file with the protocol deviation record from your computer.

    2. Export export_icon.png: select this option and then one of the following:

      1. Export All: select this option to export the entire protocol deviation record list for study, site, and subject levels.

      2. Export Current Level: select this option to export only the records of the currently selected tab and respective level(s).

    Importing/Exporting PD record
    Figure 4. Importing/Exporting PD record

Based on your action, new protocol deviation record(s) are imported to the CTMS application, or the existing records are exported from the application to your computer.

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.