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Monitor template creation

The monitor templates capture the information required to ensure the validity of the clinical trials conducted, such as source data verification, protocol deviations discovered at the site, safety protocols, site qualification, and others. Once you create a monitor template, you can add multiple types of forms to it to capture the required information in your desired format. These forms can include information about the investigator and staff qualifications, facilities and equipment at the site, Institutional Review Board (IRB) regulatory requirements, and so on.

You can create a new monitor template from scratch or by cloning the existing one as explained in the following sections.

Create monitor template from scratch

In CTMS, you can create a custom monitor template and prepare it by adding different types of forms of your choice and adding data (questions) in the forms. This may be useful if the site has unique requirements and there is no monitor template listed in the Monitor Template List table that matches your investigational requirements.

To create a monitor template from scratch

  1. In the CTMS application header, select the LIBRARY tab.

  2. On the page that opens, from the left pane, select the Monitor Template subtab.

    Accessing monitor template subtab
    Figure 1. Accessing monitor template subtab

  3. From the workspace toolbar of the Monitor Template List table, select New Item add_new_icon.png.

    Selecting to create new monitor template
    Figure 2. Selecting to create new monitor template

  4. In the New dialog that appears, add the details as explained in the following table.

    Creating new monitor template
    Figure 3. Creating new monitor template

    Tip

    In the following table, mandatory elements are marked with an asterisk (*).

    Element

    Details

    Template Name*

    Represents the name of the monitor template.

    Create New

    Select this option button to create a monitor template from scratch.

    Clone

    Select this option if you wish to clone an existing monitor template instead of creating a monitor template from scratch, then select this option.

    Need Approve

    Turn the toggle on if you want designated personnel to review and approve your monitor template before you can start using it for a Monitoring Visit in the STUDY MANAGEMENT tab of CTMS.

    Approve By*

    If the Need Approve toggle is turned on, select the user role responsible for approving your configured template.

    Description

    Represents a brief description of the purpose of creating a monitor template.

    SAVE

    Select save_button.png to save your changes.

    CANCEL

    Select cancel_button_white_blue.png to discard your changes and return to the Monitor Template page.

Upon saving, the new monitor template is saved. The template appears in the Monitor Template List table with the Draft phase and an Inactive status.

You can now proceed with adding questions (data) in the template.

See also

Clone existing monitor template

In CTMS, you can create a new monitoring template by cloning and altering the existing one. By cloning the template, you copy all the questions (data) from it and thus, do not need to add it from scratch but rather modify it as required. This may be useful if you want a monitor template for a visit required for a similar (or the same) study but with slightly changed specifications. So using the feature, you can simply clone the existing monitor template created for the study and modify the template slightly for the monitoring visit as per your requirement.

To clone an existing protocol deviation template

  1. In the CTMS application header, select the LIBRARY tab.

  2. On the page that opens, from the left pane, select the Monitor Template subtab.

    Accessing monitor template subtab
    Figure 1. Accessing monitor template subtab

  3. From the workspace toolbar of the Monitor Template List table, select New Item add_new_icon.png.

    Selecting to create new monitor template
    Figure 2. Selecting to create new monitor template

  4. In the New dialog that appears, add the details as explained in the following table.

    Creating clone of existing monitor template
    Figure 3. Creating clone of existing monitor template

    Tip

    In the following table, mandatory elements are marked with an asterisk (*).

    Element

    Details

    Template Name*

    Represents the name of the monitor template.

    Create New

    Select this option if you wish to create a new monitor template from scratch instead of cloning an existing one.

    Clone

    Select this option button to create a monitor template from cloning an existing template.

    Template Name*

    From the dropdown list, select an existing monitor template that you want to clone to the new one.

    Version*

    Represents the latest version of the template you have selected for cloning.

    Need Approve

    Turn the toggle on if you want designated personnel to review and approve your monitor template before you can start using it for a Monitoring Visit in the STUDY MANAGEMENT tab of CTMS.

    Approve By*

    If you have turned the Need Approve toggle on, then in this dropdown, select the person(s) to whom you want to assign the monitor template for review and approval.

    Description

    Represents a brief description of the purpose of creating a monitor template.

    SAVE

    Select save_button.png to save your changes.

    CANCEL

    Select cancel_button_white_blue.png to discard your changes and return to the Monitor Template List page.

Upon saving, the new monitor template is saved, and it appears in the templates listed in the Monitor Template table. You can now proceed with modifying questions (data) in the template.

See also
In this section:

A person who is involved in a clinical trial and is designated to ensure that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation. The clinical investigator must meet requirements set forth by regulatory bodies.

See also: principal investigator

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 monitor template is created for recording the details of a monitoring visit, such as information about the subject's enrollment and retention, source data verification, protocol deviations discovered at the site, and so on. Since the monitoring visit data may vary, to accurately and efficiently capture and record the information, you can create the following types of forms in a monitor template: simple, log, and grid.

The simple and log forms are straightforward and incorporate questions and answers for the reviewer to provide details of their monitoring visit. Grid forms are two-dimensional forms comprising rows and columns that can be used to answer multiple questions for different fields of the same question.