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Create monitoring plan

A monitoring plan refers to a comprehensive strategy that outlines how sites of a clinical trial are to be monitored for compliance, quality, and safety. You can create as many new monitoring plan entities as needed. Based on every created monitoring plan, monitoring visits will be generated by the system according to the preset schedule. Since there must be a dedicated personnel in charge of each monitoring visit generated according to the established monitoring plan, you need to add human resources first before creating a monitoring plan.

To create a monitoring plan entity

  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 that opens, in the left pane, expand Monitoring and select Monitoring Plan.

  3. Above the Monitoring Plan table that appears, on the workspace toolbar, select New Item add_new_icon.png.

    Accessing monitoring plans
    Figure 3. Accessing monitoring plans

  4. On the page that opens, complete the form as suggested in the following table.

    Creating monitoring plan
    Figure 4. Creating monitoring plan

    Tip

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

    Element

    Details

    Monitoring Plan

    Monitoring Type*

    Select the type of monitoring for the created monitoring plan.

    Monitoring Method*

    Select the method of monitoring for the created monitoring plan.

    Site Code*

    Select sites for which the created monitoring plan is designed. You can also apply this plan to all sites at once.

    Periodical Visit*

    Define whether the monitoring visits need to occur periodically with the outlined frequency or not.

    Planned Start Date*

    Select the date when the monitoring plan needs to be initiated.

    Planned End Date*

    Select the date when the implementation of the monitoring plan is to finish.

    Trip Report Template Name*

    Select the monitor template according to which trip reports for visits of the created plan are to be generated.

    Number of Monitoring Visits*

    Enter here a number of monitoring visits that need to take place according to the created monitoring plan.

    You can select a number value here only if No is selected in the Periodical Visit field.

    Frequency

    Select here a frequency with what monitoring visits need to be populated based on the created monitoring plan.

    You can select a frequency only if Yes has been selected in the Periodical Visit field.

    For example, you can select the monitoring visits to be generated every Tuesday of the week or every second Monday of the month.

    Monitoring Content

    Category

    After selecting a monitoring type, a list of category items is populated according to the selected type. You can update these values manually depending on the monitoring plan requirements.

    Content

    After selecting a monitoring type, the content is populated according to the selected type and content category. You can update these values manually depending on the monitoring plan requirements.

    Add Content

    Select plus_icon.png to add a new item to the monitoring plan content. You can then add its category and content message manually.

    Remove

    Select minus_circled_icon.png to remove an item from the monitoring plan content.

    Library

    Select reference_item_icon.png to open the library of monitoring plan content items. You can clear the selection for those that you want to remove from the list of monitoring plan content or select some of them to add, respectively.

    SAVE

    Select save_button.png to save the created monitoring plan entity.

Once saved, the monitoring plan entity is created. You can now proceed to creating a monitoring visit.

In this section:

In a clinical trial, a location where the subject treatment and drug dispensation occur. It can be a hospital, a private laboratory, or other institutions.

A document that summarizes the activities, observations, and findings of a monitoring visit conducted by a clinical research associate (CRA) or a monitor at a clinical trial site. The purpose of a trip report is to provide a detailed account of the visit, including the review of study data, source documents, regulatory compliance, and overall study conduct.