Activity management in study
An activity in a clinical trial refers to a specific task, process, or event that must be completed as part of the study workflow. Activities play a crucial role in study execution, tracking, and compliance, ensuring that each phase progresses according to the protocol and regulatory requirements.
After activities are defined and pushed to the study, you can manage the activities in your study. This involves tracking, updating, and monitoring key study events after execution. Effective activity management ensures adherence to study timelines, helps identify potential delays, and supports the efficient completion of critical study phases.
In the following sections, you can learn about various features available to manage the activities in the study.
An activity in a clinical trial represents a specific task or process that must be completed as part of the study workflow. Activities can include tasks like patient screening, drug dispensation, data collection, site monitoring, and so on. After the activity is executed to the study, its details can be updated as needed. This may involve modifying scheduling parameters, such as start and end dates, frequency of execution, and other relevant details to ensure accurate study management.
-
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.
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.
Figure 2. Accessing study management from study data list
-
-
In the left pane, select Project Management > Master Activities.
-
Above the Master Activity List table, select one of the following options:
-
Study Level: activities represent major phases that impact the overall study, such as study protocol approval, ethics committee approvals, and so on.
-
Country/Region Level: activities focus to a particular country or region within the study, like country-specific regulatory approvals, import or export permits for study drugs, and others.
-
Site Level: activities conducted at individual trial sites where study activities take place, such as patient screening and enrollment, drug dispensation and administration, site monitoring visits, and others.
-
-
In the Master Activity List table, either select the required activity's name or next to it, from the Action(s) column, select Edit
.
Figure 3. Accessing options to edit activity
-
In the Project Details panel that opens, update the activity details as explained in the following table.
Figure 4. Updating activity details
Tip
In the following table, mandatory elements are marked with an asterisk (*).
Element
Details
Planned Start Date*
Select the date picker
to specify the scheduled start date for the activity.Planned End Date*
Select the date picker
to specify the actual date when the activity began.Actual Start Date*
Select the date picker
to specify the expected completion date for the activity.Actual End Date*
Select the date picker
to specify the actual date when the activity was completed.This field is mandatory only if the Status of the activity is Completed.Duration Days*
Enter the total duration (in days) from the start to the end of the activity.
Status*
Select the current state of the activity: Not Started, Ongoing, or Completed.
Assign to Role
Select the user role to which you want to assign the activity, such as investigator, coordinator, and others.
Activity Type
Select the type or category of the activity defined in the Activity Types feature.
Periodical Activity
Select Yes if the activity recurs periodically, otherwise, select No.
For example, if the activity (such as patient monitoring or data collection) needs to be performed weekly or monthly, this setting ensures that the activity is scheduled to occur at those intervals instead of being a one-time event.
Frequency
If you select Yes in the previous Periodical Activity field, then here specify when is the activity expected to recur by choosing one of the following options:
Pre Activities
Define dependencies between activities by specifying pre-activities and their timing before executing the main activity.
Select Add Content
to start defining the pre-activity as follows:-
In the first field that appears, from the dropdown list, select an activity existing at the study, country or region, or site level as a prerequisite.
-
Then, select the type of relationship between activities, such as Start - Start means that the pre-activity starts as soon as the main activity starts.
-
Lastly, specify the number of days before the main activity should start after the pre-activity is completed.
Post Activities
Displays any post-activities associated with the activity. These activities occur after a primary trial activity is completed, such as Distribution of CRFs or eSource Document occurs after data collection or an investigative procedure is completed.
SAVE
Select
to save your changes and update the activity details.CANCEL
Select
to dismiss your changes without saving. -
Once saved, the activity is updated and can be seamlessly used to keep track of the study timeline.
An activity in a clinical trial represents a specific task or process that must be completed as part of the study workflow. Activities can include tasks like patient screening, drug dispensation, data collection, site monitoring, and so on. If required, you can activate or inactivate the activity to control its availability within the study. This helps manage study tasks by enabling or pausing activities as needed.
-
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.
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.
Figure 2. Accessing study management from study data list
-
-
In the left pane, select Project Management > Master Activities.
-
Above the Master Activity List table, select one of the following options:
-
Study Level: activities represent major phases that impact the overall study, such as study protocol approval, ethics committee approvals, and so on.
-
Country/Region Level: activities focus to a particular country or region within the study, like country-specific regulatory approvals, import or export permits for study drugs, and others.
-
Site Level: activities conducted at individual trial sites where study activities take place, such as patient screening and enrollment, drug dispensation and administration, site monitoring visits, and others.
-
-
In the Master Activity List table, do one of the following:
Activate or inactivate multiple activities at once by selecting the required activities from the table. From the workspace toolbar, select More
> Activate 
or Inactivate 
.
Figure 3. Inactivating multiple activities
Important
You can perform this action in bulk only if all selected activities share the same current status. If all selected activities are active, you can inactivate them, and if they are inactive, you can activate them. However, if the selection includes both active and inactive activities, the Activate
or Inactivate action is not available. -
In the Reason dialog that appears, enter the reason for activating or inactivating the activity. Then, select SAVE.
Figure 5. Entering reason to inactivate activity
Once saved, the activities are activated or inactivated.
An activity in a clinical trial represents a specific task or process that must be completed as part of the study workflow. Activities can include tasks like patient screening, drug dispensation, data collection, site monitoring, and so on. If required, you can delete an activity if it is no longer required.
-
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.
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.
Figure 2. Accessing study management from study data list
-
-
In the left pane, select Project Management > Master Activities.
-
Above the Master Activity List table, select one of the following options:
-
Study Level: activities represent major phases that impact the overall study, such as study protocol approval, ethics committee approvals, and so on.
-
Country/Region Level: activities focus to a particular country or region within the study, like country-specific regulatory approvals, import or export permits for study drugs, and others.
-
Site Level: activities conducted at individual trial sites where study activities take place, such as patient screening and enrollment, drug dispensation and administration, site monitoring visits, and others.
-
-
In the Master Activity List table, do one of the following:
-
In the Reason dialog that opens, describe the reason for deleting the activity. Then, select SAVE.
Figure 5. Entering reason to delete activity
Once saved, the activities are deleted from the system.
An activity in a clinical trial represents a specific task or process that must be completed as part of the study workflow. Activities can include tasks like patient screening, drug dispensation, data collection, site monitoring, and so on. If needed, you can view a detailed log of all actions performed on the activity that ensures transparency and helps you track changes over time. By reviewing the operation history, you can verify what and by whom the modifications were introduced and when, helping with compliance, auditing, and troubleshooting.
-
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.
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.
Figure 2. Accessing study management from study data list
-
-
In the left pane, select Project Management > Master Activities.
-
Above the Master Activity List table, select one of the following options:
-
Study Level: activities represent major phases that impact the overall study, such as study protocol approval, ethics committee approvals, and so on.
-
Country/Region Level: activities focus to a particular country or region within the study, like country-specific regulatory approvals, import or export permits for study drugs, and others.
-
Site Level: activities conducted at individual trial sites where study activities take place, such as patient screening and enrollment, drug dispensation and administration, site monitoring visits, and others.
-
-
In the Master Activity List table, next to the required activity, from the Action(s) column, select More
> Operation History 
.
Figure 3. Accessing operation history of activity in study
-
In the Operation History dialog that opens, view the list of user actions that have been performed with the selected activity.
Figure 4. Viewing operation history of activity in study
Once viewed, select CLOSE to return to the table displaying activities.
An activity in a clinical trial represents a specific task or process that must be completed as part of the study workflow. Activities can include tasks like patient screening, drug dispensation, data collection, site monitoring, and so on. If required, you can export the activities to generate and download activity data for reporting, analysis, or documentation purposes.
-
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.
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.
Figure 2. Accessing study management from study data list
-
-
In the left pane, select Project Management > Master Activities.
-
Above the Master Activity List table, select one of the following options:
-
Study Level: activities represent major phases that impact the overall study, such as study protocol approval, ethics committee approvals, and so on.
-
Country/Region Level: activities focus to a particular country or region within the study, like country-specific regulatory approvals, import or export permits for study drugs, and others.
-
Site Level: activities conducted at individual trial sites where study activities take place, such as patient screening and enrollment, drug dispensation and administration, site monitoring visits, and others.
-
-
In the Master Activity List table, from the workspace toolbar, select Export
and then choose of the following options:-
Export All: to export all the activities existing in the study, country or region, and site.
-
Export Current Level: to export the activities existing on the selected level.
Figure 3. Exporting study activities
-
-
The download widget appears showing the export progress. Select the widget to access exported files.
Figure 4. Download widget showing study activities being exported
-
In the My Downloads dialog that appears, in the Download is Ready tab, select
next to the required exported file.
Figure 5. Downloading list of study activities
Once selected, the list of study activities is downloaded as an XLSX file to your computer.