Complete tracking log entry
After adding the tracking log setting, you can start completing the log entries to maintain a clear record of regulatory documents and their submissions, approvals, and updates throughout the clinical trial. Tracking logs support compliance, audit readiness, and effective oversight across all study sites.
The tracking log entries can be added from scratch and completed right away or presaved and completed later. Another scenario is that the entry is created automatically by the system based on the configuration to autofetch data to the tracking log. The autocreated entries have the Initial status until manually completed.
Important
Note that you can only complete the tracking log if you have been granted the write permission for the corresponding log.
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Access the study management page in one of the following ways:
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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
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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
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On the page that opens, from the left pane, select Tracking Log. Then from the expanded menu, select the name of the previously added tracking log.
Figure 3. Accessing tracking log
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On the page that opens, do one the following:
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In the single-form tracking log, based on the level of the tracking log selected upon setting, the Site, Study, or both tabs are available. Select the needed tab to access the entry list.
Figure 4. Selecting tab to access entry list
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In the multiform tracking log, select the needed form to access the entry list.
Figure 5. Selecting form to access entry list
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On the resulting page with the tracking log entry list, do one of the following:
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To add a new tracking log entry, from the workspace toolbar, select New Item
.
Figure 6. Selecting to add tracking log entry
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To review and complete the system-created tracking log entry, select the needed form and then next to the log entry you need, select Go
.
Figure 7. Accessing autocreated tracking log entry to complete
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In the form that appears, enter the details of the tracking log entry from scratch or review the existing details autofilled by the system and enter the missing data.
Tip
The fields of the forms vary based on the template selected upon tracking log setting and the level of the tracking log—study or site.
The site-specific data, such as PI name, site name, and so on can be autopopulated based on the selected site code; these details are pulled from the site profile.
Figure 8. Completing tracking log
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Once the form is initiated or completed, there are a few actions available to you as explained in the following table.
Action
Details
SAVE
Select
to save and submit the completed form.Temp Save
Select
to save the changes if the form is not entirely completed or requires further details. Thus, the form remains in the Initial status until completed.Inactivate
Select
to deactivate the tracking log entry. Inactive records cannot be completed or otherwise maintained.For deactivation, you must provide the reason.
Figure 9. Providing deactivation reason
Activate
Select
to activate the previously deactivated tracking log entry. For activation, you must provide the reason.
Figure 10. Providing activation reason
Once saved, the tracking log entry form is submitted and completed. The dialog appears for you to choose the next action—go to the record list, open a new empty form for another record, or select CANCEL to stay on the current record page.
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