View placeholder audit trail
In eTMF, placeholders (also known as "planned documents") are folders or containers that store study documents and records planned to be collected during a clinical trial. With these documents and records, you can evaluate the clinical trial conduct, the integrity and quality of trial data, and compliance of the investigator, sponsor, and monitor with the standards of Good Clinical Practice (GCP) and with all applicable regulatory requirements (ICH Guideline for GCP, E6, Section 8).
In eTMF, you can view the audit trail of existing placeholders; that is, you can track when and how the placeholder was created or modified.
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In the eTMF application header, select the TMF tab.
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On the page that opens, in the left pane, select the Study List subtab.
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In the Study List table, select the needed study name.
Figure 1. Selecting study
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On the page that opens, select the Study Tracking pane option.
Figure 2. Accessing study tracking page
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On the Study Tracking page that opens, switch to the Placeholder tab.
Figure 3. Accessing placeholders
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In the contents panel that opens, locate the needed placeholder. Then from the Action(s) column, select Audit Trail
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In the Audit Trail dialog that appears, view the log of operations performed on the placeholder. Here, you can check what the placeholder name was when it was first created, what study it belongs to, what zone, section, and artifact it has, and when (if ever) it was changed and how.
Figure 4. Viewing placeholder audit trail
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Select
to close the dialog.
Once done, you are redirected to the Placeholder page where you can continue working with your placeholders.