Generate a Summary of Changes
TrialPath | Study Sign Off
If a study has more than one protocol version, you can create a Summary of Changes that lists changes from one protocol version to another. This enables you to quickly identify changes, review protocol amendments, and compare protocol versions.
Generate a summary of changes between any two study protocol versions
If a study has more than one protocol version, you can create a Summary of Changes Excel file that lists changes to activities, eligibility criteria, events, visits, and visit activities from one protocol version to another, regardless of whether automatic migration is supported.
To generate a summary of changes:
Under Studies, search for and select a study name.
Go to the Schedule of Events tab.
At the top left, select the Protocol Version.
At the top right, click Generate Summary of Changes.
On the pop-up window, select the protocol version to compare to the version selected above, and then click Generate Summary of Changes.
Review the Summary of Changes
Open the downloaded file name to open the spreadsheet.
The Summary of Changes spreadsheet contains tabs to show changes for Activities, Eligibility Criteria, Events, Visits, and Visit Activities. Select a tab to see a list of changes to the selected protocol version.
