Track site readiness before activation
Open CTMS > Site readiness to see each site's start-up checklist. Record each item with its date and document reference; a site can only be activated once every required item is done.
Where to find it
CTMS > Site readiness
Before you start
- The CTMS module is switched on and the site exists in Settings > Sites.
- Study Owners, Study Managers and Administrators can update any site. CRAs can update the sites they are assigned to.
Record a checklist item
Open CTMS > Site readiness and pick the site.
The badge shows "Ready to activate", "Active since" a date, or how many required items are still open.
Click the pencil next to the item.
Choose Done, Not done or Not applicable.
Not applicable is not offered for the four items that always gate activation.
For Done, enter the Date and, where it applies, Expires on.
Enter a Document reference, for example the letter number and where it is filed.
Fill Reason for change if you are changing a recorded value, then click Save.
You see "Checklist item saved". Readiness and the milestone suggestions update straight away.
What the checklist contains
Four items always gate activation: IRB/EC approved, Contract executed, Site initiated / SIV completed and Delegation log complete. Seven more can be made required: approved consent form on file, Form FDA 1572 signed (US sites), investigator CVs and licences, financial disclosure, staff GCP and protocol training, lab certification and normal ranges, and an insurance certificate (EU/EEA sites).
Status labels are Done, Missing, Expired, Expires soon (within 30 days), Not applicable and Not for this country.
Choose which items are required before activation
On Site readiness, find the card Required before activation.
Switch on an optional item to require it. It applies immediately.
To stop requiring an item, switch it off, fill Reason (required) and click Stop requiring.
Questions
Why can a CRA not change which items are required?
Only people who manage sites (Study Owner, Study Manager, Administrator) decide what gates activation. CRAs record the items themselves for their own sites.
What happens when a document expires?
The item turns Expires soon 30 days before the expiry date and Expired after it, and the site shows in the warnings on Trial overview.
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