Track study, country and site milestones
Open CTMS > Milestones, choose the Study, Countries (EU) or Sites tab, and click the pencil on a milestone to enter its planned and actual dates. Capture compares them with the plan and flags late items and legal deadlines.
Where to find it
CTMS > Milestones
Before you start
- The CTMS module is switched on.
- To edit study and country milestones you need to be Study Owner, Study Manager, Trial Manager or Administrator. CRAs can edit site milestones for the sites they are assigned to.
Record or correct a milestone date
Open CTMS > Milestones and choose a tab: Study, Countries (EU) or Sites.
On the Sites tab, pick a site with the All sites filter.
Click the pencil next to the milestone.
Enter the Planned date and, once it has happened, the Actual date.
If Capture offers "Records show" a date, click Use this date to take it.
If the milestone has a notification deadline, enter Notified on.
Switch on Not applicable if the milestone does not apply to your study, for example an IND milestone in a non-IND study.
Add Notes, and fill Reason for change if you are changing or clearing a date that was already recorded.
Click Save.
You see "Milestone saved". The change is kept in the audit trail and the status is recalculated.
Which milestones are tracked
| Tab | Milestones |
|---|---|
| Study | IND in effect (FDA), registered on ClinicalTrials.gov, first participant in (FPI), last participant in (LPI), primary completion, last participant last visit (LPLV), database lock, end of trial, results submitted to ClinicalTrials.gov. |
| Countries (EU) | Start of trial in the country, first visit of the first participant, end of recruitment, end of trial in the country. Shown for EU/EEA sites only. |
| Sites | Site selected, IRB / ethics committee approval, Form FDA 1572 collected (US sites), site initiation visit (SIV), site activated, first and last participant enrolled, close-out visit. |
The vs plan column shows On plan, days late or days early. Legal clock shows regulatory deadlines, and red warnings appear under a milestone when dates are out of order, for example "Site activated before IRB / ethics approval".
Common messages
| Message | What to do |
|---|---|
| "Actual date cannot be in the future." | Enter the actual date only once the milestone has happened. Use Planned date for future dates. |
| "Give a reason: a recorded value is being changed or cleared." | Fill Reason for change. Every correction of a recorded date needs one. |
| "Someone else changed this milestone. Reload and try again." | Another person saved first. Reload the page and enter your change again. |
| "...has recorded dates and cannot be deleted. Mark it not applicable instead." | Milestones with dates are never deleted. Switch on Not applicable instead. |
Questions
Where do the "Records show" dates come from?
Capture suggests a date when it already has one in the study, for example the date the first participant was enrolled. A person still confirms it with Use this date.
Can I delete a milestone that does not apply?
Mark it Not applicable instead. Milestones with recorded dates are kept so the history stays complete.
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Please never send participant names, contact details or health information to support.