Who can complete this task?
  • Clinical Basics: CTMS Vault Admin, Clinical Basics: Study Manager, Clinical Basics: Monitor

Milestones play a key part in driving the efficiency and timeliness of a study. Typically, the Study Manager will be responsible to record the planned dates, while the Monitor will be responsible to record certain actual dates.

Milestones dates are recorded throughout the study and should be kept up to date. They are typically planned and tracked at the Study level and the Site level, but can also be planned and tracked at the Country level as well.

Study Milestones

  Study Milestone When to Record the Planned Date How the Actual Date is Recorded
01 Study Start When Protocol is approved Recorded manually after the Study starts
02 First Study Site Initiated When Site Initiation Visit is planned for first site Recorded manually after first site is activated
03 First Study Subject In When first site is activated and the enrollment plan is finalized System-populated with the earliest subject Enrolled date
04 First Study Subject Treated When first site is activated and the enrollment plan is finalized System-populated with the earliest subject Started Treatment date
05 First Study Subject Out When first site is activated and the enrollment plan is finalized System-populated with the earliest subject End of Study date
06 Last Study Subject In When last site activated and enrollment plan finalized Once the “Subject Enrollment Complete” action on the study has been run, system-populated with the last subject Enrolled date
07 Last Study Subject Treated When last site activated and enrollment plan finalized Once the “Subject Enrollment Complete” action on the study has been run, system-populated with the last subject Ended Treatment date
08 Last Study Subject Out When last site activated and enrollment plan finalized Once the “Subject Enrollment Complete” action on the study has been run, system-populated with the last subject End of Study or Withdrawn date
09 Database Lock When the last site is closed Recorded manually once Database Lock is achieved
10 Study Close When Database Lock is achieved Recorded manually once the Study is closed

Site Milestones

  Site Milestone When to Record the Planned Date How the Actual Date is Recorded
01 Site Selected When the Pre Study Visit is planned Recorded manually after a successful Pre Study Visit
02 Ready to Enroll When the Site Initiation Visit is planned Recorded manually after the Site Initiation Visit
03 First Subject In After the Site Initiation Visit is complete System-populated with the earliest subject Enrolled date
04 First Subject Treated After the Site Initiation Visit is complete System-populated with the earliest subject Started Treatment date
05 First Subject Out After the Site Initiation Visit is complete System-populated with the earliest subject End of Study date
06 Last Subject In After the Site Initiation Visit is complete Once the “Subject Enrollment Complete” action on the study has been run, system-populated with the last subject Enrolled date
07 Last Subject Treated After the Site Initiation Visit is complete Once the “Run the Enrollment Completion” action on the study has been run, system-populated with the last subject Ended Treatment date
08 Last Subject Out After the Site Initiation Visit is complete Once the “Subject Enrollment Complete” action on the study has been run, system-populated with the last subject End of Study or Withdrawn date
09 Site Closed When the Close Out Visit is planned Recorded manually after the Close Out Visit