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“Subject Enrollment Complete” action on the study has been run, system-populated with the last subject End of Study or Withdrawn date |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 |