Create a study plan

Create a new, unique study plan when you want to specify all plan attributes.

Note:

To complete this task, you must have a business role permission that allows you to access Study Planning

  1. In the left navigation panel, click Plan study (Icon is a plus sign inside a circle).
  2. In the Plan a new study modal, enter a study plan name and click Save and Continue.
  3. On the General specs (Plan study) page, add entries for the required Version Reason, Therapeutic Area, Planning Version, and Phase fields. All other fields are optional.
  4. Click Save and Continue.
  5. On the Countries & Sites page, choose the number of countries from the drop-down list. For each country row:
    1. Use the Select Country drop-down list to select the country name
    2. Enter the number of Sites.
    3. Click Site Characteristics. On the Site Characteristics modal, enter the country’s site Central or Local IRB/EC distributions, and click Save.
  6. Click Save and Continue.
  7. On the Dates page, select the preferred event for Prediction start date event (i.e., Final approved Protocol, Essential docs sent to sites) and enter the preferred start date.
  8. Select dates for each milestone in the Projection start date section and click Save and Continue.
  9. On the View and Manage Milestone Probabilities page, adjust the summary milestones as preferred using the drop-down list.
  10. Click Save and Continue.
  11. The plan output page displays. Click Save and Exit to save the plan.