Creating Planned Studies

The Planned Studies utility allows you to assign general attributes that the clinical studies inherit. These attributes characterize studies at the design level. The Easy Study Design facility writes to a subset of these same database tables; you can modify the planning details of a study that originates in the Easy Study Design facility here.

Before you create a planned study, create affiliations: program, project, organization, and region. (See above.)

To create a new planned study, follow these steps:

1. From the Plan menu, select Planned Studies.
2. Enter a unique study identifier in the Study field of a blank line. If there are no empty rows in the window, use the Insert function. (From the Data menu, select Insert Record, or press F6.) You cannot change this field once you save your work.
3. Complete the Name and Title fields.
4. Assign an organization unit.
5. Assign one region to be the master country: the region that owns the study.
6. Enter the expected number of Investigators.
7. Use the list function to choose a design type. Design type is set in the EXP DESIGN TYPE CODE installation reference codelist.
8. Use the list function to choose a clinical phase. Clinical phase values are contained on the CLINICAL PHASE installation reference codelist.
9. Assign a program.
10. Assign a project. To modify the planning details of an existing study, select the appropriate field.