9.3.2       Trial (Study) Change Workflow

The trial change workflow is as follows:

1.      Client analyzes the trial protocol to create trial change specifications.

2.     A database back-up of the trial is imported into AnjuEDC.

3.      Mid-Study Changes (MSCs) are made to the trial. (See the MSC Workflow diagram.)

4.     The trial is completed by the client in TrialMaster.