ABSTRACT

Now that a software application has been chosen for use in clinical data management (CDM), the planning to implement the system begins, that is, putting it into production use. Even the smallest, most contained, of applications cannot be installed and released for use without some forethought and preparation. In some cases, a validation plan by itself will be sufficient. However, any new system that connects (integrates) with other systems and/or requires a migration of existing data would benefit from a separate implementation plan. In this case, the validation plan is just one aspect of the implementation process.