Introduction

The Clinical Data module integrates

• subject enrollment, 
• electronic data capture and 
• clinical data management features. 

Subject enrollment includes registration, and can include other activities, such as randomization, defined as enrollment activities. The system tests inclusion and exclusion criteria, performs dynamic eligibility checks and facilitates protocol deviation managementdeviation management.

Real time edit checks are run at time of data input and automatic queries are generated at time of submission of the case report forms. Conditional triggering of data and a dynamic study flow (activities based on protocol visits/assessments) facilitate data input and improves the completeness of the submitted data.

Electronic signatures are collected both for the clinical data as well as for the activities. All changes applied to the clinical data by any of the users are tracked and documented in the audit trail which is accessible at several levels.