Introduction

The Clinical Data module integrates

subject enrollment,
electronic data capture (eCRFs),
study flow (activities) and,
signature studio (e-signatures).

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 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 improve 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.

Studies overview

The Clinical Data module start page provides an overview of all the studies to which the user has access according to his/her account. The overview lists the identification of the study, the status of the study (e.g. active for registration) and the number of subjects enrolled per study.

In a second tab 'Protocol Deviations' the user can manage the protocol deviations for which he/she is responsible.

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