Contents

Introduction

Study Flow

The study flow in the Clinical Data module shows the pathway of activities a patient follows during a trial and dynamically triggers the corresponding clinical data to be completed. The flow is always initiated by the registration of the patient followed by the activities as defined by the protocol. This section consists of a summary table listing the activities, followed by a graphic study flow highlighting the patient specific pathway.

Activity

An activity is a step in a subject’s possible path from accrual to end of study. The initiation of an activity (automatically or by the user) causes the correct eCRFs to be triggered in the data section of the Clinical Data module.

There are several types of activities, which type dependent behave differently in the flow:

Each flow starts with a registration, which might require eCRFs to be completed or not.
A randomization will allocate a protocol arm by minimization, an eligibility test on the data reported can be part of the design.
An arm can be allocated based on information provided on the eCRFs, either automatically or requiring manual confirmation, by means of a decision node.
A milestone allows manual selection of the next activity, not requiring data completion.
Each flow will end with an end of study flow activity, which is considered as the official stop of the subject in the study flow.

Navigation to Study Flow

The study flow can be accessed by selecting a subject from the subject overview or via the study flow button displayed per subject.

The data section in the Clinical Data module displays both a general navigation button to the study flow as a specific button to the corresponding activity, depending on the event displayed on the screen.

Activity Overview

All reported activities are listed with the corresponding start and end date as well as the user closing the activity, the signature status and the link to the corresponding clinical data (to be completed). The color of the clinical data button reflects the validation status of the corresponding data (red = all missing, yellow = incomplete, blue = outstanding issues, green = no issues).

Selecting an activity in the overview causes the activity details to be expanded. The activity details give access to the activity specific audit trail and displays relevant data linked to that activity. For a randomization or the activity details give access to the allocated arm, and for an eligibility test its shows the results generated by such test activity.

If the activity is still in progress (i.e. not closed) the details can contain messages requesting data to be completed or tests to be executed before the activity can be closed.

If the activity is already closed, a button is displayed which allows you to navigate to the next activity. This option automatically collapses the current activity and expands the next activity in the overview table.

Reset or Restart an Activity

If for some reason an incorrect 'next activity' was chosen at some milestone, you can select that milestone in the study flow and select 'Reset Activity'. This will re-open this milestone and allow you to select the appropriate next activity. With a reset, the activity remains in the version it was initiated in.

For example after the milestone Treatment Arm 1 the user had at first selected Follow-Up as next activity (with surgery also being an option) and so the Treatment milestone closed and Follow-Up was initiated. Later on the user could realize that the subject had gone for surgery prior to follow-up and so needs to reset the Treatment milestone to be able to select the Surgery milestone next.

Please note that downstream milestones or end of study flow activities will be deleted, but any CRFs that were already completed for downstream activities or events will be kept.

Registration, randomization and decision node activities cannot just be restarted or reset. If for some reason the pathway selected does not match the actual situation, then please provide a comment on the subject level, detailing where or what it went wrong and contact the sponsor.

Restart will have the same effect as a reset, with this difference, that the activity will restart in the most recent version of it.

Graphic Study Flow

The graphic study flow indicates the theoretical possible pathways corresponding to the protocol and highlights the subject specific pathway. The difference in colors of the activities indicate the status of the activity.