Document Title: External Release Notes
Document Version: 1.0
Document Type: Template
Area: Core Product Release Rollout
Release Notes
Merge eClinicalOS v5.8.0.0
Release Date: 07 November 2014
OVERVIEW
Purpose:
This document provides an overview of Merge eClinicalOS v5.8.0.0 released by Merge Healthcare’s
eClinical division.
Background:
Merge eClinicalOS is a Software as a Service (SaaS) application available for clients to design, deploy, and
manage their clinical trials. It provides design tools for each aspect of the design and management
process and provides an EDC interface for end-user data collection. It also provides additional tools such
as ePRO access, Randomization, Dispense/Shipping Management, Endpoint Adjudication, Medical
Coding, Laboratory Normal collection, and now featuring a new Cohort module to help manage different
aspects of the trial.
Documentation:
User manuals for all features in the system are available online at the eClinicalOS site as appropriate for
user accounts. For additional information, please contact the Merge eClinicalOS Tech Support team at
[email protected].
VERSION DETAILS
The enhancements and features for eClinicalOS v5.8.0.0 are a direct result of your response to the
system.
1.
NEW MODULE: COHORTS
With this release, eClinicalOS introduces a new optional module. The Cohorts Module allows
Client Administrators to better monitor drug dosage and effects based off of subject groups.
Subject groups can be created by classifying participants with similar demographics or medical
history data. The use of Cohorts will minimize the incidence of impact these factors may have
when analyzing trial procedure outcomes.
In addition to this, Cohorts help to determine the ideal dose of a drug. With the Cohorts
module, control is given to the clinical study team, empowering them to closely manage the
study. This eliminates the need for a study designer to administer cohorts each time a change is
required.
Template Name: External Release Notes
Template Doc. ID: QA-1338
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Confidential and Proprietary
Document Title: External Release Notes
Document Version: 1.0
Document Type: Template
Area: Core Product Release Rollout
Cohorts involves set up in both the Designer and in EDC. Within the “Designer” it involves
design attributes, roles, and Cohort definitions. Within the “EDC” management includes options
for updates during conduct if required.
IMPORTANT: Cohort Module tools require the use of the Advanced Expression Editor and is only
available in V2 exports.
2.
Planned Studies: Go Live Dates
In the past Go Live dates within eClinicalOS did not always match up with the information
entered into Planned Studies. Often times, this was a result of shifting dates.
To better capture billing information, and ensure a correlation between what is entered in the
Studies Attributes and what is presented within Planned Studies a prompt will appear every 30
days. This pop up dialog will display a list of planned studies that may requiring updating. The
start and stop date of a study can be edited directly within the pop up or click on the provided
link to access the actual planned study record. The ‘Planned Study’ status can be updated from
the dialog box as well.
An alert will also appear if there is study that is not yet live but has a start date that is either
overdue or approaching within 90 days. This new feature makes it easy for account admins to
keep accurate records for financial planning and budget purposes.
3.
Medical Coding Report
There were 2 changes associated with the Medical Coding Module.
3.1
Medical Coding Report
A new report template has been created for the Medical Coding module. These advanced
features will empower the user to create a listing reports with select CRF data and
verbatim/dictionary. Designers can now create exportable reports which list BOTH the Medical
Coding Items and a desired subset of the CRF data which can be access via a link in the Medical
Coding module.
3.2
Medical Coding Tab
This release also features multiple filtering functionality for coders to visualize items based off of
certain parameters. The filter options are available in both the new Medical Coding Report as
well as the “View Items” screen within the Medical Coding tab of the EDC. The filters allow for
more specific data visualization. Multiple parameters can be applied by using the AND operator.
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Confidential and Proprietary
Document Title: External Release Notes
Document Version: 1.0
Document Type: Template
Area: Core Product Release Rollout
4.
Endpoint Adjudication Updates
There were 3 changes associated with the EAM Module.
4.1
Role Permissions
Within the EAM Module it is sometimes required to delete or remove a dossier or an event
attachment that was originated by another user. In the past it was required to have the EAM
Admin permission to perform these tasks. With this new update however, only one role
permission is required. If a role needs the ability to delete a dossier created by another user,
the permission ‘Create Dossier’ is sufficient. For those who need to delete an event attachment
added by another user, the permission ‘Edit EAM’ can be used. This new change safeguards the
EAM Admin permission for those roles who require administrative capabilities over the EAM
Module.
4.2
Deletion of EAM Records
When using the Endpoint Adjudication module, there may arise a situation where the deletion
of an EAM record is required. Prior to this release, when an EAM event was “Mark as deleted”
the correlating CRF’s would remain unless manually and separately marked as deleted. Now
however, when an EAM record is expunged all associated event pages will also be deleted. This
feature, which will be set as the default behavior when creating a new rule, will decreases the
risk of redundant work and provides continuity of the EAM module. Study designers have the
ability to toggle this feature on and off within the EAM rule.
4.3
EAM View Events Screen
Events within the Endpoint Adjudication module are captured in the View Events Screen. This
table provides details for user to review and access individual EAM occurrences. The new layout
correlating with this release, will obtain the previous versions column data with some additions.
The View Events screen will now contain columns that capture the phase the event is currently
in, along with the quality control status and results.
In addition to the new table design, this release will feature an advanced filter option. It is now
possible to combine several filter parameters with an AND operator refining the results. These
enhancements enable result page browsing, real-time search, and advanced filtering.
5.
Advanced Expression Editor: Site Information Operators
The Advanced Expression Editor will be gaining additional functionality with the introduction of
this release. A new operator labeled “SiteProperty” has been added that can capture valuable
site information like Site Name, Site ID, and Country/Region. The ability to add site level
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Document Title: External Release Notes
Document Version: 1.0
Document Type: Template
Area: Core Product Release Rollout
information to expression within the Advanced Editor is an integral piece in correlation to the
new Cohorts module.
6.
Study Manager: Site Packet
With this release a new role permission “Manage Site Packets” has been added to allow a user
the ability to create and manage Site Packets within the Study Manager module.
7.
Add Visit/Change Request Button
Previous versions of eClinicalOS featured the “Add Visit” and “Add Change Request” button with
the wording “Add” + “Visit”/”Change Request”. The word “Add” will now be replaced with a
plus icon (+). This change contributes the continuity of action buttons through eClinicalOS and
helps reduce user confusion.
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Template Doc. ID: QA-1338
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