Document Title: External Release Notes Document Version: 1.0
Transcription
Document Title: External Release Notes Document Version: 1.0
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 . Page 1 of 4 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. Template Name: External Release Notes Template Doc. ID: QA-1338 . Page 2 of 4 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 Template Name: External Release Notes Template Doc. ID: QA-1338 . Page 3 of 4 Confidential and Proprietary 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. Template Name: External Release Notes Template Doc. ID: QA-1338 . Page 4 of 4 Confidential and Proprietary