Release Notes IBM Clinical Development v (formerly eclinicalos) Release Date: 03 February 2017

Transcription

1 Development v Document Version: 10 Release Notes IBM Clinical Development v (formerly eclinicalos) Release Date: 03 February 2017 OVERVIEW Purpose: This document provides an overview of IBM Clinical Development v released by IBM Corporation Background: IBM Clinical Development (formerly 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, and Laboratory Normal collection to help manage different aspects of the trial Documentation: User manuals for all features in the system are available online within IBM Clinical Development by clicking Online Help from the landing page or User Manuals from the help links in the header TRANSITION TO IBM As many of you are aware, Merge Healthcare was purchased by IBM's Watson Health division in October 2015 Over the past year, you have seen small changes as we began to integrate with Watson Health and move from a Merge product to an IBM product As of the release on 03 FEB 2017, we are scheduled for formal integration into the Watson Health offerings System access and functionality will not change with the rebranding We will continue to offer the same support and services as we do now We will attempt to deliver these changes with minimal impact and updates will be posted in release notes with each version This name change should not impact any contractual terms or service We appreciate your support in our transition into Watson Health and look forward to our continued positive impact on the industry Thank you for being a part of our eclinicalos family and we look forward to working with you as IBM Clinical Development Copyright IBM Corp 2017 Page 1 of 7 IBM Corp

2 Development v VERSION DETAILS Document Version: 10 The enhancements and features for IBM Clinical Development v are a direct result of your response to the system 1 GENERAL UPDATES FOR IBM CLINICAL DEVELOPMENT REBRANDING With this release, the new name of eclinicalos is being announced At this time there are only minimal changes to the system, but as IBM Clinical Development, the next milestone has been reached with fresh advantages on the horizon that will directly benefit our customers For now, the updates can be seen on the Login page, the Team Studies screen header, and in system notifications 'eclinicalos' has been updated to 'IBM Clinical Development' in these locations Icons have also been updated in several locations, but the meaning have not changed: Default icon for when no Profile picture is uploaded Icons for Lab Normals statuses Ticker on EDC Home Screen Important Message indicator icon on EDC Home Screen Question Mark icon that links to user manual reference points Action icons within page designer Copyright information in footer on all screens TransPerfect logo updated to their new version 2 COPY REPORTS WITHIN THE SAME STUDY IN DESIGNER In a previous release, the ability to copy reports from one study to another was added This mechanism has been expanded to also allow study reports to be copied within the same study A new 'Copy' button on the Build > Study Reports screen was added When clicked, a pop-up window appears to name the report (30 characters max, must be unique for the study) and to choose the source report that will be copied A search field is also available to quickly locate the report to copy The system will create a new report with the same configuration and display the report screen for the user to perform any updates This feature could be applied in cases where multiple similar but complicated reports exist in the same study, allowing you to easily copy and modify one report to create others 3 STUDY MANAGERS CAN EXPORT DATA FROM EDC Previously, Biostatisticians and other team members that did not have Designer access had to either acquire data exports through a Designer on their team or be given study permissions user by user, not for the role, which was time-consuming With this release, the most popular V2 export formats can now be made accessible from the renamed 'Imports/Exports/API' tab in Study Connect using role permissions Copyright IBM Corp 2017 Page 2 of 7 IBM Corp

3 Development v Document Version: 10 Access is provided only to roles with the permission 'Study Connect Exports?' applied AND 'All Sites' access AND the study must be using V2 data exports The role user can then click on the 'Imports/Exports/API' tab and use the 'Generate' button to define a CSV Data Export, SAS Data Export, CSV Data Audit Trail History, or CSV EAM History (if the study is using EAM) The Queue Monitor available on the screen in Study Connect will track the export's progress Data Exports require the following attributes to generate: SAS Version (for SAS exports) Tables (All, or select one or more) Display Value for Codelists in additional column Include/Exclude Audit Trail Tables Specify Revision (All, one, or more) Display or Hide Deleted Data For EAM History, the following attributes are needed: Adjudication Pages (No, Status Only, Status And Data) All Pages (Besides adjudication pages, No, Status Only, Status And Data) Date Filter (optional) Population Selection NOTES: Users can only access the data exports that they have generated From the Study Connect side, only CSV and SAS exports that were launched from EDC are visible because content differs to restrict unblinding information However, CSV Data Audit Trail History and EAM History can be viewed whether launched from EDC or Designer because their content will be the same regardless of where they were generated from All generated exports will be visible from the Designer side For Page, Field, and Site Attachments only the file names are exported which are visible in the EDC as well 4 DATA EXPORTS V2 MULTIPLE TABLE SELECTION When using Data Exports V2, you were previously able to select 'All' tables to include in the export, or choose one table at a time 'All' could produce a large export out of which a user might have only wanted to obtain a few tables However, generating individual exports table by table could be cumbersome This release replaces the dropdown control on the screen with a multi-select so that a variety of tables can be included in the export This feature is available for V2 exports from the Designer and also from Study Connect (if EDC Exports are being used) Copyright IBM Corp 2017 Page 3 of 7 IBM Corp

4 Development v Document Version: 10 5 V2 DISPENSE BACKGROUND IMPORTS Previously, when more than 1000 packages were included in an import the size of the job could cause system slowness and prevent the job from completing With this release, the V2 Dispense interface was updated to handle large and small jobs more efficiently You can still paste package row information into the import box on the right, but the import results box on the left has been replaced When you begin the import job it will run in the background and send an once it is finished This allows you to continue your work in other areas without disturbing the process At that point, you can review the 'Job Results' table where the import results box used to be and that now displays the Requested By name, Date and Time, Job Type, Status (Complete or Error), and the Log (with link to results document) 6 REVISION IDS NOW ALLOW 3 DIGITS Most studies have not needed more than 2 digits for their Revision Identifiers, but this did not take into account long-running studies that have multiple arms If the revision IDs were skipped to make room for further changes in each arm, the study could exceed 99 revisions With this release, the cap has been raised to 3 digits to increase the available Revision IDs to CHANGE MAX LENGTH OF SITE ADDRESS FIELDS TO 450 CHARACTERS IN DISPENSE V2 Previously the Site's Shipping Address fields within the Dispense V2 module had a maximum character length of 250, though the same fields in the rest of the system had a maximum character length of 450 This allowed more than 250 characters to be entered for an address, but prevented the sites from displaying correctly in V2 Dispense Site Shipment Settings page Shipping Address 1-3 fields have now been updated to have a max character value of 450 to match and prevent the display issues 8 BLOCK ACCESS TO THE BLANK CRF GENERATION FUNCTION ON STUDY CONNECT FOR SPECIFIED STUDY ID In specific study designs, EDC user role permissions were used to mask fields on the page, but this restriction was not captured when a Blank CRF was generated within the subject Impacted Study Teams requested a way to block access to the fields in the Blank CRF reports To accommodate this requirement, an attribute has been added that can be updated by a System Administrator (Merge/IBM) on a study-by-study basis The system will recognize the attribute based on the specific Study ID and show or hide the Blank CRF option in EDC The Blank CRF option in the Designer will remain functional regardless of the setting and will contain the fields in question Copyright IBM Corp 2017 Page 4 of 7 IBM Corp

5 Development v Document Version: 10 What you might see: Users in studies with this attribute set will not see the Blank CRFs (for reference) option on the Subject level PDF screen Users in studies without this attribute set will not see any changes 9 REALIGNMENT OF HELP TEXT ROWS Previously, Help Text controls followed by RowStartEnd controls aligned visually with the left side of the first column of the grid created by the RowStartEnd controls This created a gap on the left side of the Help Text The Help Text line will now align with the second column in the table (the control that comes after the RowStartEnd) 10 PREVENT HTML IN SUBJECT QUERY COMMENTS DURING MOVE Previously, when a subject was moved between revisions and it caused a subject query to be added or updated, it was possible for html tags to be added in the associated subject query comment The html tags shown detailed where the query was re-mapped to, so they did not mean anything to the end user and could cause confusion The system was updated so that it does not add html tags in the subject query comments during the revision move process 11 UPDATES TO PRICE BOOK USER INTERFACE The Price Book user interface has been updated with this release to provide more functionality for the IBM Clinical Development finance team and include changes for the upcoming Subscription based model What you might see: Designers may see new warning messages in the Study Designer, under the Process menu, and in Design Attributes (Optional) These warnings appear if there are optional modules configured that do not yet have agreed pricing If the price book does not have pricing yet for the enabled module, a warning message appears that it is not included and will incur an additional charge The user can click 'okay' to dismiss the warning and proceed with the module enabled 12 STUDY ACCOUNTS INFORMATION ADDED TO ADMINISTRATOR TAB Currently, when a study user calls IBM Clinical Development Technical Support they are required to provide a list of information before troubleshooting can begin (can include: full name, address, study, team, company) While this can feel tedious, the information is needed for Support to identify, escalate, and track issues Therefore, this information has been added to the Administration module's Search/Update Users screen showing a user s study access Support will not be able to modify the study access in any way it is for verification only Copyright IBM Corp 2017 Page 5 of 7 IBM Corp

6 Development v Document Version: 10 What you might see: There will be no visible changes for end users End users will benefit from the faster rate of identification and response when they call in 13 REFACTOR ATTACHMENT TYPES AND LINKS Jump to Top With this release, the attachments and links are being refactored to help the system better identify each type of attachment, improve performance, and help maintain consistent behavior Users will not see any changes with this update, but each refactoring is being thoroughly tested to ensure behavior Copyright IBM Corp 2017 Page 6 of 7 IBM Corp

7 Development v Document Version: 10 REVISION HISTORY FOR CONTENT OF THIS DOCUMENT PRODUCT REVISION # AUTHOR/TITLE CHANGES CREATED DATE IBM Clinical Development v Version 10 Angela Reedy Documentation Specialist Initial Version 19 Jan 2017 REVISION HISTORY FOR THIS TEMPLATE TEMPLATE # REVISION # AUTHOR/TITLE CHANGES CREATED DATE QA-1338 Version 01 Emily Malok Instructional Designer Initial version 09 Jul 2014 QA-1356-T3 Version 02 Emily Malok Instructional Changed Template ID for new format 13 Feb 2015 Designer Updated Template design Adjusted template to better describe ecos examples versus required sections Copyright IBM Corp 2017 Page 7 of 7 IBM Corp