Release Notes IBM Clinical Development Release Date: 25 January 2019 Document Version: 10 OVERVIEW Purpose: This document provides an overview of IBM Clinical Development released by the 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 IMPORTANT ALERTS There are three upcoming changes that users need to be aware of and prepare for 1 REMOVAL OF RC4 ENCRYPTION SUPPORT With this release, the support of RC4 encryption will be removed There should not no direct impact to users, since this requirement was removed from supported browsers in 2016 RC4-free versions of Firefox, Chrome, Internet Explorer v11, and Edge are available and should be used for accessing IBM Clinical Development RC4- free versions are IE 10+, Edge, Firefox 36+, Chrome 40+, Safari 8+, and Opera 962 This is the first step towards implementing the Internet Explorer and SSL/TLS changes POTENTIAL IMPACT: Users of Internet Explorer v9 in coordination with Windows XP environments likely have RC4 encryption When used with Later Windows versions, the RC4 was removed Page 1 of 7
Document Version: 10 2 REMOVAL OF SUPPORT FOR INTERNET EXPLORER (IE) V9 AND V10 Microsoft has stopped supporting versions of Internet Explorer (IE) prior to v11 and no longer provides security patches or fixes for these versions IBM has maintained support for these versions to give customers the opportunity to upgrade their browsers Support will be removed early in 2019, with the release of 2019200, which is currently estimated for early March A specific date has not been determined yet, but IE v9 and v10 users will be unable to access IBM Clinical Development once support is removed Users should update their IE version or switch to an alternate browser More details will be provided as they become available 3 REMOVAL OF SUPPORT FOR SSL V3, TLS V10, AND TLS V11 The use of old transport protocols introduces a security risk to IBM Clinical Development Support for these encryption methods has been removed from many common software tools and others have scheduled an end date IBM has maintained older protocols to give customers the opportunity to upgrade their own systems The support will be removed early in 2019 A specific date has not been determined yet, but users should review their internal processes to determine any impact More details will be provided as they become available VERSION DETAILS The enhancements and features for IBM Clinical Development are a direct result of your response to the system 1 STUDY DOCUMENTS: ADD STUDY DETAILS TO DOCUMENTS GENERATED IN THE SYSTEM With the release of, designers are able to include study description details in several of the study documents generated in IBM Clinical Development A new Design Attribute is available to enable the Study Name, Description, Protocol, and Alias to the following documents: Subject PDF cover page Blank CRF cover Page Data Dictionary for v2 Data Exports PDF attached to Add Subject Email PDF attached to Update Subject Email (Includes Randomization action) Page 2 of 7
Document Version: 10 1 STUDY DOCUMENTS: ADD STUDY DETAILS TO DOCUMENTS GENERATED IN THE SYSTEM Study Names that are longer than 180 characters in UTF-8 format will need to adjust their study name before using the new attribute A warning is being added to the Error Widget and it will specify the current number of characters The Study Name field can be updated at any time and a study name longer than 180 characters will not block study document generation without the added details 2 epro: IMPROVE MANAGEMENT OF TIME WINDOWS The epro module captures information about two types of records -- completed and those incomplete where the subject started but did not submit their diary Study Teams have asked for a method to track the diaries that are pending or that were not completed at all (missed) To help meet this need, a new table is being created (EDC_EPRO_WINDOW) to capture time window records This will enable new 'missed' and 'pending' statuses The system will determine the window for each subject diary based on the associated rules Previously, windows were calculated when the subject accessed their diary With this release, a repeating check has been added to update the window table to account for subject actions, new subjects activated, and any data updates on schedule This will enable the identification of what is missed as well as what is available The window and diary availability will be updated for any combination of Begin/Expire rules (Begin, Expire, or both) if the reference date is changed If a Daily or Daily with Time Window rule is associated with the diary, the window cannot be updated if the reference changes since it could invalidate existing records The epro section of the Subject View (grey bar link) will now include Complete, Available, Incomplete, and Missed tables to display records for the subject Subject users will be able to see Missed records on their landing page The subject PDF will also include the Missed Diary table It will include Visit, Page, Status, Window Start (GMT) and Window End (GMT) IMPORTANT: Missed windows will only be captured after the IBM Clinical Development release Diaries missed prior to the release will not be included in any tables Page 3 of 7
Document Version: 10 3 epro: EXPANDED EMAIL SUBJECT LINE AND BODY FOR epro NOTIFICATIONS Study teams requested that the email notifications set up on the epro Visit Schedule rules be expanded At this time, these notifications cannot be set up for different languages, so the teams wanted to provide all translations in the same email subject/body fields To assist with this, the following changes are included in v: the limit of Email Subject Line is moved from 100 char to 250 char the limit of Email Body is moved from 1000 char to 3500 char 4 NEW MODULE: OPTUM QUESTIONNAIRE INTEGRATION Optum is an organization that licenses the SF-36 and other health surveys to measure a patient's well-being These surveys can be provided in multiple ways but need to be scored through Optum With the release of, IBM Clinical Development will be integrating with Optum to enable SF-36 collection and the return of Optum assessments to our system This is a new optional module, which includes Optional Design Attributes and Visit Schedule Rules to set up Based on a trigger, the information collected in IBM Clinical Development will be transferred to Optum When they complete the evaluation, their information will be transferred back to IBM Clinical Development and populate specific CRF fields NOTE: Use of Optum surveys requires a contract/license provided by Optum IBM does not negotiate or manage customer licenses 5 ENDPOINT ADJUDICATION: ADDITION OF BATCH ASSIGNNMENT OF MEDICAL REVIEWER Previously, a batch assignment option was added for Adjudicators on studies where the Adjudicator is not automatically assigned by the system In 20181000, the ability to assign a Medical Reviewer was also included With the release of, a batch assignment of Medical Reviewer is being added This functionality is on the main Endpoint Adjudication tab in EDC and allows the user to review the events, select those to be assigned to a specific user and provide any comment or explanation needed NOTE: The availability of Medical Reviewers to assign to will depend on the site permissions associated with the role user and the current unassigned events Page 4 of 7
Document Version: 10 6 COGNOS: ENABLE USER DEFINED AUDIT TABLES The integration with Cognos will pull data and design tables from core IBM Clinical Development User defined tables are those that are created by the design of the study This is in comparison to standard tables created by the system for all studies The User Defined Tables are related to the data collected and therefore have an audit trail associated with them This information is also needed in the Cognos datasets for reporting With the release of, the audit tables will be included in the study data transferred to Cognos 7 COGNOS: REPORT FOLDER PERMISSION CHANGES Due to the way that Cognos manages user permissions, updates were required to provide access to run or edit reports for non-owners If a user is part of the Study Users role group, they will be able to read the report in EDC/Study Connect If a user is part of the Study s role group or both the Study user/study s groups, they will now be able to run or edit a report The role group permissions are assigned by the owner of the report 8 DATA EXPORTS: ADD ADMIN PERMISSIONS TO MANAGE NUMBER OF EXPORTS ON A TEAM LEVEL Currently, study teams are able to schedule up to 4 recurring exports per type per 24 hour period The meets the needs for most studies, but some designs require additional recurring exports This is defined in their contract, so a method was needed to meet this requirement IBM Clinical Development Admin users can now create a team-specific property that will override the current limit NOTE: This permission is not available to general Study s and may be associated with additional costs Please contact your IBM Seller or Solution Manager if you would like more details about expanding your recurring data exports 9 PERFORMANCE: UPDATE METHOD OF CROSS-PAGE QUERY LOOKUP The current method for managing cross-page queries uses a higher number of resources than it should This is due to legacy queries and the lack of caching With the release of v, the queries have been updated to improve efficiency and therefore performance Page 5 of 7
Document Version: 10 10 EPRO: ENABLE CHECK FOR EPRO MOBILE APP USE BEFORE SENDING PUSH NOTIFICATION IBM Clinical Development can provide email notifications via email address or push notifications via mobile app to epro subjects While emails can be received on a mobile device, a push notification will appear on screen whether the app is active or not and without needing the user to open any browser, email app, or the My Clinical Diary app Push notifications, though, require the My Clinical Diary app to be used When the system is checking for notifications for a study using epro, it traditionally would attempt to send using both email and push However, if the study is not using the My Clinical Diary apps, the push would not work To prevent this, the system will now verify whether the mobile apps are available for the study/subject (Design Attributes (Optional) > epro > "Enable the epro mobile app?" = "Yes" or "No") If the attribute is YES, the push notification will go out Page 6 of 7
Document Version: 10 REVISION HISTORY FOR CONTENT OF THIS DOCUMENT PRODUCT REVISION # AUTHOR/TITLE CHANGES CREATED DATE IBM Clinical Development Version 10 Emily Malok Initial Version 11 Jan 2019 REVISION HISTORY FOR THIS TEMPLATE TEMPLATE # REVISION # AUTHOR/TITLE CHANGES CREATED DATE QA-1338 Version 01 Emily Malok Initial version 09 Jul 2014 QA-1356-T3 Version 02 Emily Malok QA-1356-T3 Version 03 Emily Malok QA-1356-T3 Version 04 Emily Malok QA-1356-T3 Version 05 Emily Malok QA-1356-T3 Version 06 Emily Malok Updated: Changed Template ID for new format Updated Template design Adjusted template to better describe ecos examples versus required sections Not Used Iterated to bring template up to the same version as the SOP (changed guidelines) Updated the company name and branding for the product Updated revision due to update of associated SOP Updated revision due to update of associated SOP 13 Feb 2015 19 May 2017 19 May 2017 22 Dec 2017 30 May 2018 Page 7 of 7