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Release Notes Product: IBM Clinical Development Document Version: 0.1 2020.4.0.0 Area: Development Document Type: Record Document Title: Technical Release Notes Product: IBM Clinical Development Document Version: 0.1 2020.4.0.0 Area: Development Document Type: Record Technical Notes IBM Clinical Development 2020.4.0.0 Release Date: 28 June 2020 OVERVIEW Purpose: This document provides an overview of IBM Clinical Development 2020.4.0.0 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. IMPORTANT ALERTS There are two upcoming changes that users need to be aware of and prepare for. 1. CHANGES TO THE IBM CLINICAL DEVELOPMENT WEB ADDRESS Traditionally, users have accessed IBM Clinical Development (ICD) through the secure.eclinicalos.com web address (URL). However, the eClinicalOS name was changed when we transitioned to IBM in 2017. During Q3 2020, we will be updating the web addressDRAFT to secure.clinicaldevelopment.com. More details about the schedule for the transition, redirects, and updating bookmarks will be provided before the change-over. Template #: QA-1356-T6 Licensed Materials – Property of IBM Page 1 of 11 Revision #: Version 06 © Copyright IBM Corp. 2020. US Government Users Restricted Rights – Use, duplication or disclosure restricted by GSA ADP Schedule Contract with IBM Corp. Document Title: Technical Release Notes Product: IBM Clinical Development Document Version: 0.1 2020.4.0.0 Area: Development Document Type: Record 2. UPDATES TO IBM CLINICAL DEVELOPMENT APIS Over the past few years, the use of the APIs has increased and the technology and processing around them has also advanced. As with most things, older APIs may no longer meet security or functional needs. In addition, some older code to access the APIs may need to be updated. With a scheduled release in Q3 2020, IBM Clinical Development (ICD) will start blocking some old code that does not meet security requirements. This will occur after the transition to the Raleigh Data Center, but a final date is not yet set. We are currently working to assess the impact, but since this is related to customer- side coding, we may not identify all cases and are alerting you early so you can review. 1. XML WEB API AUTHENTICATION Previously, ICD allowed customers to pass requests using a URL query string or Form Data. The URL Query String will be blocked. Authentication information for the URL Query String may be captured in internal/system logs and IBM will not assume responsibility for these details. The new standard for authentication will be: - must use POST method - must use a Content-Type header equal to "application/x-www-form-urlencoded" - must encode credentials in the request body using standard Form encoding - must not pass credentials in URL (query string) Customers using a URL Query String should update their API requests to meet these criteria before the implementation in Q3 2020. Customers currently using the Form Data with these standards are not impacted. 2. WEB API REQUEST TYPES The ICD securityDRAFT will block requests where the mime type does not match the content, even if the content is valid. The following are acceptable requests: - JSON request are sent with Content-Type equal to "application/json" - XML request are sent with Content-Type equal to "application/xml" Template #: QA-1356-T6 Licensed Materials – Property of IBM Page 2 of 11 Revision #: Version 06 © Copyright IBM Corp. 2020. US Government Users Restricted Rights – Use, duplication or disclosure restricted by GSA ADP Schedule Contract with IBM Corp. Document Title: Technical Release Notes Product: IBM Clinical Development Document Version: 0.1 2020.4.0.0 Area: Development Document Type: Record 2. UPDATES TO IBM CLINICAL DEVELOPMENT APIS Customers using a mismatch of type-to-content should update their API requests to meet this criteria before the implementation in Q3 2020. Customers currently using correct mime type to content will not be impacted. NEW FEATURES INCLUDED IN THIS VERSION A new feature is defined as functionality that is not related to other tools in that segment and was not present in the system before this release. There were no new features included in the IBM Clinical Development 2020.4.0.0 release. UPDATED FEATURES IN THIS VERSION Jump To: Top New Features Defect Fixes Additional Notes An updated feature is defined as functionality that adds to or expands upon already existing tools. This may be additional behavior or options for use as well as interface or user experience changes. The following enhancements and updates to existing features were included in the IBM Clinical Development 2020.4.0.0 release. 1. IBM CLINICAL DEVELOPMENT IS MOVING TO THE NEW IBM RALEIGH DATA CENTER A Data Center is a designated space to house the physical computer system and components. It also includes redundancies or back-up components to ensure continuity of service. Traditionally, IBM Clinical Development has used Flexential/Peak10 Data Centers to house our infrastructure. To take advantage of additional resources and security through IBM, IBM Clinical Development will now be housed in the IBM Raleigh Data Center. This also includes a move from Linux Virtual Machines to the IBM Private Cloud. DRAFT These changes include all components of IBM Clinical Development, including the core database, optional modules, APIs, storage, batch processing, and finance support systems. The features and functions in the system are not changing with this move. This is limited to the architecture and supporting platforms. Template #: QA-1356-T6 Licensed Materials – Property of IBM Page 3 of 11 Revision #: Version 06 © Copyright IBM Corp. 2020. US Government Users Restricted Rights – Use, duplication or disclosure restricted by GSA ADP Schedule Contract with IBM Corp. Document Title: Technical Release Notes Product: IBM Clinical Development Document Version: 0.1 2020.4.0.0 Area: Development Document Type: Record 2. ARCHITECTURE: SUPPORT FOR SAS SERVER In order to generate data exports in SAS or MS Access format, IBM Clinical Development requires a separate server with SAS software. With the move to the IBM Raleigh Data Center, the communication between servers is changing, so the process to access the SAS server must also be adjusted. The request process, recurring/scheduled process, optional attributes, and content for SAS or MS Access data exports will not change. Users will not see any change and do not need to update any exports/transfers. 3. ARCHITECTURE: SHIFT TO KUBERNETES Kubernetes (or k8s) is a tool used to help manage deployments, scaling, and cloud services. This change will help IBM manage the IBM Clinical Development system, architecture, and releases better in the cloud environment. This does not change any IBM Clinical Development functionality. 4. ARCHITECTURE: UPDATES TO CrushFTP SERVICE CrushFTP is a multi-protocol, multi-platform file transfer server. IBM Clinical Development has traditionally used a stand-alone version for transferring data out of (i.e. data export transfers, shipper integrations) and into (i.e. data migrator jobs) the system. With the move to the Raleigh Data Center, the system will move to a Kubernetes-based CrushFTP server. This does not change any IBM Clinical Development functionality, just the methods used on the back-end to perform system actions. 5. ARCHITECTURE: ENABLE ADDITIONAL LOGS FOR RUBY MODULES Ruby is used for several optional modules, including the Data Migrator, Monitoring Management, Study Manager, and v2 Inventory/Dispense. Logs are used to monitor and researchDRAFT behavior in the system. With the move to the Raleigh Data Center, the logs are being expanded to better cover the Ruby applications. This includes new logs as well as expanded content for existing logs. Template #: QA-1356-T6 Licensed Materials – Property of IBM Page 4 of 11 Revision #: Version 06 © Copyright IBM Corp. 2020. US Government Users Restricted Rights – Use, duplication or disclosure restricted by GSA ADP Schedule Contract with IBM Corp. Document Title: Technical Release Notes Product: IBM Clinical Development Document Version: 0.1 2020.4.0.0 Area: Development Document Type: Record 5. ARCHITECTURE: ENABLE ADDITIONAL LOGS FOR RUBY MODULES The change in the logging does not impact the functionality of any of the modules or any specific study design or user access. It is limited to administration. 6. ARCHITECTURE: UPDATE SUPPORTING SOFTWARE - APACHE TOMCAT IBM Clinical Development uses Apache Tomcat to support the user interface with dynamically generated web pages. During the migration to the Raleigh Data Center, this software will be updated to a new version to provide increased security. There are no functional changes in IBM Clinical Development releated to this change. 7. ARCHITECTURE: PROXY HANDLING FOR FILE TRANSFERS TO CUSTOMER SERVERS FTPS and SFTP are file transfer protocols used to transfer data files between systems. With the move to the Raleigh Data Center, the system will require customer servers to be white-listed before an outbound transfer can take place (IBM requirement). All uses of SFTP or FTPS file transfer protocols throughout the system must be whitelisted, including imports, exports, safety reporting along with any custom implementation of the same. This architecture change enables settings already created for the SFTP protocols to be used for the FTPS ones for consistent handling. Customers using FTPS or SFTP transfers for V1 or V2 Data Exports, Data Migrator jobs, Safety Reporting, Imports, or custom work will need to be white-listed.
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