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.

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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"

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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.

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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.

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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. Please review the conditions and actions needed: 1. Current jobs will not be affected – these have been pro-actively white-listed during our setup of the data center. 2. Future jobs using the same server and port as current jobs will not be affected. Some customers use the same server/port and just change the credentials for each study and this will be supported without any further actions. 3. Customers using IBM’s FTP server are not impacted. The IBM Servers are alreadyDRAFT set up to handle the transfers. 4. Use of a NEW server (unknown to IBM at this time) will need to be white- listed.

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7. ARCHITECTURE: PROXY HANDLING FOR FILE TRANSFERS TO CUSTOMER SERVERS

To white-list a server, please contact Support with the following details: • For SFTP – Provide (a) the Server Domain and (b) the Port. IBM strongly recommends using a DNS name, but will accept an IP Address. For example, mysftpserver.example.com, port 2222.

• For FTPS – Provide (a) the Server Domain, (b) the Connection Port, and (c) the Data Connection Port Range. FTPS connections use two or more ports, one as a control connection and then dynamically assigned ports for data. IBM needs to know about all the ports involved in order to setup our white- list. For example, myftpsserver.example,com, connection port 21, data ports 61000-61100.

IBM strongly recommends that customers pro-actively white-list their servers in advance, to prevent delays with use in a study. White-listing an SFTP will typically take 2 business days to complete, but white-listing an FTSP will take up to a week.

8. ARCHITECTURE: UPDATE SUPPORTING SOFTWARE - JDK

IBM Clinical Development uses the Java Development Kit (JDK) for a variety of programming tools that support the system.

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 related to this change.

DEFECT FIXES INCLUDED IN THIS VERSION Jump To: Top New Features Updated Features Additional Notes

A defect fix is defined as an DRAFTupdate to the existing behavior or interface to correct a problem. This problem may include unexpected errors, incorrect behavior by the system, or updates based on user concerns or feedback for designed behavior. The following defects and fixes were included in the IBM Clinical Development 2020.4.0.0 release.

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1. ARCHITECTURE: UPDATED ERROR MESSAGE

Jersey is a framework for API web services for platforms using JAVA and is part of the architecture supporting IBM Clinical Development. During testing for the move to the Raleigh Data Center, it was found that certain messages included with Jersey contained information that should not be public.

Based on this finding, these messages have been modified and contain only limited detail in the IBM Clinical Development environment.

ADDITIONAL NOTES FOR THIS VERSION Jump To: Top New Features Updated Features Defect Fixes

The following additional information is included in release documentation. These notes do not reflect changes made to IBM Clinical Development for the 2020.4.0.0 release.

1. Regression Testing

There were no unscheduled patches since the release of IBM Clinical Development 2020.4.0.0 and therefore no tickets were identified for additional testing and support.

2. Deferred Defects

IMPORTANT: NO DEFERRED DEFECTS ARE EXPECTED. THIS IS FOR FORMAL PROCESS TRACKING ONLY.

Use one of the following: • There were no deferred defects for IBM Clinical Development 2020.4.0.0. • XX minor defects were discovered during testing and they were determined not significant enough to delay the release of IBM Clinical Development 2020.4.0.0. Details are outlined below.

YOU WILL NEED TO DRAFTLOOK FOR AFFECTS VERSION (YOUR RELEASE) OR CHECK THE PQA TEST REPORT

Manually add them here…

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2.#. Summary

Explanation

Status: Deferred

[ Repeat table as needed ]

3. Additional Support Updates

Additional areas of the user manuals were updated with this release, not due to changes with IBM Clinical Development 2020.4.0.0 but to clarify existing features, restrictions or limitations. These are:

3.1. ADDITIONAL RESOURCES FOR MID-STUDY UPDATES

After a recent User Forum on the Mid-Study Update (MSU) process, customer tips and sample forms have been added to the MSU section of the manual. The former Checklist page has been updated to Mid-Study Update Resources. Additional resources have also been added to the Study Team Resources page on the team landing page.

Noted In: • Mid-Study Updates > Mid-Study Updates > Cheat Sheet: Mid-Study Update (Renamed)

4. System Details

IMPORTANT: The following information is provided as a courtesy for study supporting documentation. This does not impact your study design or use of EDC.

ALERT: With the transition to the IBM Raleigh Data Center, the information provided will be changing. For this release, both the traditional identifiers for the Flexential/Peak 10 architecture as well as the identifiers for the Raleigh Data Center architecture are being provided. After the move, only the Raleigh Data Center identifiers will be provided. DRAFT 5.1. CURRENT PRODUCT VERSIONS – FLEXENTIAL/PEAK 10

The release on 28 June 2020 contains:

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Document Title: Technical Release Notes Product: IBM Clinical Development Document Version: 0.1 2020.4.0.0

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IBM Clinical Development 2020.4.0.0 Core Build #1593 7c77710

APPLICATIONS Data Migrator 658359d ecosapi e76d9d3 ctmsi 3713924 dispense ea673bf Monitor Management 33f5df0 ePRO PWA ac32b50

SERVICES Storage Services dc85243 Smart Reports Topology Build #162 a7ed862 Smart Reports SSO e658d96 Cognitive Medical Coding - Server Build #7 9d533a6 Cognitive Medical Coding - Model 9d533a6

ARCHITECTURAL SUPPORT Study Manager

DICOM/Imaging (Legacy) Uploader 2.0.0 iConnect Access viewer 7.1.0

5.2. CURRENT PRODUCT VERSIONS – RALEIGH DATA CENTER

The release on 28 June 2020 contains:

IBM Clinical Development 2020.4.0.0 ICD Umbrella 6f7ffc0 Postfix Umbrella e4aaba1 SmartDRAFT Reports Topology Build #162 a7ed862 Smart Reports SSO e658d96

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Document Title: Technical Release Notes Product: IBM Clinical Development Document Version: 0.1 2020.4.0.0

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REVISION HISTORY FOR CONTENT OF THIS DOCUMENT

DOC # REVISION # AUTHOR/TITLE CHANGES CREATED DATE

IBM Clinical Version 0.1 Emily Malok Initial Version/Draft. 28 May 2020 Development Instructional 2020.4.0.0 Designer

IBM Clinical Version 1.0 Name Final: Summarize Changes TBD Development Title 2020.4.0.0

REVISION HISTORY FOR THIS TEMPLATE

TEMPLATE # REVISION # AUTHOR/TITLE CHANGES CREATED DATE QA-1345 Version 01 Emily Malok Initial version. 09 Jul 2014 Instructional Designer QA-1356-T6 Version 02 Emily Malok • Changed Template ID for 13 Feb 2015 Instructional new format Designer • Updated Template design • Adjusted template to better describe eCOS examples versus required sections • Split template for unscheduled and scheduled for clarity QA-1356-T6 Version 03 Emily Malok Not Used. Iterated to bring 19 May 2017 Instructional template up to the same version Designer as the SOP (changed guidelines) QA-1356-T6 Version 04 Emily Malok Updated the company name and 19 May 2017 Instructional branding for the product Designer QA-1356-T6 Version 05DRAFT Emily Malok Updated revision due to update 22 Dec 2017 Instructional of associated SOP Designer QA-1356-T6 Version 06 Emily Malok Updated revision due to update 30 May 2018 of associated SOP

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TEMPLATE # REVISION # AUTHOR/TITLE CHANGES CREATED DATE Instructional Designer

DRAFT

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