Summary

The 23.3 release contains improvements covering data review workflows and API capabilities. There are also minor changes that improve user experience across several features. This article summarizes several key changes, based on the Release Notes content in the Technical File.

A related blog post on the release contents can be found here: ClinSpark Version 23.3 is now available

Updates to Build Formatting

23.3 slightly changes the display of build details in order to alleviate some confusion in formatting. 

In prior releases, the format excluded ISO standard references to characters of hyphens, colons, and use of “T” (time) separator.  Additionally, prior releases used “+0000” for timezone offset instead of “Z” for UTC. 

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Example of prior release build detail and formatting

Going forward, full datetime format is YYYYMMDDTHHMMSSZ, comprised of these parts:

• Build Date as YYYYMMDD

• "T" as time separator

• Build Time as HHMMSS

• "Z" representing UTC timezone 

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The new presentation of build details

While these changes may seem rather minor, they’re made in efforts to harmonize the display of version & build details for ClinSpark, Agent, and other platform releases where appropriate.

The ClinSpark Version and Build details are visible to users on the login screen, and, the ‘About’ menu item.

Controls Showing Item Data Value Changes

A primary focus of the release was to implement stronger controls in support of data review workflows requiring audit trail reviews. The intention is to bring information about Item data changes into clearer view to support risk-based audit reviews and help sites determine if changes against Item data are intentional.

User interface icons and Status filers in the Study > Data component have been added to allow users to locate instances where original data entry on study data Item values have been changed. Users will now see a specific ‘strike-through’ (S) icon listed next to any Item values that have been changed from their original collected value. The strike-through icon was selected as the visual because it illustrates how a value is changed, in adherence with GCP.

Additionally, a Status filter called ‘Data Value Changed' can be used to focus on timepoints where Items meet this criteria.

Audit trail reviews may not be against data itself, but on retrospective changes made to data. Regardless of the use case, changes may need to be reviewed by a qualified user to ensure the change was expected.

This functional change aims to provide more controls capable of showing users where original item data values may have been changed over time.  These changes further extend on existing Item audit trail views and certain reports as well, such as Data Audits and Annotations.

Data Audits and Annotations (Report)

More information about Data Review workflows can be reviewed here:

Reviewing Data

API Feature Enhancements

Several changes were made that impact the use of API features.

Report API

The endpoint ‘invokeReport’ now prevents a given study report from generating if the user account does not have access to the study. Details about this change and other Report API functions can be reviewed in this documentation: https://foundryhealth.atlassian.net/wiki/x/pAAd3Q

Token Based Authentication

Changes in 23.3 bring API authentication mechanisms up to a more modern standard, in addition to being a ‘stepping stone’ towards a more robust authentication strategy we intend to explore at a later time. This release implements bearer auth tokens, which are more secure than basic authentication.

New role actions support these features. API tokens can be created and managed on a per user account. Additionally, user provisioning workflows now allow customers to determine if basic or token based auth methods are acceptable for each user account. Token attributes are displayed to users when managing user accounts, and also provide details on when tokens were issued and used.

A full writeup on these new features can be reviewed in the API documentation here: ClinSpark APIs | Supported Authentication Schemes

MD5 Checksum Calculation

ClinSpark generates an MD5 checksum for configurations supporting reports, dashboards, and various system settings. 23.3 supports an improved method of calculating the checksum values. The checksum calculation now ignores whitespaces contained in script/setting values and presents to users in the original MD5 format instead of Base64 encoding.

More details about MD5 checksums and their use can be found on this article:

Report and Dashboard Versioning in ClinSpark | MD5 checksums as component versions

Improving File Size Limits for Items

23.3 expands upon an existing feature allowing PDF files to be attached to Form Items, now increasing the acceptable Item Data file size to 100MB. The previous limit was 10MB.

This is of practical benefit to study teams that may need to add large PDF files to study forms. More information about file uploads and size limitations are noted on our documentation site.

File Upload Limitations

Performance Improvements for Medical Coding

Studies may require coding workflows to take place across hundreds of terms and several item groups. Prior to this release, all records requiring attention would render into view and would sometimes cause the page to load for a long period of time. This was a non-ideal user experience. Going forward, pagination and additional controls over records brought into view will make medical coding workflows more efficient for users.

Removing Volunteer Profile Image from Cohort Managment Area

Cohort assignments are rarely managed ‘in front of’ a participant and the need to verify a volunteer's identity with their profile photo for a cohort assignment is often not needed. Additionally, there may be a privacy concern with a volunteer’s photo being present to users this area of the application without proper context.

With current role action coverage users who have access to the Study > Configure module, and by extension this area of the application, may not always be permitted to see volunteer details such as their photo.

23.3 now limits the amount of volunteer information necessary to complete cohort management workflows and ensure that volunteers photos are appropriately presented in areas outside of the Volunteer component.

Qualified users in the cohort management areas, with role action coverage allowing access to the Volunteer module, can still access a direct link to a given volunteer’s profile and access their photo if necessary.

Expanding on Existing Form ‘Move’ Workflows

A study form ‘move’ feature was introduced in prior releases but made exclusive to superadmins. This was because the feature set was conceived mainly as a support function focused on late-phase study workflows, however, we’ve learned that having this capability in the hands of study teams directly can help address a variety of challenges across all types of studies.

Now in 23.3, non-superadmin users can now utilize study form ‘Move’ functionality. Quite simply, this feature allows a user to modify the site, subject, and study event attributes with a given Form. This feature is supported by a specific role action called ‘Study Data Move Form Data’.

Details about the new role action and feature are noted here: Role Actions | Study Data Move Form Data

Showing Lab Specimen Comments in Lab Data Results

A minor UI improvement was added into the Study > Lab Data component. We now surface specimen comments within the resulted data views, if the comments are present in the data set for a given panel.

In previous releases, these comments were only visible to authorized users who were also given role action permission to see the full panel details, which includes more than just the resulted data set. This information is present in the Lab > Orders component.

Under certain scenarios, its not always desirable to allow certain users the ability to see all specimen details (including certain results, study ranges, alerts, and review comments) and be granted access to the Lab > Orders component. By bringing these comments forward into existing Lab Data review component customers can ensure that proper roles are configured for users to view these comments, and, prevent the number of areas of ClinSpark a user needs to be granted access (and navigate to) in order to view the lab comments.