OpenClinica 4 – Release Notes 2023

Modified on Wed, 2 Jul at 1:25 PM

OpenClinica 4 Stack 18.1.2 (Release Date - 02 August 2023) OpenClinica 4 Stack 18.1.2 contains targeted updates to Insight. View the entire Stack 18.1.2 changelog here (login required). For an overview of this update, view the Stack 18.1.2 Release Announcement here. Overview information and detail breakdowns can be found in 18.1.2 Detailed Log here.

Changes and Fixes:

Insight

Security enhancements for Insight. No functional impact and no end user actions needed.

For additional information on purpose, issues addressed, traceability matrix, and deviations please visit the OpenClinica 4 Stack 18.1.2 Note to File page here.

OpenClinica 4 Stack 18.1.1 (Release Date - 22 July 2023) OpenClinica 4 Stack 18.1.1 contains targeted updates to OpenClinica. View the entire Stack 18.1.1 changelog here (login required). For an overview of this update, view the Stack 18.1.1 Release Announcement here. Screenshots, overview information, detail breakdowns, and expected behavior can be found in both the Stack 18.1.1 Impact Analysis here and the 18.1.1 Detailed Log here.

Changes and Fixes:

Fixed an issue where files uploaded to the Data Transformation Module containing multiple periods were, when downloaded, having the site name appended to the filename in the wrong place. (OC-21140)

Fixed an issue preventing certain user roles from seeing eConsent statuses on the Participant Matrix when an eConsent form contained participant contact data. (OC-20879) Fixed an issue where duplicate eConsent Status columns were added to the Participant Matrix. Fixed an issue where duplicate eConsent Status rows were added to the Participant Details Page. This occurred after a Data Manager saved any site configurations. (OC-21075) Fixed an issue with the Study Audit Log Page where the view button hover text always displayed as "View" rather than using the user's OpenClinica study language. (OC-20899 Fixed an issue with Data Transformation Module download button hover text always displayed as "Download" rather than using the user's OpenClinica study language. (OC-20900) Fixed an issue where an extract job or extract dataset result table always displayed "Status" information in English rather than using the user's OpenClinica study language. (OC-20903) Fixed an issue with Data Review Table download button hover text always displayed as "Download current view" rather than using the user's OpenClinica study

language. (OC-20904)

Fixed an issue where downloaded Data Review Table files contained column headers in English rather than using the user's OpenClinica study language. (OC-20905) Fixed an issue where users experienced an error message when previewing forms in Form Designer. (OC-20919)

Fixed an issue where certain item group names for forms were missing from the study

metadata page in Study Runner. (OC-20956)

Resolved an issue where participant IDs were not shown on the View Events page. (OC-21065)

Fixed a data extract formatting issue with OpenClinica Extension ODM nodes, specifically OpenClinica:StudyDetails XML node. (OC-21079)

Resolved an issue where calendaring rules were not firing due to a lock on the participant's calendar. (OC-21124)

Fixed an issue where filtering on the SDV table could show incorrect results if there was a form that appeared in multiple events with different SDV settings. (OC-20897) Fixed a Participate issue where the Dashboard would not show any forms when a Participant's next forms to complete were in a visit containing many forms. (OC-21194)

Fixed a CRF version migration issue where the data incorrectly displayed on the "Confirm CRF Migration" page data mapping table. (OC-19330)

Security enhancements.

For additional information on purpose, issues addressed, traceability matrix, and deviations please visit the OpenClnica 4 Stack 18 Note to File - Stack 18.1.1 page here.

OpenClinica 4 Stack 18.1 (Release Date - 01 May 2023) OpenClinica 4 Stack 18.1 contains targeted updates to OpenClinica. View the entire Stack 18.1 changelog here (login required).

Changes and Fixes:

Fixed an issue causing slow Participant Details Page Visits section loading for studies with large query volumes and/or events with many forms. (OC-20910)

Fixed an issue preventing Unite from launching in some studies. (OC-20911)

OpenClinica 4 Stack 18 (Release Date - 29 April 2023) OpenClinica 4 Stack 18 contains targeted updates to OpenClinica. View the entire Stack 18 changelog here (login required). For an overview of this update, view the Stack 18 Release Announcement here. For more details about what this release means to you and your users, view the Stack 18 Impact Assessment here.

New:

Study Runner

Annotated Case Report Forms (aCRFs): Allows Data Managers to create individual blank annotated form PDFs and blank annotated Casebook PDFs which contain all forms in the study. Any form published to Study Runner can be downloaded as a PDF with annotations describing the form definition. This supports annotated forms needed for review during study design and as part of data submission or analysis after data collection. Individual annotated forms can be created from the CRFs page and annotated Casebooks can be created from a new page in Study Runner.

eConsent Module

eConsent: This new module allows Participants to sign Informed Consent forms with 21 CFR Part 11-compliant signatures. Investigators and CRCs can add 21 CFR Part 11-compliant countersignatures from the Participant Details Page. Provides new tools for tracking the

consent status of participants and an audit trail of all informed consent activity. PDF copies of signed eConsent forms can be downloaded by Participants as needed.

Study Calendaring Module

Study Calendaring: This new module provides new ability to use Form Action, Event Action, and Participant Action rules to automate Participant Calendars. The Participant Details Page is updated dynamically to reflect the results of the rules as they run. This allows study designers to make Forms editable, visible, and/or required based upon changes to Event data, Form data, and/or Item data in the study. In addition, Events can be scheduled, locked, or have their statuses change based on a data change. This functionality can be based on breaking your study into epochs, representing time periods within the study such as "Screening", "Treatment", and "Follow-up", and calendars representing different study arms or cohorts. This feature is available as a pilot with Stack 18, but is planned for general availability for Stack 19.

Changes and Fixes: Study Build System

Updated the Modules page to display the Unite - EHR Integration module with a Learn More link. Unite is available for clients to request, but will need to be configured for each study. (OC-17935)

Added new messaging to the Share, User Roles, and Administration pages to describe how changes to user roles and permissions are processed for users currently logged into Study Runner. (OC-20220, OC-20393, OC-20367)

Updated the Form Property label on the Study Designer Form Card from “Hidden” to “Hide from site users” to better align with the functionality. (OC-18460)

Updated the Data Dictionary to filter out items that are not present on any form version by default. (OC-19409)

Updated the Data Dictionary to show Form Properties, Participate Properties (if Participate is configured for the study), and Calendaring (if Study Calendaring is configured for the study) in the form-level header. (OC-18404)

Updated the header in the Data Dictionary to avoid unnecessary scrolling. (OC-17035) Fixed an issue that caused the Data Dictionary to split item labels that have commas into two separate columns and displayed quotes incorrectly in the Label field when downloading content. (OC-17306, OC-19628)

Fixed an issue that caused the Data Dictionary to display blank column versions on the user interface even though they would correctly display when downloaded. (OC-19726) Fixed an issue that prevented Form order changes to persist in Study Designer. (OC-17357) Added Accessibility Statement links to the User Menu in Study Manager and Study Designer. (OC-16629, OC-16628)

Fixed a server issue due to Study Designer not receiving final publish completion confirmation. (OC-20146)

Fixed an issue that prevented some users from being able to access Form Designer due to an error that made it appear as though users had duplicate usernames. (OC-20038) Fixed an issue that caused an error when trying to add a new question to the Library in Form Designer. (OC-20287)

Fixed a bug that was incrementing study revisions in Study Designer in some cases even when no study design changes were made. (OC-17490)

Improved performance of Study Designer for large studies. (OC-19580)

Study Runner

Fixed an issue that caused an error when attempting to sign a form in a non-repeating

common event that had more than one event occurrence (such as an event containing two forms). (OC-20675)

Removed access to the Enter or Validate Data For CRFs in Event page in Study Runner. Now, when a user clicks an event action button on the Participant Matrix, it will take the user to the corresponding event on the Participant Details Page. (OC-17688)

Updated the Participant Details Page to load on the All Records view when clicking View for a Removed Event from the Participant Matrix. The Participant Details Page will load with the Active Records view when clicking the View button on the Participant Matrix for an Event that is not Removed. (OC-18239)

When opening the Participant Details Page from the Participant Matrix through a referenced event, the search bar will automatically be cleared on the page load. (OC-20060) Updated Participant IDs in the Data Review Table to act as links to their associated Participant Details Page. (OC-18575)

Added the Verify action to the Form card action menu on the Participant Details page to allow Data Managers and Monitors to verify forms without going to the SDV page. (OC-17256) Updated the Form cards on the Participant Details page to include an icon for the Source Data Verification (SDV) status of the record. (OC-18352)

Added a Query bubble icon to form cards on the Participant Details Page for forms that have open queries assigned to any items in the form. (OC-17257)

Fixed an issue that prevented Common Events to load on the Participant Details Page when certain UTF-8 characters were in Visit Event names. (OC-16970)

Fixed an issue that caused the View form menu item to not display on the Participant Details Page within Locked or Frozen studies. (OC-20029)

Fixed an issue that allowed Study Viewer roles to edit the Participant ID on the Participant Details Page for studies using Manually Generated Participant IDs. (OC-20096) Fixed an issue where the Reassign menu option could inappropriately appear for Archived forms on the Participant Details Page. (OC-18661)

Updated the way study user roles and permissions are loaded during a user’s session to enhance security, improve page load times, and create consistency across the application. (OC-19166)

Fixed an issue that caused Event actions to be listed in the Participant Details Page menu when the study was in Design status. (OC-19055)

Fixed an issue that prevented display of Common Events on the Participant Details Page if a form in the event contained a comma in a choice name for a select_one item. (OC-19758) Fixed bug that brought user to Participant Details Page after removing or restoring an event from the Participant Matrix (OC-16748)

Fixed an issue causing the highlighting of recently accessed forms to disappear from the Participant Details Page earlier than expected.(OC-16752)

Fixed an issue where a Removed form that was also Hidden from the current user would cause the Participant Details Page to display a message indicating some forms were hidden in the active view. (OC-18341)

Fixed an issue that caused date filters to return incorrect results in the Common Events table on the Participant Details Page when there was a difference between the user’s time zone and the system time zone. (OC-19988)

Fixed an issue where embedded Insight reports on the Participant Details Page could sometimes cause an error when loading the page. (OC-18525)

Fixed styling of embedded Insight reports in Study Runner. (OC-13255) The Save button on the Site Configuration Page will now become disabled while a previous Save is still in progress. (OC-18596)

Updated the text on the Site Configurations page from “Hide CRF” to “Hide from users at this site” to better align with the functionality. (OC-18540)

Fixed an issue that could cause duplicate database entries to be created when selecting several form versions as available versions on the Site Settings page for forms with a large number of available versions. (OC-20075)

Updated the visibility of jobs in the Bulk Actions Log page to allow Data Managers to see all jobs that do not display clinical data in their results regardless of who ran them. (OC-16345, OC-19005, OC-19004, OC-19003, OC-19002, OC-19001, OC-19000) Updated the date format on the Bulk Actions Log page to be consistent with the date format throughout OpenClinica. The date format was Mon-DD-YYYY and was updated to be DD-Mon YYYY. (OC-19740)

Added tooltip hovertext to the Action buttons on the Bulk Actions Log page. (OC-13756) Updated Tabular Imports to allow the import of blank values. (OC-15472, OC-17281) Updated Tabular Imports to allow the use of the Update match action using EventRepeatKey in repeating common events. (OC-18178)

Updated the Submit button on the Import CRF Data page to be disabled and unclickable unless a file is selected. (OC-13718)

Reformatted the time stamp in the XML import log to include a time zone indicator. (OC-14293)

Canceling an XML import will now redirect the user back to the import page. (OC-19226) Fixed an issue that caused invalid date values on SPSS Extracts for date values that were entered and then changed to null. (OC-19787)

Reorganized the links to relevant Data Review Table entries that appear in Bulk Actions Logs for better clarity and readability. (OC-19123)

Updated the Data Review Table formatting by setting the maximum height for review table cells and freezing the Participant ID column. (OC-15223, OC-14854)

Updated the date format on the Data Review Table to be more consistent with the date format used throughout the system (DD-Mon-YYYY). (OC-16483)

Changed the sort behavior on the Data Review Table for columns with multi-select values to sort by their response option text rather than response values. (OC-15416) Fixed an issue that could cause the date picker on the Data Review Table to open in a way that prevented users from having the option of entering a date manually. (OC-15579) Fixed an issue that required some users to clear their browser cache before certain UI updates released as part of OpenClinica releases took effect for those users. (OC-19162) Updated the Data Review Table to include Removed/Not Removed as filter options within the Form Status and Event Status columns. (OC-15652)

Added a Download button to the Data Review Tables to allow users to download the table to review in another setting. (OC-18076)

Fixed an issue that caused query bubble icons to display incorrectly on the Data Review Table when multiple queries were on different items. (OC-15725)

Fixed an issue that caused the horizontal scrollbar to not appear when a filtered view of a Data Review Table displayed no results. (OC-19212)

Fixed an issue that could cause the Data Review Table to display inappropriately if the sort was enabled on a column item and that item was removed from the Data Review Table configuration. (OC-19340)

Fixed an issue that caused checkboxes to display on the Data Review Tables for Monitors even though the Monitors were unable to complete any action. (OC-18496)

Fixed an issue where Data Review Tables without data were showing an inappropriate error in browser consoles. (OC-19105)

Updated the Queries table to include only the “View Query within record” link for all Reasons for Change on the table. (OC-17265)

Fixed an issue that prevented queries from automatically closing when a form with a Permission Tag is archived. (OC-18570)

Fixed an issue that caused the Reason for Change entry to be omitted for Remove, Clear, and Restore form actions when the Queries Table is downloaded in CSV format. (OC-19601) Fixed an issue that prevented some queries from being auto-closed after the associated form was removed. (OC-20013)

Fixed an issue where having a Query on an empty Event End Date field could cause an error. (OC-18822)

Fixed an issue where the old and new values of item-level SDV status changes could appear as question marks in the Audit Log. (OC-18297)

Updated the behavior when a form is cleared and then edited in a different version what it had been set to. The form version in the database will now be changed when the form is opened regardless of when data is entered. (OC-20636)

Fixed an issue that caused Common Event status filters to return results for the expected German text and also the English equivalent when Study Runner is being displayed in German. (OC-19992)

Added missing German translations in Study Runner. (OC-19718, OC-19971, OC-19973, OC-20011, OC-20227, OC-20061, OC-19808)

Internationalization changes. (OC-20036, OC-19367, OC-20016, OC-19921, OC-19900, OC-20212)

Fixed an issue where contact module information was masked for CRC and Investigator. (OC-19887)

Fixed an issue that allowed the display of the “Add another occurrence” in the menu for repeating events on the Participant Matrix for Removed Participants. (OC-19014) Updated the Data Transformation Module to correctly display links to job results pages for all users who now have access to those job records. (OC-19043)

Updated the Data Transformation Module to allow persistent highlighting on the row with the action most recently taken. (OC-17799)

Added the option for users to add a description to files at upload in the Data Transformation Module. (OC-17324)

Fixed an issue where the Data Transformation Module did not display an error when a file upload to the queue failed. (OC-18393)

Added the ability to download an aggregated activity log that includes all of the actions performed on multiple files in the Data Transformation Module. (OC-18070) Added units to the header of the file size column on the Data Transformation Queue. (OC-17710)

Added a divider between locked and scrolling columns on the Data Transformation Queue. (OC-18139)

Fixed an issue where date item values displayed in the audit log could have a different format than when displayed in the form. (OC-19541)

Added the ability to download the Data Transformation Queue table. (OC-19190) Added the ability to Restore/Reject files in bulk from the Data Transformation Module. (OC-18149)

Fixed an issue causing inconsistent display of filter options in the Data Transformation Queue. (OC-20111)

Changed the “View Log” button in the Data Transformation Module to create a popup. (OC-18110)

Updated the downloadable filename from the Data Transformation Module to include the site name. (OC-19875)

The field to enter a description when uploading a file to the Data Transformation Module now correctly displays transparent placeholder text. (OC-19099)

Fixed an issue where a Site Data Manager was unable to filter by site in the Data Transformation Module. (OC-20379)

Fixed an issue where Data Transformation Module file uploads were failing in some cases due to email connectivity issues. (OC-20378)

Data Transformation Module dialogs will now only display error messages if the user attempts to confirm their pending action. (OC-18884)

Clicking “Go Back” from the Bulk Actions Log when viewing a Data Transformation Module related job now returns the user to the Data Transformation Module page, rather than the main Bulk Actions Log page. (OC-18673)

Updated the Tasks menu to allow it to collapse when it is no longer being hovered over. Previously, the Tasks menu would remain open indefinitely when viewing certain pages. (OC-12188, OC-19104)

Fixed an issue that caused an inconsistency in color of the asterisk [*] indicating Required fields on some pages in Study Runner. The asterisk would show in black on some pages, but it has been updated to display correctly in red on the following pages: Update Study Event, Create Dataset, Create Scheduled Job, End Date: Add Query, Start Date: Add Query, Remove Event from Study, Remove Form from Event, Clear Form from Event, Restore Form to Event, Remove Participant from Study, Restore Participant to Study. (OC-19634)

Fixed an issue that caused events to remain Signed when the Event Status was updated. (OC-20069)

Fixed an issue allowing Run on Schedule Rules to still fire and send notifications for Removed Participants. (OC-13430)

Fixed an issue where a rule that did not explicitly list all possible event workflow statuses in the RunOnStatus node of the rule definition could unexpectedly fail to fire. (OC-19029) Fixed an issue preventing all rules in study from being included in the rules download. (OC-14536)

Fixed an issue causing rules to fire when the target for the rule was removed. (OC-18033) Fixed an issue that allowed Participants at Locked or Frozen Sites to be signed by Data Specialist users accessing at the Study Level. (OC-18533)

Fixed an issue that prevented Casebook PDFs from displaying the images for Signature and Drawing item types. (OC-18829)

Fixed an issue where the PDF Casebook could be missing some repeating groups entries on a form if there were deleted entries and the form definition used repeat_count. (OC-19831) Added an update to prevent PDF Casebooks with very large forms from failing due to timing out. (OC-20613)

Fixed an issue where canceling an individual form version migration action could return to the user to the wrong page. (OC-19009)

Fixed an issue that prevented the restoration of a participant from the Participant Matrix while in the Single Event view. (OC-19007)

Improved performance of View Events page for large studies. (OC-18664)

Fixed an issue that could cause Scheduled Extract Jobs to fail to run based on the status of the user who is configured to be notified when the job runs. (OC-20052)

Updated Scheduled Extract Jobs table sorting to persist after actions are performed. (OC-12833)

Improved loading times for the View Events page in studies with many events. (OC-18664) Fixed an issue where a form version could be made a default form version at a site without that form version being available to users, which prevented users from accessing the form. (OC-19708)

Fixed an issue where the preserved files from past runs of scheduled extract jobs could sometimes fail to delete properly if they included forms using permission tags. (OC-20542)

Forms

Updated the form Complete button to give users the option to add automatic queries for standard soft constraint and required edit checks when a form is marked Complete. (OC-12769)

Updated previously cleared forms to populate item default values the first time a cleared form is edited again. (OC-14456)

Fixed an issue that allowed forms to be opened in Review-only mode instead of Read-only mode when a study was still in the Design status. (OC-14919)

Fixed an issue that allowed Participants to complete a form with a blank signature widget item even though the item was defined as required. (OC-19319)

Fixed an issue that caused Select items with a choice filter in repeating groups to show incorrect values in View mode. (OC-16586)

Fixed an issue that caused an error when opening a form in a View mode for forms with a repeating group that uses repeat count and had deleted repeating group entries. (OC-18086) Fixed an issue where tabbing out of a date field in a form could result in the value being set inappropriately. (OC-19442)

Fixed an issue that only allowed users to select increments of 10 when using a visual analog scale item with appearance “analog-scale vertical show-scale”. (OC-19690) Fixed an issue that was preventing the progress bar to persist once in offline mode. (OC-18091)

Fixed an issue preventing the opening of forms with data that were previously in a non repeating event and are now in a repeating event. (OC-18122)

Participate

Fixed an issue that prevented Participants from editing forms if they were reassigned to a new site and their old site was Locked. (OC-19447)

Added Accessibility Statement and Privacy Policy links to the User Menu in Participate. (OC-16630)

REST API

Clarified the API parameter description to the swagger GET API Participant call to give the user more information. (OC-19693)

Improved performance of the Bulk Study Event API call that could cause it to prevent user access to Study Runner. (OC-19985)

Insight

Updated Insight user interface to provide an improved navigation experience for users and admins. (OC-20279)

Fixed a variety of issues related to Insight email notifications containing data in a different format than the Insight user interface. (OC-20279)

Updated Insight to include compatibility with eConsent by including the new statuses, event types, and a new standard question. (OC-18959, OC-20340)

General

Updated the white icon on the orange help widget from a question mark to a broadcast icon. (OC-20114)

Security enhancements.

OpenClinica 4 Stack 17.4.1 (Release Date – 09 March 2023) OpenClinica 4 Stack 17.4.1 contains targeted updates to OpenClinica. View the entire Stack 17.4.1 changelog

here (login required).

Changes and Fixes:

Fixed an issue that caused Visit Events to be scheduled for the wrong day if they were added from the Participant Details Page during February for the 29th, 30th, or 31st day of another month or during April, June, September, or November for the 31st day of another month. (OC-20351)

Fixed an issue that could cause Casebook PDF failures for forms with very large data sets due to a timeout issue. (OC-20464)

OpenClinica 4 Stack 17.4 (Release Date - 21 January 2023) OpenClinica 4 Stack 17.4 contains targeted updates to OpenClinica. View the entire Stack 17.4 changelog here (login required).

New:

Study Runner

Internationalization: Study Runner and Forms opened from Study Runner can now be displayed in different languages based on study configuration and a user’s browser locale settings. Initially, English (en) and German (de) are the supported languages.

Unite

Additional Data Domains: Participant Immunizations, Encounters, Conditions, and Procedures data can now be sent from the Cerner EHR to OpenClinica using Unite. This expands the existing ability to send patient EHR data including Labs, Medications, and Demographics to OpenClinica.

General

Qualification Report: The most recent UpOQ report can now be downloaded from within OpenClinica using a button on the Administration page. The report layout and style have been updated to present the information in a cleaner, more concise format. For customers using Insight, Insight UpOQ reports will continue to be provided separately.

Changes and Fixes:

Study Runner

Fixed an issue that caused Common Event form table search on the Participant Details Page to return unexpected results for some text in the Form Status column. (OC-19515) Fixed an issue that caused version reassignment for non-repeating Common Event forms to fail from the Participant Details Page. (OC-19583)

Fixed an issue that allowed the Common Event Add New button on the Participant Details Page to remain active after being clicked. This could result in duplicate form records being created. (OC-19101)

Fixed an issue on the Participant Details Page causing form tables for Archived Common Events to not be displayed in some cases when the record filter is changed while using the page. (OC-19512)

Fixed an issue on the Participant Details Page that caused Common Event form tables to highlight an incorrect row after adding a form while the record filter was set to show Removed

records. (OC-19537)

Fixed an issue that prevented a Common Event section from loading correctly on the Participant Details Page if a Common Event form table was configured to show a column for a select_multiple item which had more than 50 choices. (OC-19547)

Fixed an issue that caused Common Event form table search on the Participant Details Page to return no results if the search term contained a leading or trailing space. (OC-19517) Improved performance of generating PDF Casebooks for Participants with any forms. (OC-19647)

Fixed an issue which caused access to some forms to be restricted as if they contained contact data even when they did not. (OC-19540)

Fixed an issue that allowed Site-level Data Managers to see the list of all Sites in the study when viewing the Study metadata in Study Runner. (OC-19507)

Changed the job run frequency option on the Scheduled Extract Jobs pages from “Monthly” to “Every 4 Weeks” to describe the existing functionality more accurately. (OC-19361) Fixed an issue where Scheduled Extract Jobs set to trigger daily could sometimes stop triggering after the first day. (OC-19810)

Fixed an issue that allowed a user to open a form in edit mode from Data Review Tables when the version the form was using was archived. (OC-19344)

Fixed an issue that prevented some data from archived forms from being displayed on Data Review Tables. (OC-19483)

Added additional options to the Data Transformation Module filters for the Pipeline, Uploaded By, Transformed By, and Imported By columns. (OC-19196)

Data Transformation Module file upload notification emails are now sent to Study Monitors as well as to Data Managers. (OC-19125)

Updated the Data Transformation Module permissions to permit Site-level Data Managers to use the same functionality as Study Data Manager, but only for files at their own site. (OC-19482)

General

Security enhancements.

Click here to view previous updates.

Functional approval by Paul Bowen. Signed on 2024-12-07 11:57AM

Approved for publication by Brooke Davis. Signed on 2024-12-07 11:59AM

Not valid unless obtained from the OpenClinica document management system on the day of use.