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OpenClinica 4 Stack 19.0.3 (Release Date – 11 May 2024)

OpenClinica 4 Stack 19.0.3 contains targeted updates to OpenClinica. View the entire Stack 19.0.3 changelog here (login required). For an overview of this update, view the Stack 19.0.3 Release Announcement here.

Changes and Fixes:

  • Study Build System
    • Fixed an issue that prevented new form versions from being added if an attempt to add one failed and was not later completed successfully. (OC-22483)
  • Study Runner
    • Fixed an issue that caused the Participant Details Page Visits section to fail to load and the study environment to fail to refresh in Insight in the special case where a form was in a cleared state in a different form version from the current default version. In that case, opening the form in Edit mode and Completing it without any data entry or opening it in View mode caused an empty duplicate form database entry to be created. (OC-22523, OC-22765)
    • Fixed an issue that attributed a form version change to a user who viewed a form in the special case where a form was in a cleared state in a different form version from the current default version. In that case, opening the form in View mode caused an audit entry to attribute a form version change to a Viewer or Monitor who viewed the form. (OC-22695)
    • Added preventive database constraints to ensure duplicate form records are not created in the event of unexpected system behavior in the future. (OC-22672)
    • Fixed an issue that prevented form version migration on a form record if there was an open query on an item that was not included in the new form version. (OC-22548)
    • Fixed an issue where Study Calendaring actions did not execute for Participants created by submitting a Public URL form. (OC-22651)
    • Fixed an issue that prevented Public URL form submission if the form included contact data items. (OC-22470)
    • Updated Archival Casebooks to include Participants with a status of Signed in all cases. (OC-22635)
    • Updated Data Transformation Module for pipeline compatibility with AWS Lambda and Python updates. (OC-22518, OC-22585)


OpenClinica 4 Stack 19.0.1 (Release Date – 16 March 2024)

OpenClinica 4 Stack 19.0.1 contains targeted updates to Study Runner. View the entire Stack 19.0.1 changelog here (login required). For an overview of this update, view the Stack 19.0.1 Release Announcement here.

Changes and Fixes:

  • Study Runner
    • Fixed an issue that prevented study-level users from extracting data from forms hidden from site-level users. (OC-22417)

For additional information on purpose, issues addressed, traceability matrix, and deviations please visit the OpenClinica 4 Stack 19.0.1 Note to File page here.


OpenClinica 4 Stack 19  (Release Date – 16 March 2024)

OpenClinica 4 Stack 19 contains broad updates to OpenClinica. View the entire Stack 19 changelog here (login required). For an overview of this update, view the Stack 19 Release Announcement here. For more details about what this release means to you and your users, view the  Stack 19 Detailed Log here or the Impact Analysis PDF Document here.

New:

Study Calendaring Module

  • Study Visit Windows: New functionality in Study Designer allows Data Managers to define visit windows for auto-scheduling and auto-closing non-repeating visit-based events. Automatic scheduling and closing of visit events can be triggered based on visit status, time windows, or Participant creation. Time-specific actions will respect the Participant’s site’s time zone configuration.  These calendaring actions are published to Study Runner as part of the study publishing process. This functionality streamlines the scheduling of non-repeating visit-based events from Participant creation to closeout, eliminating the need for manual intervention. It will be extended in future releases and is intended as a replacement for the legacy Rules that are configured directly in Study Runner. Legacy Rules should be removed before publishing similar scheduling actions from Study Designer.
  • Sending Notifications: New functionality in Study Designer allows Data Managers to define email and SMS notifications for non-repeating visit-based events. These notifications can be sent to Participants or any predefined email addresses. They can be sent upon event creation or completion, as well as before or after the event’s start date. Multiple notifications can be set up for an event, each configured to be sent at a specific time of day and respecting the Participant’s site’s time zone configuration. These notifications are published to Study Runner as part of the study publishing process. This functionality will be extended in future releases and is intended as a replacement for the legacy Rules that are configured directly in Study Runner. Legacy Rules should be removed before publishing similar notification actions from Study Designer.
  • Site Time Zone: Added ability for Data Managers to define the site time zone when adding a site or editing a site on the Share page. A new column on the Sites table shows the current time zone setting for each site. This time zone applies to all participants assigned to that site. Currently, the Time Zone feature is used for automated scheduling and closing of events, and notification features. However, the Time Zone feature will be expanded in the future. The default time zone for each new and existing site is UTC.

Study Runner

  • Participant PDF Casebook: Enhanced Participant PDF Casebooks to include a casebook cover page, table of contents, and a cover page for each form containing study, site, and event information. Additionally, updates were made to the headers and footers of the casebook. The forms in the Participant Casebook are now in chronological order by event start date rather than in study definition order. Finally, study-level users have an option to include forms hidden from the site within the PDF casebook.
  • Archival Casebook: Added new capability for Admin Data Managers to create Participant PDF Casebooks in bulk at the study-level or site-level using the new Archival Casebooks feature. Archival Casebooks contain a Participant PDF Casebook file for each Participant in the study or site, optionally including removed participants and forms hidden at sites. Each Archival Casebook .zip file contains an overall summary report and site-level summary reports. If a Participant has no form data or the Data Manager does not have permission to view any of the Participant’s data, the Participant PDF casebook will contain the message “This participant does not have any forms or the user who generated this does not have permission to view any of the participant’s forms.” to reflect both scenarios. Archival Casebook jobs appear in the Bulk Actions Log and can be canceled before completion when needed.
    • Note: This feature is only available to users with Admin user type and Data Manager user role in the study.
  • Blank Casebook: New functionality allows Study Runner users to generate a Blank Casebook for a study or site. Each Blank Casebook contains a PDF file with a cover page, table of contents, form cover pages, and a blank copy of each form. The Blank Casebook compiles the study’s or site’s default version of each active form, collates them by event, and creates a single PDF file for download. Blank Casebook jobs are shown in the Bulk Actions Log.

Participate Module

  • Participant Workflow: Improved Participate to help ensure data completeness of Participant forms and provide Participants with more options for long forms. The “Let’s Move On” option to complete all of Participant’s forms in an event and move on to the next event, can now only be accessed if the Participant closes the form via the “I’m done” button (which was previously labeled “Submit”), after completing all required fields. In case the user needs to exit the form and continue data entry later, we have added a “Finish Later” button to each page of the form. This ensures that if the Participant starts the form but closes it without completing all required fields, they will not be able to submit the form and move on.
  • Form and Event Descriptions: Form and Event Descriptions added in Study Designer can now be configured to appear in Participate and eConsent so that Participants can have more context for their tasks. A checkbox is available in Study Designer, in both event and form cards, to control display of the descriptions to Participants. Form descriptions will now also appear in the CRF metadata table on the View Study page in Study Runner.

Changes and Fixes:

Study Build System

  • Fixed an issue on the User Roles page in Study Manager where user role lists did not update when a permission tag name was updated in Study Designer. (OC-9564)
  • Add text to inform the user that usernames cannot be changed once created. The text “(note: this cannot be changed after the user is created)”, appears next to the Username field when adding a new user on the Share Page in Study Manager. (OC-21690)
  • Improved performance of Publish history table on the Share page in Study Manager. (OC-20817)
  • Fixed an issue where deactivating a user in rare cases did not record the deactivation in the audit log, although the user was correctly deactivated. (OC-19480)
  • Fixed an issue where creating a new permission tag in Study Designer incremented the study revision number even when the tag was not yet assigned to any forms. In this case there is no change to the study design unless the permission tag is assigned to a form. (OC-20302)
  • Improved reliability of Study Designer in saving updates made in very large studies. (OC-21445)
  • Updated Study Designer to allow users to upload form definitions including CSV files greater than 1MB. (OC-21134)
  • Updated form definition upload in Study Designer to ensure that forms are not treated as containing contact data items inappropriately. Specifically, if a form version is updated and the form no longer has any versions with contact data items, the form will not be treated as containing contact data. (OC-18719)
  • Fixed an issue where Study Designer became blank when dragging cards to events that are offscreen/out of the user’s current view. (OC-17763)
  • Fixed alignment and wrapping issues on event cards in Study Designer. (OC-20288)
  • Improved performance for configuring Data Review Tables in Study Designer for large studies. (OC-20870)
  • Fixed an issue where form or event names containing a colon (:) could cause item names to be cut off on the Data Review Table configuration interface in Study Designer. (OC-20878)
  • Updated Study Designer form definition upload to improve validation of eConsent form definitions. (OC-20226, OC-20565, OC-20321)
  • Updated Study Designer to allow a non-eConsent form version to be uploaded as a replacement for an eConsent form version if that is the only form version available for that form. (OC-21077)
  • Updated Form Designer so Data Managers can configure eConsent forms in Form Designer. (OC-17484)
  • Fixed an issue in Form Designer that prevented users from previewing forms if the form name exceeded 36 characters. (OC-21279)
  • Fixed an issue preventing users from creating a new collection in the Form Designer Library Management interface. (OC-21456)
  • Updated the Form Template to reflect changes in Stack 19 (instructions for new contact data items and custom annotations). (OC-22057)
  • The error message displayed when an attempt to publish fails due to an issue in eConsent form configuration will now more clearly indicate the corrective action needed to publish successfully. (OC-20600)
  • Improved study publishing stability and reliability. (OC-20597)
  • Improved performance of study publishing. (OC-21719, OC-22110)
  • Fixed an issue where the Study Calendaring Rules Management page did not correctly show the rules configuration dropdown display.  (OC-20643)

Study Runner

  • Participant Details Page (PDP)
    • Improved load time for the Participant Details Page Visits section if “Show Active” (the default) or “Show Removed” records is selected for the record filter. (OC-20912)
    • Added functionality to the Participant Details Page to allow the Visits section to update dynamically to reflect incremental changes in the records while the page has been open (such as from Calendaring actions firing). (OC-19905)
    • Updated form cards in the Visits section of the Participant Details Page to indicate forms configured to be completed by Participants with a new icon. (OC-20831)
    • Updated Participant Details Page Visits section default action for Participate forms. When a user clicks the form card the form will open in View Mode by default regardless of form status. (OC-21234)
    • Fixed an issue where the count of results in filtered Participant Details Page views included forms hidden from the current user. (OC-21096)
    • Fixed an issue on the Participant Details Page where users could schedule a Visit event with an Event End Time, but no Event End Date provided. (OC-20888)
    • Fixed an issue where the Participant Details Page did not set the correct default filter in some cases. The correct default filter is “Active Records”. (OC-19818)
    • Fixed an issue where the Participant Details Page would sometimes load without the most recently used filter settings persisting as expected. (OC-21173)
    • Added the ability to verify Common Event forms for SDV directly on the Participant Details Page. (OC-20917)
    • Updated Participant Details Page Common Event search functionality to support searches using the character “+”. (OC-19529)
    • Updated Participant Details Page Common Events table text to correct capitalization and alignment inconsistencies. (OC-16552, OC-17232)
    • Added an option on the Participant Details Page to download the Participant’s CDISC ODM XML casebook rather than view it directly within a browser. (OC-21366)
  • Queries
    • All system actions, such as system-generated queries, previously attributed to user “root” will now be attributed to “system” when they next occur. This update does not affect audit entries for actions that occurred in the past. (OC-20683)
    • Fixed an issue where the Queries Table was missing the Assigned User value for system-generated queries when the user was accessing Study Runner in German. (OC-20734)
    • Updated the Queries Table CSV and PDF download functionality to include the “Item Type” column as shown in the browser. (OC-20683)
    • Improved performance when downloading the Queries table as a CSV file. (OC-15113)
    • Updated the Reason for Change required field asterisk [*] color to red when removing or restoring forms, events, or participants.  (OC-19634)
  • Extract Data
    • Fixed an issue where scheduled extract job filenames contained the incorrect job run date if the job had been edited after it was created. (OC-19826)
    • Fixed issues where actions to delete and remove jobs worked intermittently (OC-21192)
    • Improved performance of data extracts when the study’s forms use permission tags. (OC-20787)
  • Investigator Signatures
    • Fixed an issue where republishing a study with archived events that were already archived in Study Runner would cause Participants with those events to be unsigned. Only a publish action that changes an event from active to archived is expected to unsign Participants. (OC-22103)
    • Fixed an issue that prevented Investigator users from accessing the Participant audit log via the participant signature page. (OC-21718)
    • Updated text on the ‘Sign Participant Page’ for clarity and usability. (OC-21711)
    • Improved performance when bulk signing large numbers of Participants. (OC-21443)
  • Source Data Verification (SDV)
    • Fixed an issue on the Source Data Verification (SDV) page where the page numbers did not match the number of rows if there were hidden forms at a site. (OC-21172)
  • Data Review Tables (DRT)
    • Updated the Participant ID column in Data Review Tables to use the same text sort algorithm as the Participant ID column in the Participant Matrix. (OC-15309)
    • Updated Data Review Table functionality to include a participant site column. This column can be filtered and used for sorting. (OC-15248, OC-21632)
    • Updated the Data Review Table download functionality to include event and form statuses like locked, signed, removed, and archived. These statuses enable users to identify and review specific data based on the event statuses within the table. (OC-20931)
    • Improved Data Review Tables (DRT) to allow users to filter for records with open Queries, making it easier to close Queries in bulk directly from the DRT. (OC-20021)
    • Increased the maximum number of rows that can be displayed on a single page in a Data Review Table (DRT), allowing bulk actions to be performed on more records at once. (OC-20022)
    • Data Review Tables (DRT) now have a “Select All” checkbox on each column to allow bulk selection of all instances of a particular item. This enables bulk closing of Queries for that item. (OC-20023)
    • Fixed an issue in Data Review Tables where deselecting the checkbox for the only item cell in a row did not also fully deselect the row-level checkbox. (OC-20554)
    • Fixed an issue where filtering items in the data review table did not work as expected when filtering a column with multiple special characters (OC-19629)
    • Updated Data Review Tables to include labels for select_one and select_multiple items in addition to their database values when downloading the table. For example, if you have an item show on the form as “Yes” with a stored value of “Y”, both values will show in the downloaded file. (OC-21618)
    • Fixed an issue were clicking on links for form items in a Data Review Table did not work if the Data Review Table contained multiple common event forms. (OC-16743)
    • Fixed an issue where Data Review Table links to secondary form items that were in Common Events did not open the source form as expected. (OC-20668)
    • Fixed an issue where queries were missing from Data Review Tables in rare cases. (OC-20607)
    • Fixed an issue where unwanted and non-functional check boxes appeared on Data Review Tables in certain scenarios. (OC-20863)
  • Annotated Casebooks
    • Fixed an issue where line breaks within Required, Relevant, Calculation, Default and other form item attributes that contain logical expressions broke Annotated CRF formatting. (OC-20918)
    • Added the title “Annotated Casebook” to Annotated Casebooks’ title pages to help differentiate them from Blank Casebooks and Participant Casebooks. (OC-20270)
    • Added option to generate Annotated Casebook for a specific site. (OC-20518)
    • Applied standard file naming format to Annotated Casebook job files. Previously the file name started with Study Name and now uses Study ID instead. (OC-21625)
  • Bulk Actions Log
    • Updated the Bulk Actions Log column header “Completion Time” to be renamed as “End Time” to reflect that some jobs may end in failure. (OC-21005)
    • Fixed an issue on the Bulk Actions Log where Participant PDF Casebooks or Annotated Casebooks that had failed to generate successfully would sometimes not allow the user to download or view the error log. (OC-20458, OC-20461)
    • Updated error messaging for failed jobs on the Bulk Actions Log to display the error message from the server, followed by “Contact your administrator if this persists.” (OC-20481)
    • For data import jobs that also include running form logic, Data Managers can now see BACKGROUND_FORM_PROCESSING jobs in the Bulk Actions Log regardless of which user initiated the data import job. This provides greater visibility into the status of data import jobs. (OC-21742)
  • Data Transformation Module (DTM)
    • The Data Transformation Module Queue now allows filtering and sorting by file type. (OC-20799)
    • Files with no extension in their name will now appear with a “File Type” of “None” in the Data Transformation Module Queue. Previously they were labelled as “txt” files. (OC-20802)
    • Data Transformation Module import jobs that fail due to mapping file errors now produce an appropriate error message based on the import error returned. (OC-20832)
    • The name of the current mapping file used by each pipeline is now shown in the Transform menu when selecting a Data Transformation Module pipeline. (OC-20833)
    • The Data Transformation Module now provides the option to automatically extract the contents of .zip files and other types of file archives upon upload to the Queue. (OC-20925)
    • All email notifications generated by the Data Transformation will now include an indication of whether they are being sent by the Production or Test environment of the study. (OC-21694, OC-20372)
    • Study Viewers can now download the Data Transformation Queue table. (OC-20404)
    • Fixed an issue where a Site Data Manager actively using the Data Transform Module could be logged out of Study Runner if their user role were changed. (OC-20760)
  • Rules
    • Fixed an issue where Study Runner permitted users to upload invalid Notifications Action Rules based on item data changes instead of event level attribute changes. (OC-17142)
    • Fixed an issue where Notification Action rules failed to execute when the target event’s status changed. (OC-21440)
  •  Miscellaneous
    • Fixed an issue where, after using OpenClinica for over 4 hours in a single login session, users would receive errors on some Study Runner pages until they logged out and then logged back in. (OC-18069)
    • Fixed an issue where Participant IDs containing a “.” caused some of the expected Event action options to be missing from the Participant Matrix single event view. (OC-19949)
    • Fixed an issue affecting Locked and Frozen sites where the wrong action icon was displayed for events on the Participant Matrix. (OC-20149)
    • Fixed an issue were initiating a large data import sometimes prevented users from logging into OpenClinica until the import was complete. (OC-21552)
    • Fixed an issue were Tabular Data Imports allowed non-existent dates, for example April 31st, to be imported without error. (OC-21489)
    • Fixed an issue were importing data for Participants with an ID containing “\” or “/” failed. (OC-20448)
    • Fixed an issue where removing an Event was not updating the Last Modified date/time for a Participant. (OC-20960)
    • Added a timestamp to the Participant Audit Log filename. (OC-16799)
    • In studies where non-English language settings are enabled, language translations have been added or updated including for participant invitations, the user login page, eConsent text, the eConsent counter-signature page, and form statuses in the audit log. (OC-19528, OC-19898, OC-20070, OC-20204, OC-20205, OC-20206, OC-21347, OC-21558)
    • Reorganized links in Data Manager’s Tasks Menu. Under the Monitoring and Managing Data Tasks section, when accessing a specific site, the order was changed to be consistent with the study-level display. (OC-20018)

Unite

  • Fixed an issue to make launching OpenClinica Unite more robust. (OC-21437, OC-21411)
  • Fixed an issue where “Last Pulled” relative time for resources was not updating on screen in Unite. (OC-22145)
  • Fixed a UI bug with the Medication Start Date item for Unite. (OC-21578)
  • Fixed a bug with Gender at Birth data pull for the Unite Demographics feature. (OC-21548)
  • Updated Unite data pulls for Demographics, Medications, Medication Start Date, and Gender at Birth value to be compatible with the newer FHIR versions. (OC-20786, OC-19930, OC-20786)
  • Fixed an issue that prevented very large Participant datasets from being pulled from an EHR to OpenClinica using Unite. (OC-21334)
  • Added the ability to retrieve data for Conditions, Immunizations, and Procedures using OpenClinica Share (iOS app). (OC-19978, OC-20042, OC-19752)

Forms

  • Fixed an issue where forms could pull in incorrect cross-form values in rare cases of simultaneous usage of the same form for different Participants. (OC-21989)
  • Fixed an issue were generating PDF forms with Visual Analogue Scale (VAS) items did not show the central line or tick marks in the PDF as they were displayed on the screen. (OC-20423)
  • Fixed an issue where a user opening a form in Review-Only Mode and adding or responding to a query caused the text “You’re in review-only mode” to disappear. (OC-20784)
  • Fixed an issue with Queries rendering incorrectly within forms when the query text contained special characters such as / or ‘. (OC-20246, OC-21847)
  • Fixed an issue where form definitions with filenames containing the letters “api”, including in external list or media files, could not be opened correctly. (OC-16598, OC-17116)
  • Improved performance of running all background form logic and form PDF actions. (OC-21352)

Participate

  • Fixed an issue where an erroneous US Government access message was shown to Participants logging in for customers with SAML authentication enabled for site-level and study-level users. (OC-21628)
  • Updated secure PII handling to support new contact data items: Street Address 1, Street Address 2, City, State, Postal Code, Country, Middle Name, Date of Birth, and Hospital Identification Number. When configured appropriately within forms, these fields are securely stored in a separate encrypted database table that is accessible only to CRC and Investigator users. (OC-20552, OC-21891, OC-21898, OC-21883)

eConsent

  • Updated Participant Details Page General Information section to dynamically reflect eConsent status changes. (OC-20658, OC-20843)
  • Updated Participant Matrix column name from Participate Status to Invitation Status when eConsent is active but Participate is not active. (OC-21159)
  • Fixed an issue on the eConsent Countersign Form page where the query count listed for the form was incorrect. (OC-20697)
  • Updated the text used to mask PII in Participant eConsent signatures to “<Masked>” for consistency with other Study Runner functionality. (OC-20849)
  • The PDF copy of an eConsent form generated when a Participant signs it will now be available for download on the Participant’s Dashboard automatically without requiring a manual page reload. (OC-21067)
  • Added “version” label for eConsent PDFs listed on the participant’s dashboard to make it clear to the participant what the version number is referring to. (OC-20323)
  • Updated error messages that could appear when a Participant attempted to reset their Access Code for eConsent to remain visible until cleared manually instead of disappearing after a short time. (OC-21997)
  • Updated text for resending Access Codes to participants via SMS to support easier copy/paste of the Access Code across all mobile operating systems. (OC-21550)

Insight

  • Added an opt-in feature to enable fully integrated user role and permission tag-based data access in Insight. (OC-10416)
  • Added an optional link to Insight to the Tasks Menu in Study Runner. The presence of this link can be configured per user role for each study. (OC-18828, OC-21196)
  • Fixed an issue where attempts to download an Insight Question’s results could fail if the user accessed the Question via a link from a Dashboard but lacked Unrestricted access to the study’s data mart in the Insight permission settings. (OC-21868)
  • Fixed an issue in Insight where columns could not be reordered in questions with large numbers of groupings and hidden columns. (OC-22086)
  • Updated Insight UI to include the ability to break dashboards out into multiple tabs. (OC-21868)
  • Updated Insight UI to include the ability to add automatically formatted links to Dashboards. (OC-21301)
  • Updated Insight UI to include the ability to download entire Dashboards or individual charts/tables as PDF or PNG files. (OC-21301)

REST API

  • Fixed an issue where API tokens issued to users did not immediately become invalid when the user was removed from the study. (OC-20676)
  • Fixed an issue where users were unable to use the PDF Casebook API unless they were not logged into the same study in their browser. (OC-21665)
  • Added Participant API endpoint to retrieve data for a single participant even when Participate Module is not being used. (OC-20812)
  • Fixed an issue were creating the first Participant for a new site via API in a study using system-generate Participant IDs would skip the expected first Participant ID. (OC-21801)
  • Fixed an issue where Participant contact data added via API could be misattributed in the audit log to the user who had created the participant. (OC-22265)

General

  • Added help icons linking the user to context-specific pages of OpenClinica’s documentation site throughout the OpenClinica user interface, such as Study Runner, Study Designer, and other pages. Note that some of the new documentation pages will be placeholders until new content is published. (OC-20788, OC-20789, OC-20791, OC-20792)
  • Added announcement icon to user login page so that users can access system announcements prior to logging in. (OC-20759)
  • Added user-friendly error messaging for users when SAML login fails due to customer certificate expiration. (OC-20761)
  • Security enhancements.

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