OpenClinica 4 Stack 11 (Release Date – 29 January, 2020)

OpenClinica 4 Stack 11 contains a variety of enhancements and fixes to OpenClinica. View the entire Stack 11 changelog here (login required). 

For an overview of the update, view the Stack 11 Release Announcement here.

Highlights include: 

New: 

Runtime

  • Added the ability to generate printable Participant Casebooks. There is a link at the bottom of the Participant Details page to generate a PDF Casebook including all the Participant’s Forms that have data (including history and queries).
  • Added the ability to use random numbers in system-generated Participant IDs. Updated Site ID to be optional in system-generated IDs.

General

  • Added support for Multi-Factor Authentication, which can now be enabled for all studies at the customer-level. With this enabled, all non-Participant users logging into OpenClinica are required to provide a dynamic access code.

Changes & Fixes: 

Study Build System 

  • Fixed an issue that could cause an error when publishing a study that contained Form versions including items with names that had been used in other Form versions but had been removed from the other Form versions when those versions were overwritten. (OC-9428)
  • Fixed an issue where a study would fail to publish if new Form versions changed the case of item or item group names. (OC-10602)
  • Fixed an issue that was sometimes allowing Forms with duplicate item or itemgroup OIDs to be created, which could prevent the study from publishing. (OC-11845)
  • Improved the study publication workflow by preventing publication of a study environment while a previous attempt to publish that study environment is still being processed, which could result in errors and decreased performance. (OC-10523)
  • Fixed an issue that could cause failed attempts to publish a study to induce errors in future attempts to publish the study. (OC-11929)
  • Fixed an issue where a study could fail to publish if it contained an archived Event that included a Form without a Form version defined for it. (OC-11718)
  • Fixed an issue where having an archived Common Event in a study that includes an overwritten Form version could cause the study to fail to publish. (OC-11676)
  • Fixed an issue where configuring custom columns in the Participant Matrix or Queries table to display items from a Form and then updating that Form to a version that does not include the items configured for the custom columns could prevent the study from publishing. (OC-11675)
  • Added a link to the Publish History section at the top of the Share Study page. (OC-11122)
  • Added help text to the interface for configuring system-generated Participant IDs. (OC-12024)
  • Study names and descriptions can now correctly include up to 255 characters. (OC-11024)
  • Improved performance on the Study Settings page. It will now immediately reflect updates made to Study Type and Phase. (OC-11704)
  • Fixed an issue that could cause the Modules configuration page to display incorrectly. (OC-11197)
  • Added the ability to export the Activity Log from Study Designer, enabling Data Managers to examine a record of all the changes that have been made to a study design. (OC-10777)
  • Fixed an issue that could sometimes cause the Activity Log to fail to load fully in Study Designer. (OC-11686)
  • Updated the error message displayed when an invalid itemgroup is included in an uploaded Form Template to be more user-friendly. (OC-11625)
  • Fixed an issue that could cause changes to Form order in Study Designer to revert on future loads of Study Designer. (OC-11806)
  • The Go button in Study Designer will no longer display environments the user does not have access to. (OC-12105)
  • Updated the examples provided in the Study Designer Table Design interface to aid in custom column configuration. (OC-11620)
  • Fixed an issue with when copying Participate forms to Common Events in Study Designer. (OC-11991)
  • Updated the Form Template in Study Designer to support new Stack 11 features. (OC-12113)

Runtime

  • Data Managers can now edit system-generated Participant IDs without changing the study settings. (OC-9676)
  • Removed mouse-over context menus for Events and Forms from the Participant Matrix to improve usability and enable usage on touch-screen displays. (OC-11512, OC-11795)
  • Made custom columns in the Participant Matrix sortable. (OC-11482)
  • Made custom columns in the Queries table sortable. (OC-11556)
  • Item brief descriptions will now be displayed as column headers in CRF Summary tables for Common Events on the Participant Details page. (OC-8892)
  • Updated the database underlying the Participant Matrix and Queries table to better support custom columns. (OC-11725)
  • Improved the way the Add New Participant dialog behaves to reduce confusion when creating Participant IDs. (OC-11588)
  • Removing a Participant from the study now automatically closes all queries associated with that Participant. (OC-9585)
  • Migrating a Form to a version that does not include an item now automatically closes all queries associated with that item. (OC-11580)
  • Fixed an issue that could cause the View within Record display for viewing a query in context within a Form to appear empty. (OC-11601)
  • Fixed an issue where removing a record associated with a Participant could sometimes interfere with the ability to later sign off on that Participant. (OC-11450)
  • Added Participant ID to the confirmation message when reassigning Participants. (OC-9471)
  • Users should see performance improvements of up to 60% on the View / Enter Data page for an Event. (OC-11751)
  • Removed irrelevant action options for removed Forms from the View / Enter Data page for an Event. (OC-9647)
  • Fixed an error that could occur when trying to open a Form in a Study that is in Design status. (OC-11882)
  • Added the Item Label and Brief Description to query notifications. (OC-9605)
  • Updated the link included in query notification emails to appropriately filter the Query table after it is clicked. (OC-11250)
  • Removed the Add New button for removed Participants from the Common Events page, since removed Participants should not have new Common Events added. (OC-11308)
  • Fixed an issue that could make it impossible to edit items within a Dataset from the View Datasets menu. (OC-11678)
  • SPSS Data Extracts will now include variable labels. (OC-11447)
  • SAS extracts now include item descriptions. (OC-11748)
  • Fixed an issue that could cause the extract list to fail to include the correct Dataset Format for previously run extracts. (OC-11419)
  • Reordered the options to View and Create Datasets on the Tasks menu so that they are consistent for all users. (OC-11832)
  • Fixed issues related to errors arising from removing a Monitor’s Form-specific permissions while they are accessing the SDV page. (OC-11749, OC-12139)
  • Fixed an issue that could cause the Add New Visit Event button to disappear from the Participant Details page in cases where events included Forms that were restricted with Permission Tags. (OC-11536)
  • Removed the Add New button from the Participant Details page for Non-Repeating Common Events if there is already a Form present for that Event. (OC-11633)
  • Improved usability on the Participant Details page by updating hover text to be more accurate. (OC-11709)
  • Update the Participant Matrix to include the appropriate set of options for all Forms based on their statuses. (OC-9482)
  • Improved usability of the Bulk Actions Log page with updated help text. (OC-12073)
  • Removed the option to download Rule files from studies with no available Rules to download. (OC-11135)
  • Fixed an issue with multiple studies that contain Events of the name that could interfere with Rules referencing one of those Events. (OC-12099)
  • When importing data into complete Forms, users can now supply a Reason For Change for all items in the Form automatically by including it in their import file. (OC-10918)
  • Added informative error messages when imports are attempted with files that are invalid due to missing or invalid Study IDs. (OC-11453)
  • It is now possible to import data for a signed Participant, consistent with how data can be entered for such Participants manually via the Form UI. (OC-11596, OC-11632)
  • Fixed an issue where importing data to a field that does not support the contained data type within an Unscheduled Event could set the Event’s status to Scheduled and the form’s status to Initial Data Entry. (OC-11814)
  • Fixed an issue where creating Non-Repeating Common Events via an XML import could result in multiple instances of the Event being created. (OC-11805)
  • Updated the import template to support new Stack 11 features. (OC-11747)

Forms

  • Significant performance improvements (up to 80% or more) in forms using cross-form logic can now be achieved by configuring the Form to have access to only those Events relevant to the logic on the Form. Previously the Form had access to all Events whether or not they included relevant items, which could impact performance. (OC-10066)
  • Activity by the user within a Form will now correctly reset the timer for an automatic timeout, preventing the user from being logged out while working on the form. 1 hour of inactivity will cause them to be logged out. (OC-10099)
  • Added ability for Data Managers to define item-specific Required Messages on forms. (OC-11917)
  • Improved help for date calculations using Event Start Date to provide best practice that will prevent calculation errors for users of Internet Explorer. (OC-11659)
  • Improved line-break behavior of radio button and checkbox items in Forms. (OC-11575)
  • Fixed an issue related to Form page navigation in some Forms with Repeating Groups. (OC-12145)
  • Fixed an issue that could prevent the Assign To list in the Query widget from populating. (OC-11723)
  • When printing forms with Show History enabled, they will now show history for all items that have any history (current or previous non-null value, queries, etc.) even if the items are currently hidden on the Form. (OC-11673)
  • Fixed an issue in which printed Forms were breaking text in the middle of an item or history section. They now format text more appropriately, breaking pages between items or history sections. (OC-11750)
  • Resolved an issue that could result in calculated fields not being correctly represented in the Query Widget History section before the form was reopened. (OC-11829)

Participate

  • Fixed some issues related to scrolling on Participate Forms. (OC-9901, OC-9902)
  • Added a Copy button to the Participant Details page where Participant access codes are generated to allow CRCs to more easily help Participants start data entry for in-clinic usage. (OC-11480)
  • Updated Participate access codes to avoid including characters that can be easily confused for each other so that Participants are less likely to mistype their access code. (OC-11627)
  • Fixed an issue that could result in the Participate Invite table on the Participant Details page not being displayed shortly after the activation of the Participate module. (OC-11982)

REST API

  • Updated the GET Participants API to allow for data retrieval from locked studies. (OC-11590)
  • Fixed an issue in which the GET Participants API could return data with incorrect timestamps. (OC-11757)
  • Implemented significant performance improvements in the API call to get Participant access codes in bulk. (OC-11788)
  • Added default pagination to the API that provides Participant access codes for improved performance. (OC-11745)
  • Fixed an issue that could cause some API calls to fail. (OC-11767)

General

  • Improved the behavior that occurs when navigating away from the Profile page to make it more intuitive. (OC-10042)
  • Proactively fixed potential security vulnerabilities.
  • Updated the Help system to support more targeted display of content specific to the user’s context rather than one set of content for all users, improving the value of this resource. (OC-12015)

 

 

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