1 OpenClinica 4 - Release Notes 2020

 

OpenClinica 4 Stack 11.7 (Release Date - 10 July, 2020)

OpenClinica 4 Stack 11.7 contains targeted fixes to OpenClinica. View the entire Stack 11.7 Changelog here (login required). 

For an overview of the update, view the Stack 11.7 Release Announcement here.

Highlights include: 

New: 

Study Build System

  • Added Content Library to Form Designer. This allows administrators to create, edit, and manage a shared library of items, item groups, and entire forms across all of their studies. Other users within their customer domain can drag library content into their forms during form editing.

Changes & Fixes: 

Study Build System 

  • Added Form and Event OIDs to the Form/Event cards in Study Designer prior to publication to support the creation of rules and cross-form logic. (OC-12557)
  • Added Select All/Unselect All options to Multi-Selection interface in Study Designer. (OC-9802)
  • Updated the downloaded version of the Study Designer Activity Log to include publish activity. (OC-12278)
  • Fixed issues with uploading large media files in Study Designer. Study Designer now supports combined file sizes of up to 50 MB per form version or draft. (OC-12280OC-12285)
  • Copying a form from a Common Event to a Visit-based Event with a table configuration will no longer copy the table configuration (which could lead to subsequent unexpected behavior). (OC-12284)
  • Updated Activity Log entry when a user first access a Study in in Study Designer to more clearly describe the activity. (OC-12302)
  • Added support to drag-and-drop multiple items at once in Form Designer. (OC-12899)
  • Added a bulk delete action to Form Designer. (OC-12581)
  • Added a bulk duplicate action to Form Designer. (OC-12582)
  • Increased the size of Form Designer and Form Designer Preview windows to provide more working space. (OC-12772, OC-12773)
  • Fixed an issue in Form Designer Preview that showed labels in all uppercase letters for Grid forms. (OC-12580)
  • Updated item appearance configuration to separate primary appearance and column width for Grid forms. (OC-12722)
  • Added Parent Group Width to item appearance configuration for Grid forms to provide context for the item width configuration. (OC-12840)
  • Updated group appearance configuration to match the updated item appearance configuration. (OC-12841)
  • Updated error message when an improperly designed form with multiple languages is opened so that the user will know how to address the issue. Multiple language forms can be loaded in Form Designer as long as all user-facing content columns specify which language they are used for. (OC-11938)
  • Added the ability to define items with external file response lists (i.e., select_one_from_file type items) in Form Designer and load forms containing these items. (OC-12064)
  • Fixed issues occurring with autopopulation of Item Group when using nested Layout Groups in Form Designer. (OC-12190, OC-12277)
  • Fixed issues associated with opening or editing forms with UTF-8 characters in Form Designer. (OC-12314, OC-12378)
  • Fixed an issue that could occur in Form Designer when using Firefox that caused some changes to item settings to fail to save. (OC-12316)
  • Fixed an issue where Form Designer was inappropriately allowing the user to select "contactdata" or "clinicaldata" for "Use External Value" for item types that did not support these configurations. (OC-12358)
  • Fixed an issue where "clinicaldata" items were incorrectly displaying an error message for not having an Item Group defined. (OC-12598)
  • Removed non-applicable Required configuration option from Note type items. (OC-12721)
  • Removed non-applicable Accepted Files configuration option from File type items. (OC-13035)
  • Improved Form Designer usability by having the interface shift focus to the response choice's label field after adding a new response choice. (OC-12383)
  • Form Designer will now correctly flag a draft as having unsaved changes if the response choice values have been changed for Select One or Select Multiple type items. (OC-12387)
  • Updated spreadsheet downloads for forms edited in Form Designer to include all columns found in the Form Template. (OC-12412

 

OpenClinica 4 Stack 11.5.1 (Release Date - 23 June, 2020)

OpenClinica 4 Stack 11.5.1 contains targeted fixes to OpenClinica. View the entire Stack 11.5.1 Changelog here (login required). 

Highlights include: 

Changes & Fixes: 

  • Updated system user handling to support future development efforts. (OC-13000)


OpenClinica 4 Stack 11.5 
(Release Date - 12 March, 2020)

OpenClinica 4 Stack 11.5 contains targeted fixes to OpenClinica. View the entire Stack 11.5 changelog here (login required). 

For an overview of the update, view the Stack 11.5 Release Announcement here.

Highlights include:

New: 

Runtime

  • Added columns for Form and Form Version to SAS Extracts. (OC-9723)

Participate

  • Added a QR code version of the Participant Access Code to the Participant Details page to make in-clinic Participate usage easier without requiring the copying or typing of the Participate URL or the Access Code. (OC-12000)

Changes & Fixes: 

Study Build System 

  • Fixed issues where users with specific characters in their usernames were unable to access Form Designer as expected. (OC-12377, OC-12373)
  • Fixed an issue that caused Form Designer to fail to load as expected in customer subdomains containing specific characters. (OC-12375)
  • Fixed an issue that could cause newly created users' access to Form Designer to be delayed. (OC-12401)
  • Fixed an issue that could cause Form Designer to display an error page when users tried to access it. (OC-12374)
  • Fixed an issue that could cause publishing a Study to fail if it contained a form in a Visit Event that had been copied from a Common Event. (OC-12231)
  • Updated Study publish error messaging to be inclusive of forms created in Form Designer and via spreadsheet upload. (OC-12129)
  • Added validation to prevent the addition of a form to a Study if it contains items with names longer than 40 characters. (OC-12357)
  • Added validation to ensure that forms added to a Study do not contain items of a type other than calculate with the Use External Value field set to "clinicaldata", as including such items can cause errors when entering data. (OC-12353)
  • Added validation to prevent the addition of a form to a Study if it specifies conditional logic in the Read Only field for any items. The system will now correctly reflect that conditionally read-only fields are not currently supported. (OC-12324)
  • Added validation to prevent the addition of a form to a Study if it includes items with the same name as an item group used in a repeating group, which can cause issues with data entry. (OC-12170)

Runtime 

  • Fixed an issue where forms in Locked sites were able to be opened in Review-only mode instead of Read-only mode. (OC-12275)
  • Fixed an issue that could allow Study-level users to add data to Locked sites. (OC-12332)
  • Fixed an issue where some users where able to "Delete" Locked Event CRFs in certain cases. (OC-12334)
  • Fixed an issue that could cause a Signed Event to become un-signed when a form within it was opened in Edit mode and then closed with no changes. Only editing data or marking a new form Complete will un-sign the event. (OC-12265)
  • Fixed an issue with SAS Extracts where an error in output files required manual editing to allow the files to be loaded into SAS. (OC-11593)
  • The Queries page now correctly displays status values associated with Event CRFs, rather than with Participants. (OC-12159)
  • Fixed an issue that could cause CSV exports of the Queries page to include the wrong Item Names. (OC-11703)
  • Fixed an issue that prevented the printing of PDF Casebooks for Locked Studies. (OC-12281)
  • Fixed an issue that could cause Site User attempts to print PDF Casebooks to fail. (OC-12341)
  • Fixed a few issues with PDF Casebook printing that could occur if the associated Participant ID contains an apostrophe. (OC-12307, OC-12336)
  • Updated PDF Casebooks to mask all contact information fields even for CRC and Investigator users. (OC-12268)
  • Fixed an issue where the contents of adjacent long text fields in printed PDF Casebooks would overlap. (OC-12196)
  • Improved performance of PDF Casebook printing when the forms contain video, audio, or other non-printable files. (OC-12110)
  • Added additional logging on notification action rules to aid in troubleshooting. (OC-12338)

Forms 

  • Fixed an issue where date fields defined as partial dates (e.g. year only or month-year only) were displaying as full dates when displayed as Read-only. (OC-12266)
  • Fixed an issue where printed forms were duplicating the text of hyperlinks in text fields. (OC-12208)

Participate 

  • Fixed an issue with Participate that could cause an error page to display when attempting to log back in after a session timeout. (OC-12026)
  • Fixed an issue that could cause the generation of a new Participate access code to fail to be recorded in the audit log. (OC-12216)
  • Confirmation dialog was added to the "Let's Move On" option in Participate, to decrease the chance that participants will move on from an event before they are ready. (OC-12388)
  • Text was updated on the Participate dashboard, and the progress bar was removed to improve usability. (OC-12365)

REST API 

  • Removed a potential block on using the Participant API. (OC-12367)

General 

  • The dialog to update a user password through the Profile page will now display the requirements new passwords must meet if an invalid new password is entered. (OC-10230)
  • Improved compatibility of some OpenClinica modules with upcoming security features for the Chrome browser. (OC-12214 

 

OpenClinica 4 Stack 11.4 (Release Date - 18 February, 2020)

OpenClinica 4 Stack 11.4 contains targeted fixes to OpenClinica. View the entire Stack 11.4 changelog here (login required). 

Highlights include: 

New: 

  • Added the ability to create new forms and edit existing forms using a drag-and-drop Form Designer. Allows setting a form style and version; adding, editing, deleting, or grouping questions; changing the order of questions; previewing forms in real time; saving the form as a draft; and adding the draft form to the study. It allows adding questions to a library and copying questions from the library as needed. Form Designer can be used instead of or in conjunction with uploading Form Definition spreadsheets.

Changes & Fixes: 

  • Improved stability of uploading large media file attachments with Form spreadsheets. (OC-12151)
  • Updated the Table Design search interface to improve item search usability. (OC-11612)
  • Fixed issue where Table Design interface might not load for some studies. (OC-12230)
  • Added Study Publish activity to Study Designer Activity Log. (OC-10889)

Note: Stack 11.3 was reserved and was not deployed to Production environments.


  

OpenClinica 4 Stack 11.2 (Release Date - 2 February, 2020)

OpenClinica 4 Stack 11.2 contains targeted fixes to OpenClinica. View the entire Stack 11.2 changelog here (login required). 

Highlights include: 

Changes & Fixes: 

  • Fixed an issue where complete forms with cascading select items could prompt users to enter Reason for Change when the cascading select item values had not changed. (OC-12199)
  • Fixed an issue that could cause Grid forms within PDF Casebooks to have inconsistent formatting. (OC-12074)

 

 OpenClinica 4 Stack 11.1 (Release Date - 31 January, 2020)

OpenClinica 4 Stack 11.1 contains targeted fixes to OpenClinica. View the entire Stack 11.1 changelog here (login required). 

Highlights include: 

Changes & Fixes: 

  • Fixed an issue that could prevent site users from accessing forms they had privileges for based on Permission Tags. (OC-12203)

 

 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-11512OC-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-11749OC-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-11596OC-11632)
  • 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-9901OC-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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Functional approval by Malcolm Jackson (mjackson), Product Owner. Signed on 2020-07-10 7:37PM

Approved for publication by Jigyasa Gupta (jgupta), Software Test Engineer II. Signed on 2020-07-10 7:49PM

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