1 OpenClinica 4 - Release Notes 2018

OpenClinica 4 Stack 5.1 (Release Date - 5 July, 2018)

OpenClinica 4 Stack 5.1 contains a variety of minor enhancements and fixes to OpenClinica. View the entire Stack 5.1 changelog here (login required).

Highlights include: 

Changes & Fixes: 

  • Updated the General Information section of the Participant Details Page to remove the following fields - OID, Person ID, Secondary ID, Sex, Date of Birth, and Enrollment Date. 
  • Fixed an issue where opening a form using the View Query Within Record link from the Query Manager page was causing an error message to be displayed if the form being accessed was in a Locked Event. 
  • Fixed an issue where the timestamps shown in the History section of the on-form Query Widget were not displaying the correct date and time in some cases.

Removed:

  • Updated the Add Participant and Update Participant pages to remove all fields except Participant ID. The following Participant data fields have been removed - Person ID, Secondary ID, Sex, Date of Birth, and Enrollment Date. If this data is needed for a study, the appropriate fields should be added to a standard Visit-Based Event Form or Common Event Form.
  • Updated the Add Participant and Update Participant pages to remove the fields that allowed a user to schedule the new Participant's first Event. After the new Participant is created, the user can schedule an Event as needed from the Participant Matrix, Participant Details Page, or Schedule Event link.

 

OpenClinica 4 Stack 5 (Release Date - 28 June, 2018)

OpenClinica 4 Stack 5 contains a variety of enhancements and fixes to OpenClinica. View the entire Stack 5 changelog here (login required).

Highlights include:

New: 

Runtime

  • Concurrency Locking functionality has been added to prevent concurrent data entry into the same record by different users. When a user opens a form in edit mode or review-only mode (i.e., queries only mode), they will acquire a lock on it. Any other user attempting to open the locked form will automatically open it in read-only mode. Additionally, locked forms cannot be deleted, removed, or reassigned by other users. If a user is prevented from performing an action due to another user having a lock on a form, a message will tell the user who currently has a lock on the form. The user's lock on the form will be released when the user closes the form via the Close or Complete buttons or when the user's session expires due to inactivity.
  • Updated the Participant Details page to make the page view settings persist during a user's session. Filtering, sorting, etc., of the Common Event tables will persist when the user navigates back to this page. Page view Persistence is Participant-specific. The page view can be reset at any time by clicking the "Customer View On" button. It will reset automatically when the user logs out or changes to a different study. 
  • Added ability for all user roles (except Monitors) to remove and restore events and forms.
  • Improved external API coverage and added a user access token system for using the APIs.

Study Build System

  • Added a feature to download the Excel form definition for an archived form version in Study Designer. This is accessible from the Archives.

Forms

  • When a form is being printed using the on-form Print button, the user is now prompted to choose whether to include item history. If history is not included, the printed version of the form will contain only the data items on the form. If history is included, the print form will include the data items on the form and the history of each item (for example: value changes, queries, and reasons for change).

General

  • A link to the Privacy Policy has been added to the user menu for all users across Runtime and the Study Build System.

Changes & Fixes: 

Runtime

  • The terms 'Subject' and 'Study Subject' have been replaced with 'Participant' throughout OpenClinica. The Subject Matrix is now the Participant Matrix, Add Subject is now Add Participant, etc.
  • Fixed an issue where the SDV interface was not displaying the correct form version information after a form was migrated to a different version.
  • Fixed an issue where a user attempting to navigate from Runtime to the My Studies, My Profile, or Administration pages would sometimes be bounced back to Runtime.
  • Fixed an issue where some users were redirected to their home screen when they attempted to edit their information on the My Profile page.
  • Fixed an issue where Data Managers would sometimes get redirected to the Change Study page after leaving the My Profile page.
  • Fixed an issue that was preventing a success email from being sent to a user when their extract finished generating.
  • Fixed an issue where Query notification emails showed the incorrect "updated by" user.
  • Fixed an issue that was causing repeating events to be displayed in the Participant Matrix with their creation date rather than their Start Date.
  • Fixed an issue that was not allowing forms in a Stopped event to be edited. If a form in a stopped event is edited now, the event is automatically changed back to Data Entry Started status.
  • Fixed an issue where updating an event's status from Stopped to Data Entry Started was sometimes changing the status of forms in the event from Data Entry Started to Complete.
  • Fixed an issue where form data could be imported for multiple versions for the same form in the same event for the same Participant.
  • Fixed an issue where the ending form status defined in the import data file was not being respected during the import process.
  • Fixed an issue that allowed non-Data Managers to access the locking interface for Common events.
  • Fixed an issue where a user was able to delete a form in a locked event.
  • Fixed an issue that caused an Edit button to be displayed for "Not Started" forms within locked events.
  • Fixed an issue that caused Common Event forms defined as hidden to be hidden from study-level users. These forms are now correctly hidden from only site-level users.
  • Fixed an issue where an existing form in a Common Event remained editable for a Participant even after the form was archived.
  • Fixed an issue where an existing form in a Common Event remained editable for a Participant even after the Participant was removed.
  • Fixed the label of Site ID in several pages where it was mis-labeled.
  • Updated the icon key to be consistent for all user roles and to include missing actions/status.
  • Updated the icon key and Participant Matrix/Participant Detail page to differentiate between the icons for Signed (status) and Sign (action).

Study Build System

  • Fixed an issue where publishing a large study would fail after 5 minutes. The publish timeout is now 1 hour to allow for very large studies to be published.
  • Fixed an issue where publishing a study fails when certain forms have been archived.
  • Fixed an issue where form upload would fail if there was already another version of the form and the version names of the forms were very similar (for example, the same except for non-alphanumeric characters).
  • Added validation to prevent uploading/publishing forms that exceed the system maximum length of a code list of 4,000 characters. If a single form version exceeds this limit an error message will be displayed at form upload time. If the limit is not exceeded by a single version of a form but is exceeded collectively by the combination of all versions of a form, an error message will be displayed at study publish time.
  • Fixed an issue where user logins were sometimes not being recorded consistently.
  • Fixed an issue where updating a user's role or type was not updating the "Updated" column in the User tables on the Share Study and Administration pages.
  • Fixed an issue where a user logging into the system was incorrectly updating the "Updated" column in the User tables on the Share Study and Administration pages.
  • Fixed an issue where inviting an existing user to a new study would change the user's status to "Invited".
  • Fixed an issue where in certain circumstances a user could log into a study they had recently been removed from.
  • Fixed an issue where forms would sometimes not be able to be reordered in Study Designer.
  • Updated the Form Template in Study Designer to reflect functionality changes in this release.

Forms

  • External data read capability has been expanded to allow the current form user's username and user role to be loaded into a form. This can then be used in logic on the form (for example, to make a note item visible to only users in a specific role).
  • External data read capability has been enhanced to retrieve external data when a form is opened in read-only or review-only modes. If the external data is displayed on the form (such as in an item label), it will now be displayed in those modes. Note that calculations will only be evaluated and displayed/submitted for forms opened in edit mode.
  • The on-form Query Widget has been updated to include the full timestamp of each item in the History section (instead of just a relative timestamp).
  • Fixed layout issues that caused incorrect "Required" error message placement for certain item type/appearance type configurations.
  • Fixed an issue where forms were not displaying correctly on smaller screens (such as on tablets or phones).

 

OpenClinica 4 Stack 4.1 (Release Date - 9 May, 2018)

OpenClinica 4 Stack 4.1 contains a variety of minor enhancements and fixes to OpenClinica. View the entire Stack 4.1 changelog here (login required).

Highlights include: 

New: 

  • The on-form Print icon has been restored. Existing forms and blank forms can be printed.

Changes & Fixes: 

  • Improved study publish performance. Publishing a study typically takes less than half as long as it did before this release.
  • Improved performance of Study Designer as additional forms are added to a study.
  • When an item of type "file" is added to a form, it will automatically accept files of any type without requiring additional configurations.
  • Updated mail server configuration to reduce the likelihood that user invitation emails will be flagged as spam.
  • Fixed an issue where the "clear" button to remove files that were uploaded to a form was not removing the uploaded files as expected.
  • Fixed issues where manually typed or pasted dates that were in the wrong format were not rejected as expected.
  • Fixed form layout/spacing issues with the Query icon and multi-line label text.

 

OpenClinica 4 Stack 4 (Release Date - 17 April, 2018)

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

Highlights include: 

New: 

  • Added support for non-visit-based events (known as "Common Events"). Repeating Common Events can be used to achieve repeating form functionality for use cases such as Adverse Events or Concomitant Medications. Non-repeating Common Events can be used for single-entry forms such as Early Termination.
  • Redesigned Subject Details page to support both visit-based events and common events and make the UI more user-friendly. Each Common Event is displayed in a separate collapsible section. Common Events can be configured to display form data as part of the table view on the Subject Details page. Common Events tables have new sorting, filtering, and pagination functionality. 
  • Added customer-wide People table to the Administration page. This includes a Deactivate option to remove user access at the customer level. (Note that user access can also still be removed per study.)
  • Added new file types for file upload items on forms. The following items are now supported (in addition to image): audio, video, and file (for generic files).
  • Three drawing items are now supported - draw (for drawing on blank canvas in multiple colors), annotate (for uploading an image and then drawing on it in multiple colors), and signature (for collecting a black and white signature). Each of these are saved as image files.

Changes & Fixes: 

  • On the Subject Matrix, each Subject ID is a link to go to the Subject Details page for that subject. This is helpful if the Subject Matrix is very wide.
  • Improved cross-form logic performance by making only subject clinical data accessible (not study metadata).
  • Uploaded files and drawings can now be downloaded directly from a form. The UI for uploading/removing files has been improved to prevent accidental file removal.
  • When inviting users to a study, you can search for existing users by name, username, or email address.
  • Updated the Share Page People table in Study Build System to have more user-friendly pagination and to make most columns sortable. Date columns now show both date and time. User Status is now included in the table.
  • When uploading a form, style "no-text-transform" is automatically applied to the form so that it doesn't need to be specified manually. This ensures that forms display label text case-sensitively.
  • When uploading a form, appearance "no-collapse" is automatically applied to each group so that it doesn't need to be specified manually. This ensures that the form user does not accidentally collapse a group and hide data unintentionally.
  • Improved performance and functionality support for Internet Explorer and Edge browsers.

Removed: 

  • Removed Print icon from on-form view.

 

OpenClinica 4 Stack 3 (Release Date - 15 February, 2018)

OpenClinica 4 Stack 3 contains a variety of enhancements and fixes to OpenClinica. View the entire Stack 3 changelog here (login required).

Highlights include: 

New: 

  • Added support for Cross-Form logic. External Values can be pulled into a form for use in calculations, constraints, hide/show, conditional required, and display piping.
  • User invitations can be resent from the Study Build System.
  • Reason for Change entries can be viewed from the Query Manager.

Changes & Fixes: 

  • Single Sign-on enhancements
  • Improved appearance of embedded documentation.

 


 

 

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Functional approval by Paul Bowen (pbowen), Product Owner. Signed on 2018-07-05 6:02PM

Approved for publication by Jim Bonica (jamesbonica). Signed on 2018-07-05 6:03PM

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