OpenClinica 4 Stack 7 (Release Date – 31 January, 2019)
OpenClinica 4 Stack 7 contains a variety of enhancements and fixes to OpenClinica. View the entire Stack 7 changelog here (login required).
- Added Participate module to allow ePRO data to be captured as part of a study. Participate is an optional module that can be requested for a study via the new Modules page.
- Once it is enabled, individual forms can be marked as Participate forms in Study Designer. These forms can then be previewed as Participate forms to see how they will look to participants. Any form in a visit-based event can be marked as a Participate form.
- Participants’ user accounts for Participate can be created with or without capturing any PII. When a participant user account is created with PII including email address then an invitation email can optionally be sent to the participant to notify them of how to access the study. Only users in site-level roles based on Clinical Research Coordinator (CRC) or Investigator can enter, view, or edit the participant PII needed to invite participants to the study. Any data captured directly by a participant via Participate is audited and attributed to the participant’s account. Data can also be entered to Participate forms by users logged in as study-level or site-level user roles with data entry permission. In that case, the data entry will be attributed to the user who entered it.
- Participants can access the Participate application either via the direct access link sent in the invitation email sent to them when they are invited to the study or by going to the study’s Participate URL and manually entering the access code included in the email. Once authenticated, the Participant will see the forms that are available for them to enter data in. A Participate form becomes available to the participant when the event it is in is Scheduled. It remains available to enter or edit as long as the event has Scheduled or Data Entry Started status and the form has Not Started or Data Entry Started status. Once a participant has finished entering data on their forms, their dashboard will give them the option of moving on and this will mark the Participate forms as complete. If the participant has no forms available to enter, an appropriate message will be shown to the participant on their dashboard.
- Participants will be able to enter form data using a computer or mobile device. Data will be auto-saved as it is entered to protect against data loss. Any edit checks programmed into the form will be strictly enforced when a Participant is entering data. Participants will not be able to finish data entry while there are any errors on the form. Participants will not have access to view or enter queries or view item history while on the form or from the Participate dashboard.
Study Build System
- Added Modules page to allow users to request access to the following optional modules for a study: Participate, Randomize, and Insight.
- Added support for external CSV code lists for single-select items. These external lists can be used with items of type select_one_from_file. They allow code lists to be used that exceed the system limitations for lists defined directly within the form’s Excel file.
Changes & Fixes:
Study Build System
- Improved performance of loading Study Manager for the first time after login.
- Fixed an issue where entering a custom role description longer than 255 characters caused an internal server error message to be displayed. The description field no longer accepts more than 255 characters.
- Fixed an issue where publishing a study would fail when a user in that study had a name that contained an apostrophe.
- Fixed an issue where users would not be automatically logged out of Study Manager in certain cases where they closed their computer while still logged in.
- Fixed an issue where certain users were unable to be edited or removed in cases where a study had many users.
- Fixed an issue where user logout events were not being included in the User Audit Log.
- Updated permissions to disallow Admin users who are not Data Managers in a study from adding or editing sites in that study.
- Fixed an issue where Data Managers for a study who changed their role to something else and then back to Data Manager were unable to access Study Designer for that study.
- Fixed an issue where certain Data Managers were unable to access Study Designer.
- Fixed an issue where uploading forms with attached files totaling above 10 MB was causing the upload to fail and Study Designer to become unstable until the user left and came back in.
- Updated Study Designer to support previewing forms with external files including embedded video and audio files and external CSV code lists. Image files were already supported.
- Fixed an issue in Study Designer where the study publish status message in the title bar was sometimes showing the status of a different study.
- Updated Study Designer to prevent uploaded forms from using the same name for an Item and the Group it is in. Forms in this state could have had been unable to save data to the Item in this case.
- Updated Study Designer to prevent Items of type Calculate from being defined as Read-Only or have Constraint or Relevant logic. A form with an Item in this state could have shown unexpected error message on the Group containing the Item in this case.
- Fixed an issue in Study Designer where typing the Home key would cause an Application Offline message to appear and Study Designer to become unstable until the user left and came back in.
- Updated Study Designer to allow the Multi-Selection feature to be used to add or remove Permission Tags to forms.
- Updated form cards to have a scroll bar on the versions list in case a form has many versions available.
- Fixed an issue that was preventing the common event form Fields to Display list from scrolling in certain cases.
- Fixed an issue where Study Designer form tiles within an event would sometimes scroll unexpectedly.
- Updated audit text for form SDV setting changes to better reflect that the change only applied to the form within that specific event.
- Fixed an issue where the title bar would sometimes not show the study status when the user navigated directly from Study Designer to the Settings or User Roles pages.
- Updated Study Designer Multi-Selection button to be able to be toggled off by clicking anywhere within the button rather than only on the small X.
- Removed extraneous links for Remove from Form and Update Profile that appeared if you clicked on users on a form card.
- Updated the Form Template in Study Designer to reflect functionality changes in this release and clarify instructions.
- Fixed an issue where the help text in the title bar would sometimes overlap the study status text.
- Improved performance of loading the Participant Details page for Participants with many forms.
- Fixed an issue where the Participant Details page would display a Visits section in studies with only common events in certain cases where events had been archived from the study definition.
- Fixed an issue where changing the order of forms within an event was not being reflected in Runtime once the study was published. Note that on the Participant Details page, forms are still sorted first with forms that have not been started and then with forms that have been started. With this update, the list of not started forms will match the order the forms had in Study Designer at the time of publish.
- Updated the default length of most tables to display 50 records upon load.
- Updated so that a Signed Participant is automatically reverted to Available if a new event is scheduled for them.
- Updated so that a Signed Participant is automatically reverted to Available if a new form is opened and marked as complete without entering any data into it.
- Updated so that a Signed Event is automatically reverted to Completed if a new form is opened and marked as complete without entering any data into it.
- Fixed an issue where the Add Participant link didn’t immediately respond to the new study when changing between a study that had exceeded the Participant Enrollment Limit and one that had not exceeded the limit or had no limit. Previously, the link wasn’t responsive until the user navigated the new study further after switching studies.
- Fixed an issue with the SDV Status filter not working correctly in the SDV table.
- Fixed an issue where using the Query Manager to open an event-level query was opening the wrong record in certain cases.
- Fixed an issue where the View Site and Edit Site pages were causing errors in certain cases.
- Fixed an issue where form Created By was not being updated in internal tables when data was first entered into a form in certain cases. This did not impact the audit trail.
- Fixed an issue where event Date Completed was not being updated in internal tables when an event was completed in certain cases. This did not impact the audit trail.
- Fixed an issue where forms in Skipped and Stopped events were able to be edited in some cases. These forms are now only editable when the event is moved out of Skipped or Stopped status.
- Fixed an issue where a participant’s status was not updated to Removed when the Participant was removed.
- Fixed an issue where restoring a Removed site-level Participant was causing an error.
- Fixed an issue where certain site users were unable to view their Profile page in some cases.
- Fixed an issue where the API to retrieve Participant IDs would permit users authenticated at the site level to receive IDs for Participants at other sites. No clinical data was accessible outside of the user’s site.
- Fixed an issue where an import file with duplicate common event forms was not being rejected as expected.
- Fixed an issue where an import file with invalid common event form data was causing the common event repeat key to increment even though no new record was created by the import.
- Fixed an issue where an unexpected error message was shown if an import data file was missing event repeat key. For common events, a user-friendly error message is now shown in this case. For visit-based events, the import will proceed with the empty repeat key treated as the value 1.
- Updated the buttons in the navigation bar to be clickable within the entire button rather than just on the button text.
- Improved form loading performance for forms that do not read in cross-form data.
- Fixed an issue where the first form started in an event was not able to read in event-level data (such as Start Date or Repeat Key) using the cross-form data feature.
- Fixed an issue where repeating groups with relevant expressions were being hidden when the first repeat of the group was completely blank but other repeats contained data. In this case, the data in the other repeats was hidden from view while the group was irrelevant, but the data was not cleared.
- Fixed an issue where certain forms with calculations within repeating groups were opening with unexpected error messages.
- Fixed an issue where multiple page forms with nested groups with relevant expressions may not show the user the Next button when the form is first opened.
- Fixed an issue where calculated items in groups with relevant expressions may not be hidden when expected.
- Fixed an issue where calculated items with open queries that became irrelevant might not have their auto-closed query entries records. The queries were still being auto-closed in this case.
- Fixed an issue where entering an all-space value in a text item was appearing as a distinct change to spaces in the item history when viewed within the form session. Since an all-space value is considered as null, the history now treats this as a null value within the form session and after leaving and then returning to the form.
- Fixed an issue where multiline text items and select multiple items that were required were not showing the red asterisk as expected in certain cases.
- Fixed an issue where Likert items were not rendered as expected when code text was long for some options.
- Fixed an issue where opening a form directly to a specific query from the Query Manager was not showing the correct message if the item the query belonged to was currently hidden.
- Fixed an issue where using Query Manager to open a query on a form that contained no other data was causing an error.
- Fixed an issue that prevented large (greater than 10 MB) files from being uploaded within forms. Files up to 95 MB are now accepted.
- Fixed an issue where annotation widgets were not rendering as expected in read-only and review-only modes.
- Fixed an issue where printing a form in Safari, Firefox, or Internet Explorer 11 was not producing the expected results in some cases.
- Fixed an issue with forms opened in Firefox where Queries could not be added to items in certain cases.
- Fixed an issue where certain forms were unable to be opened in Internet Explorer 11.
- Fixed an issue where an error would be triggered in Internet Explorer 11 when a form was opened in certain cases.
- Added configuration options to support defining site-specific randomization rules for sites in the Test study environment and then using the same configuration without changes if those same sites are added to the Production study environment.
- Updated authentication methods. The new model provides greater overall configuration options, including password expiration (which is set to 180 days). Due to the change in authentication model, existing users will be required to set a new password the first time they access the system after this version is released. A password reset email will be sent to the user on their first login attempt. Passwords are required to be at least 8 characters long and include 1 each from the following groups: lowercase letters, uppercase letters, digits, and special characters.
- Session inactivity timeout has been updated to 1 hour for all components of OpenClinica.
- Added support for more data centers so that customers have more options for where their data is stored.
- Added support for SSL connections to the Postgres database.