OpenClinica 4 Stack 13.2 (Release Date – 08 April 2021)

OpenClinica 4 Stack 13.2 contains targeted fixes to OpenClinica. View the entire Stack 13.2 changelog here (login required).

Highlights include:

Changes & Fixes:

  • Improved Study Runner performance. (OC-14637)
  • Improved performance of the Participant Matrix when Custom Columns are in use. (OC-12974)
  • Improved performance of the Participant Matrix for users with signing permission. (OC-14584)
  • Improved performance of the Participant Matrix when filtered to a single event. (OC-14548)
  • Fixed an issue with the Participant Matrix not loading correctly after cancelling an action.(OC-14510)
  • Fixed an issue with the Participant Matrix displaying started forms as Not Started. (OC-14604)
  • Fixed an issue with Custom Columns on the Participant Matrix not sorting null values consistently. (OC-14779)
  • Fixed an issue that could cause signing Participants to fail in some cases. (OC-14808)
  • Fixed an issue with study publishing failing if an event with an open Start Date or End Date Query is being archived. (OC-14582)
  • Fixed an issue with system-generated IDs not being created correctly in some cases. (OC-14549)
  • Fixed an issue with Rules not firing based on the current date as expected in some cases. (OC-14597)
  • Update Tabular import to allow mapping the Participant ID column to an item on the form. (OC-14111)
  • Fixed an issue with import that caused query updates to unsign Events. (OC-14622)
  • Fixed an issue with Form Last Updated Date not reflecting updates made via data import. (OC-14696)
  • Fixed an issue with importing data into select_one_from_file items. (OC-14786)
  • Fixed an issue with Events not being autocompleted when all Forms are marked Complete if the Event Definition contains archived forms. (OC-14661)
  • Fixed an issue with users sometimes being prompted to login again after successful login to Study Runner. (OC-14685)
  • Fixed an issue with inactivity timeout sometimes not working as expected when a computer is put into sleep mode during a session. (OC-14554)
  • Improved form loading performance. (OC-14721)
  • Fixed an issue with the View Queries Only link not working for Queries on items that do not have labels. (OC-14361)
  • Fixed an issue with Add Another form feature not working as expected. (OC-14567, OC-14608)
  • Fixed an issue with forms using pages theme that could result in non-relevant items containing data being displayed on every page. (OC-14682)
  • Fixed an issue with single select items on forms not printing correctly. (OC-14558)
  • Fixed an issue with blank forms not respecting page breaks when printed. (OC-14564)
  • Fixed an issue with Query Widget History not including labels for some selection items within the form editing session. (OC-14577)
  • Fixed an issue with Query Widget History not updating within the form editing session if one of the selections became filtered out by a choice filter. (OC-14686)
  • Fixed an issue with using View Query Within Record link for an image map item. (OC-13530)
  • Updated system modules to provide improved security.

OpenClinica 4 Stack 13.1.1 (Release Date – 23 March 2021)

OpenClinica 4 Stack 13.1.1 contains targeted fixes to OpenClinica. View the entire Stack 13.1.1 changelog here (login required).

Highlights include:

Changes & Fixes:

  • Improved performance for uploading a form version or adding a draft to a study. (OC-14645)
  • Fixed an issue that prevented forms from being added to a study if an item has a hint but no label. (OC-14614)
  • Fixed an issue with downloading a form version definition containing a large CSV file attachment that could result in the CSV file being corrupted. (OC-14490)
  • Fixed an issue with attempting to add a line break to an Event name that could cause Study Designer to hang. (OC-14442)
  • Fixed an issue that prevented users from using the Design button on a Form card after unarchiving the Form. (OC-14517)
  • Updated Study Designer to disallow Form names from starting with “F_” and Event names from starting with “SE_” to prevent subsequent publishing errors. (OC-14472)
  • Fixed an issue that caused some Study Designer icons to be displayed incorrectly on some Mac browsers. (OC-14397)
  • Fixed an issue for relevant or constraint logic defined using the logic builder Form Designer. (OC-14674)
  • Fixed an issue that could cause Form Designer to hang when opening an invalid multi-language form. (OC-14467)
  • Updated Form Designer to include hover text showing item type for existing items. (OC-13897)
  • Updated Form Designer to use different styling for item labels and the item label hint text displayed when a label is empty. (OC-14516)

OpenClinica 4 Stack 13.0.4 (Release Date – 6 March 2021)

OpenClinica 4 Stack 13.0.4 contains targeted fixes to OpenClinica. View the entire Stack 13.0.4 changelog here (login required).

Highlights include:

Changes & Fixes:

  • Fixed an issue where forms using the jr:choice-name() function would load with an error in some cases. (OC-14568)
  • Fixed an issue where repeating groups with relevant logic at the group level might cause the entire group to be hidden when the group is non-relevant and only instances after the first contain data. (OC-14575)
  • Fixed an issue where a triggered calculation using an item in a repeating group to trigger an item out of the repeating group could fail to work properly. (OC-14466)
  • Fixed an issue where Select One items in repeating groups might not be hidden when they become non-relevant. (OC-14563)
  • Fixed an issue where pages style forms could allow opening the Query Widget for non-relevant items without allowing it to be closed easily. (OC-14576)

OpenClinica 4 Stack 13.0.3 (Release Date – 24 February 2021)

OpenClinica 4 Stack 13.0.3 contains targeted fixes to OpenClinica. View the entire Stack 13.0.3 changelog here (login required).

Highlights include:

Changes & Fixes:

  • Fixed an issue where calculated items were not being cleared of data correctly when changes to other data in the form made them no longer relevant during form load. (OC-14542)

OpenClinica 4 Stack 13.0.2 (Release Date – 19 February 2021)

OpenClinica 4 Stack 13.0.2 contains targeted fixes, enhancements, and new features to OpenClinica. View the entire Stack 13.0.2 changelog here (login required).

Highlights include:

Changes & Fixes:

  • Details of archived forms are no longer included during study publish. (OC-14523)
  • Fixed an issue where some forms could fail to load correctly after publishing a study to restore archived events. (OC-14085)
  • Fixed an issue that could cause the reuse of form OIDs when form names were changed and new forms were added with similar names. (OC-14514)
  • Fixed an issue where archived forms were appearing in some Common Events on the Participant Details page. (OC-14519)
  • Fixed an issue that could cause new common event forms to not appear on the Participant Details page. (OC-14520)
  • Improved Participant Matrix performance. (OC-14518OC-14522, OC-14531)
  • Fixed an issue that was causing session time out to work incorrectly in some cases. (OC-14532)

OpenClinica 4 Stack 13 (Release Date – 13 February, 2021)

OpenClinica 4 Stack 13 contains targeted fixes, enhancements, and new features to OpenClinica. View the entire Stack 13 changelog here (login required).  For an overview of this update, view the Stack 13 Release Announcement here.

Highlights include:

New:

Study Build System

  • Added Study Viewer and Site Viewer user roles to all studies. These roles have permission to view events and forms, but not change data or manage queries. They also do not have permission to use data extracts. Custom roles can be created based on these roles as needed and permission tags can be assigned to them to manage form-specific access.
  • Added support for additional form logic options. All options support cross-form logic.

Defaults can now be defined to set item values at form creation (or when adding a new repeating group instance for items in repeating groups). They can be static values or calculated values (i.e., Dynamic Defaults). Items with defaults can be user-editable or read-only. Defaults can be used in conjunction with standard calculations or triggered calculations for an item (if needed).

Triggered calculations can now be defined to set items to a calculated value when a trigger item’s value changes. They do not have any effect except when the trigger item’s value changes. Items with triggered calculations can be user-editable or read-only. They can be used in conjunction with defaults (if needed).

With these new features, there are now three options for system-generated form item values. Standard calculations always keep the calculated value in sync with the other items on the form and they are re-evaluated every time the form is opened. Items using these must be read-only. Triggered calculations only update the calculated value when the trigger item’s value changes (regardless of any changes to items used in the calculation). Defaults update item values only when the form is first created and when a new repeating group instance is added.

Study Runner

  • XML imports now allow the import of Queries, Annotations, historical signature attestations, and the setting of SDV statuses. Using an XML import, you can now add Queries to items or update and close existing Queries in bulk, as well as add Annotations, set form SDV statuses to verified or not verified, and set the Signed status of Study Events to Signed while adding a signature attestation to the audit log. These can be done as part of an import of clinical data or imported independently without associated item data.
  • Tabular imports have been expanded with new features available in the mapping file. The SkipMatch feature of tabular imports has been expanded to allow choosing whether to skip the import of a row based on matching against a set of criteria or to update existing records when matches are found. Previously only new records could be added as part of a tabular import. To support matching and updating specific occurrences of repeating events, the start date and repeat key of repeating events can be included as optional columns in the tabular file. Using the start date, new instances of visit events can also now be scheduled as part of the tabular import. The post-import status of forms can now be configured. The Reason for Change to use if the import changes data on complete forms can also be configured. Finally, these imports can now be configured to ignore columns in the import file that are not explicitly mapped to items so that data files do not need to be modified to remove unmapped columns.
  • Added support for users to navigate directly from one repeating common event form to the next occurrence of that form. This allows data entry users who are adding new forms to choose to open the next form automatically without having to return to Study Runner and click the link for the form they want to open. This feature is only available during initial data entry for these forms, not for subsequent editing or viewing of the forms. It can be enabled per form using the Allow Add Another checkbox on the form card in Study Designer for each repeating common event form.

Changes & Fixes:

Study Build System

  • Added link to create a new study to the top of the My Studies page. (OC-12236)
  • Updated the My Studies page to have a more intuitive sorting. (OC-11220)
  • Fixed an issue that could result in duplicate participant IDs within a study. (OC-10552)
  • Removed typo in User Roles tab label. (OC-14205)
  • Fixed an issue where reusing site identifiers could cause errors when some users attempted to login. (OC-13321)
  • When publishing an overwritten form version, referenced files will now be cleared as expected. (OC-12972)
  • Fixed an issue where the wrong error message would be displayed for certain types of form issues when uploading a completed form definition spreadsheet. (OC-13997)
  • Added the ability to tag other Study Designer users in comments added to Study Designer cards. (OC-12931)
  • Fixed an issue where the popup to Discard a form draft in Study Designer could fail to render. (OC-13889)
  • Fixed an issue that could cause an extra character to be inserted into form names when using Study Designer. (OC-14166)
  • Added an error message to display when a form containing only calculate items is added to a study. (OC-12101)
  • Removed items that exist only in archived form versions from the configuration menus for adding custom columns to the Queries table and Participant Matrix. (OC-13726)
  • Improved form card performance in Study Designer. (OC-14190)
  • Added error checking on form upload to reflect that ‘data’ is a reserved word in form design and cannot be used as an item or item group name. (OC-14202, OC-14152)
  • Validating a form preview will now always correctly indicate when there is a non-strict error that needs to be resolved. (OC-14076)
  • Improved efficiency of form preview feature. (OC-13107)
  • Fixed an internal form definition structure issue. (OC-12853)
  • Updated form engine validator to enable support for new features. (OC-9114)
  • Updated Form Template to include Stack 13 features. (OC-13431)
  • Clarified label of Appearance in Form Designer. (OC-14203)
  • Fixed an issue that could cause Form Designer to unexpectedly change relevant logic. (OC-14370)
  • Updated Form Designer to allow items to have empty labels to use them as background calculations. (OC-14016OC-14018)
  • Fixed an issue where Form Designer would sometimes hang on load. (OC-13977)
  • Made conditional expressions required in form designer if conditional is selected. (OC-12458)
  • Added integer item appearance options to Form Designer. (OC-13776)
  • Added support for contact data in the Use External Value field in Form Designer. (OC-12287, OC-13750)
  • Fixed an issue where users whose usernames were email addresses could not access Form Designer. (OC-13642)
  • Added clarity to the error message displayed when Form Designer is unable to save. (OC-13701)
  • Fixed an issue where building a form with an external list item type in Form Designer could cause the form draft to become non-downloadable. (OC-13697)
  • Updated Form Designer to truncate the auto-populated values for item names at the maximum length of this field to avoid errors. (OC-13441)
  • Removed Beta designation from Form Designer UI. (OC-13133)
  • Added ability to preview forms with External List items in Form Designer. (OC-12627)
  • Added ability to preview forms with cross-form logic in Form Designer. (OC-13132)
  • Updated Form Designer Library List to include column for Version. (OC-13123)
  • Updated Form Designer Library so that uploaded content will now be saved as templates instead of blocks. (OC-13122)
  • Updated Form Designer Logic Item selectors to include items from the entire form rather than just items from earlier on the form. (OC-13309)
  • Updated Form Designer Logic Item selectors to include the item name as well as its label. (OC-13308)
  • Fixed an issue that could prevent further editing of a form in Form Designer after a large media file was attached to the form definition. (OC-13106)
  • Added the ability to cancel a drag and drop action by pressing ESC to Form Designer. (OC-13031)
  • Fixed an issue that could present invalid error messages when a newly created user used Form Designer for the first time. (OC-13004)
  • Fixed an issue that could cause problems with Form Designer’s handling of multi-language media columns. (OC-13108)

Study Runner

  • Improved performance in the Participant Matrix. (OC-13591OC-14406)
  • Fixed an issue that could cause a link to a completed form to work incorrectly when the Participant Matrix was filtered by an event. (OC-14407)
  • Fixed an issue where forms could be incorrectly displayed as editable in the Participant Matrix. (OC-13466)
  • Updated the Participant Matrix Event and Form links to be independent of user type and match the links on the Participant Details Page. (OC-13447)
  • Fixed an issue where options on the Participant Matrix were not being correctly adjusted based on user privileges. OC-13200)
  • Updated Status attribute to display on same line as workflow status on Participant Matrix. (OC-13199)
  • Updated labels for Participant Matrix form actions. (OC-14468)
  • Fixed an issue that could cause the signed status icon to fail to display on the Participant Matrix for repeating visit events after one occurrence of the event was removed. (OC-14167)
  • Updated which characters can be used in participant IDs. Greater than, less than, double quotes, single quotes, and ampersands can no longer be used in participant IDs. (OC-13732)
  • Changes to data related to a participant including item data, event status, and form status, will now update the Last Modified Date and Last Modified By fields of the associated participant. Queries and SDV status are excluded from this. (OC-12023OC-13184OC-13332OC-13553OC-13554OC-13555OC-13556OC-13558OC-13577OC-13578OC-13665)
  • Fixed some cases of an issue that could cause an error when multiple export jobs are scheduled concurrently. (OC-14481)
  • SAS extracts will now include site ID and form status. (OC-9109)
  • Fixed an issue that could cause CRFs not to appear in the header of Tab Delimited Text Extracts when used in multiple events. (OC-12585)
  • Significantly improved extract job performance. Time required for benchmark extracts reduced by several orders of magnitude. (OC-13851)
  • Updated the dataset creation feature to always list all versions for items in more than one form version. (OC-9830)
  • Fixed an issue where some extract formats would not include form version information. (OC-9777)
  • Data specialists and Investigators can now remove data sets they have created. (OC-14136)
  • Fixed an issue that could sometimes cause concurrent scheduled jobs to fail. (OC-13259)
  • Fixed an issue where applying a sort or filter on the table of job runs on the scheduled job detail page caused the page to fail to render correctly. (OC-12800, OC-12796)
  • Fixed an issue with migrating Event CRFs in bulk to different CRF versions. (OC-14133)
  • Fixed an issue that could prevent form version migration when the SDV status was set to Verified. (OC-13741)
  • Migrating a record to a different CRF version will no longer unsign the record. (OC-14277)
  • Fixed an issue in which migrating the version of a CRF could in some cases result in performance issues. (OC-14254)
  • Updated the Bulk Actions Log link label for Monitor users (OC-13780)
  • Improved accuracy of tabular import error messaging. (OC-14305)
  • Fixed an issue where importing tabular data into a form with an invalid or inactive form version OID could cause errors when attempting to enter data in the form manually or errors in the import. (OC-13630, OC-13595)
  • Fixed an issue where importing data into an event manually marked complete could cause the event status to change if unstarted forms were present in the event. (OC-14192)
  • Fixed an issue where tabular data could sometimes be imported for participants at unavailable sites. (OC-13346)
  • Fixed an issue where the ampersand character could cause XML imports to fail if included in item data. (OC-14160)
  • Added error message to correctly identify when a tabular import mapping file attempts to map data that are not present in the data file. (OC-14147)
  • When a time is not specified for Event Start Date, it should now correctly have no associated time, rather than showing a time of noon. (OC-13445)
  • Fixed an issue where a form’s concurrency lock could fail to be released if opened from certain pages. (OC-14068)
  • Query Notification Emails will now always link the user to the correct study. (OC-11033)
  • Fixed an issue where custom columns on the Queries table could cause a CSV download of the Queries table to be formatted incorrectly. (OC-14065)
  • Fixed an issue that could cause some Event Queries to be non-editable in certain browsers. (OC-13116)
  • Queries can now be assigned to invited users of the study prior to their initial login. (OC-13815)
  • Fixed an issue where pipe characters in item data was sometimes being interpreted inappropriately as a delimiter in tabular imports. (OC-14048)
  • Fixed an issue where the use of rules in a study could cause errors in tabular imports. (OC-14006)
  • Fixed an issue where a user account creation glitch could cause some pages to display errors. (OC-13931)
  • Fixed an issue where the user would sometimes encounter an error when clicking the link to view a participant from the Participant Matrix. (OC-13903)
  • Fixed an issue where the order of forms in Study Designer was not being respected on the Enter or Validate Data page in Study Runner. (OC-13871)
  • Fixed an issue that could cause changes made to site-level form configurations to fail to save. (OC-13700)
  • Fixed an issue that could cause inappropriate insufficient privilege errors when editing a form after updating settings related to site form versions. (OC-13463)
  • Fixed an issue that allowed participants with only removed or archived events to be signed. (OC-13621)
  • Fixed an issue where headers for Archived Common Events could be displayed for Participants who have no data in those events. (OC-13559)
  • Fixed an issue that could allow event statuses to be set to completed after required forms had been removed. (OC-13475)
  • Fixed an issue where the Restore Participants page was incorrectly showing the site value as the study value for participants assigned to a site. (OC-13439)
  • Updated the Sign Participants page to remove unused fields. (OC-13429)
  • Removing a required form from a Complete event will now update the event status out of Complete. (OC-13419)
  • Starting data entry on a new form in a Complete event will now update the event’s status out of Complete. (OC-13418)
  • Added the Audit Log Event Type Event CRF Cleared to replace the deprecated audit type Event CRF Deleted. (OC-13384)
  • Fixed an issue where the Sign Events page was missing event status icons. (OC-13292)
  • Updated to allow Data Specialists and Investigators to Sign Events and Participants using signature codes when SAML SSO is in use. (OC-14015, OC-14019)
  • Fixed an issue where archiving a form with a changed name and then creating a new form with the original name of the archived form could cause the View CRF page to display incorrectly. (OC-13238)
  • Fixed an issue where the SDV Detailed View was missing items from older version of forms. (OC-13166)
  • Imported data will now correctly set SDV status to Unverified if data in verified forms change. (OC-13490)
  • Fixed an issue where the SDV Item-level Details table would not handle commas correctly, causing some data to be displayed inappropriately in the table. All delimiters will now be processed correctly by this table. (OC-14082, OC-14092)
  • Fixed an issue where the SDV table would not correctly show all instances of a repeating event when some contained only a single item with data. (OC-13842)
  • Updated “Clear Event CRF” (formerly delete) confirmation page. (OC-12832)
  • Updated the Participants Details page to hide the header for an event if all forms within the event are hidden. (OC-12131)
  • Fixed issue that could cause Event Action Rules to fail. (OC-13906)
  • Performance improvements for Rules. (OC-14151)
  • Code maintenance improvements in Study Runner. (OC-14102OC-13268)

Forms

  • Field histories viewed on a form now display the value and the label associated with each change. (OC-7954, OC-14049)
  • View Query Only form view will no longer display with a collapsible group label. (OC-9021)
  • Added a message that will appear when viewing forms in Removed or Archived events, indicating the form is in such an event. (OC-14059OC-13393)
  • Fixed an issue where a Query could fail to auto-close correctly if the associated item was not appearing as relevant when the form was initially opened. (OC-13902)
  • Fixed an issue where changing data in a completed form and then closing it without providing the required Reason for Change would automatically log a Reason for Change instead of a Query. (OC-13804)
  • Updated the message indicating the maximum size for uploaded files to be more exact. (OC-13768)
  • Fixed an issue that could interfere with the successful running of cross-form logic. (OC-13744)
  • Fixed a layout issue that could arise in printed PDF casebooks in Firefox. (OC-13561)
  • Fixed an issue where when copying and pasting data of the wrong type into a field, no change in the data was saved in the form. (OC-13531)
  • Fixed an issue where no error message was being displayed when a form is opened with an external file that is missing. (OC-13479)
  • Fixed an issue where multiple consecutive analog scale items could cause the form to render incorrectly. (OC-13436)
  • Fixed an issue where form labels starting with a digit and period would be indented unexpectedly. (OC-13400)
  • Fixed an issue where image maps in printed PDF casebooks could sometimes display incorrectly. (OC-13222)
  • Clarified message provided when uploaded form contains item groups that begin with unsupported characters. (OC-13165)
  • Fixed an issue where certain invalid form uploads would fail with an invalid file type error instead of correct error messages. (OC-13138)
  • Updated Vertical VAS to have option to display numeric labels every 10 units to match the requirements of certain validated instruments. (OC-13127)
  • Fixed an issue where the choice filter would not work if the filter evaluation was done before the item became relevant. (OC-12885)
  • Fixed an issue where a loading page could be displayed indefinitely when closing a form. (OC-11467)
  • Added support for the pad2() function to pad a number to 2 digits. (OC-11206)

Participate

  • When a participant edits a form already in progress, they will now be taken to the point of the form where they last left off. (OC-12389)
  • Fixed an issue that could cause calculation items based on a date to display incorrectly on some systems.(OC-14184)
  • Performance of Participate dashboard will be significantly improved when participants have many forms visible. (OC-14052)
  • Fixed an issue where a participant would be unable to move on to the next form after reopening a contact form containing data. (OC-13517, OC-11179)
  • Fixed an issue that could cause the Invite Participant dialog to start defaulting to select invitation by mobile. (OC-12942)
  • Expanded Participate mobile number country selector to include all countries. (OC-12872)
  • Code refactoring to improve performance. (OC-14252)

Randomize

  • Added support for multiple randomizations per study. (OC-13184)
  • Improved stability for randomizations. (OC-12527)

REST API

  • Updated the API to create Event CRFs for associated forms when events are scheduled via this method. (OC-13995)
  • Added new endpoints for tabular and XML import APIs. The prior endpoint is still operational but will be deprecated in the future. (OC-13755, OC-13657)
  • Updated the scheduled job API to appropriately restrict access to the correct site/study admin users. (OC-13546)
  • Updated the scheduled job API to give the correct error code responses and improved messaging in the response bodies in certain cases. (OC-13488)
  • Fixed an issue where it was not possible to lock an event via the API. (OC-13368)

Insight

  • Fixed an issue where Insight refreshes could begin to fail if previously published forms or events containing them were archived in Study Designer. (OC-13357)
  • Added support for new Viewer role to Insight. (OC-14307)
  • Updated the labels recorded in Insight for several Audit Log Event Types to match what is displayed in the OpenClinica Audit Log interface. (OC-13690)
  • Updated Insight to address possible refresh issues. (OC-13359, OC-13358)

General

  • Fixed an issue that could cause a new user’s status to not be updated appropriately in environments with SAML SSO enabled. (OC-14259)
  • Code maintenance improvements for authentication. (OC-14330)
  • Runtime is now called Study Runner in Qualification Reports. (OC-13779)
  • Fixed an issue that was requiring users to login twice on their next login following a session timeout. (OC-11106)
  • Fixed an issue that could inappropriately log users out when navigating between Study Runner or Study Designer and the Study Manager. (OC-11087)
  • Security enhancements.

OpenClinica 4 Stack 12.5 (Release Date – 20 January 2021)

OpenClinica 4 Stack 12.5 contains targeted fixes to OpenClinica. View the entire Stack 12.5 changelog here (login required).

Highlights include:

Changes & Fixes:

  • Updated authentication service to support a custom logout extension. (OC-14142)

Click here to view previous updates