OpenClinica 3.1.3 addresses a large number of issues discovered with 3.1, 3.1.1, and 3.1.2. There are well over 100 changes included in this release. It is highly recommended that all OpenClinica users upgrade as soon as possible. The most notable fixes and improvements are summarized below (or, view the complete changelog).
- Support CRF Version migration for individual Event CRFs (#13508)
- Rules can be run at data import and when loading data via web services (#12344)
- Option to require strong passwords (#14506)
- Reference a CRF via an ODM-based URL (#12343)
Changes and Fixes
- Overhaul of OpenClinica’s internationalization/localization support to fix defects and increase ease of use. (#13713)
- Fixes to problems with data entry/editing in Repeating Groups (#13135)
- Improved performance for CRF data entry/editing, the View Study Subject page, and the Notes and Discrepancies page (requires changes to Tomcat memory settings) (#12079, #14508, #13347)
- Fixes and improvements to SPSS output format (#13051)
- Improved server stability (#13714)
- Fixes to nested simple conditional displays in CRFs (#12827)
- Fixes to missing database constraints for OpenClinica installations upgraded from 2.5 or earlier (#15256)
- Ability to use greater than/less than operators to filter by Discrepancy Note age/days open. The function was not working correctly, will be added back in a future release.
- Ability to cancel a Job that has already started running. The function was not working correctly. Queued Jobs can still be cancelled.
- Download (OpenClinica.com login required to download)
- OpenClinica Reference Guide
- Community Edition installation instructions
- If you originally started using OpenClinica with version 2.5 or earlier, your database schema needs attention. Be sure to follow the instructions in issue #15256 and review issue #13424.
Below is a list of known issues in the 3.1.3 version of OpenClinica.
- Validation/Edit Checks: During Initial Data Entry, the system-3.1.3- prevents saving data in CRF Sections containing blank required fields or fields containing Simple Validation Checks with non-conforming data even after creating a Discrepancy Note(DN). This phenomenon happens for both repeating and non-repeating Items. However, this issue is not observed for Double Data entry and Admin Editing modes. A mitigation | workaround is to use Rules instead of Simple Validation Checks or have users enter a Null Value code to circumvent the validation (this requires that the Event Defintion CRF have Null Values configured). For more details refer to Issue 16415.
- Password Settings not preserved on upgrade from pre-3.1.3 version: OpenClinica now allows an administrator to configure the password policy for your OpenClinica system via a page in the user interface. However the previous settings from your datainfo.properties file for password expiration and change initial password required will not be preserved upon upgrade. You should go into the admin UI and re-set the password settings to the desired settings post-upgrade, then re-start Tomcat.
- Hiding Fields on Items in Repeating Groups – Due to issues with the implementation of hidden fields in Repeating Groups, we do not recommend hiding individual fields within a repeating group of items in a CRF. Usage of the hidden items in repeating groups works as expected in initial data entry phase, but is problematic after a CRF is marked complete. If hidden Items in Repeating Groups do not get displayed after the CRF is completed, unexpected behavior may occur. The following issues fall under this category: 12052, 12058, 12095, 12102, 12109, 12098, 12074.
- Data Entry in Repeating Groups – During the administrative editing phase; entering Discrepancy Note(s) on the last added row of a Repeating Group will cause the Discrepancy Note(s) to be saved to the first row. Also, saving data on the last row of the displayed Repeating Group that is a part of Rules target triggers an alert that prevents user from going to the next section. The following issues fall under this category: 12108, 12091, 12174.
- Population of Group-calculation Fields – Group-calculation values are not populated immediately upon saving a CRF section with the group-calculation inputs. It is not until you hit Save on the subsequent section that contains the the group-calculation field that the field updates correctly. This behavior can cause problems if you are have a rule targeted on the group-calculation item, since the rule may evaluate before the group-calculation value is populated. This issue does not exist in 3.1.2. 16551.
- Internal CRF Navigation Broken when using RESTful URLs – If you use the RESTful URL for a multi-section CRF, then click the tab of another section after you get there, or if you use the drop down to navigate, the link is broken and you will get an error, “404: Page not found [Invalid case report form OID]”. Refer to issue 16174.
- Data Import with Partial Dates – When importing data values for items of type ‘Partial Date’, OpenClinica will not import partial date data values formatted in the expected manner YYYY-MM-DD. The data type must be provided as DD-MMM-YYYY format in the XML. Refer to issue 11617.
- Filtering on Administer Subject page – The search filter criteria (such as Person Identification Number) on the Administer Subjects page does not return Subjects that meet the requested criteria. For the time being it is recommended that users utilize column sorting on the Administer Subject page in order to locate records. Refer to issue 11966.
- Extract Data Problems – There are a number of minor known Extract related problems. Currently, data extracts may fail if certain characters (such as “*” or “?”) are included as a part of dataset name. Also, certain characters, if present as data values in a CRF, will be extracted incorrectly. Issues that fall under this classification are 11874, 11409, 11387, 11389. Other miscellaneous Extract-related issues include: 11419, 11961, 14158 (affects OpenClinica Enterprise Datamart only), 12422.
- Filter issues on the Subject Matrix > View by Event page – On the Subject Matrix > View by Event page, only the “initial data entry” status filter is functional. Filtering by other statuses will not work. Issue 12336.
- Unexpected Error page for ‘Go Back to Site’ – When selecting ‘Go Back to Site’ link after editing Site information, you may get an unexpected error page. The workaround is to click “Exit” rather than “Go Back to Site List”. Issue 12228.
- Duplicate Alert Message for Restore CRF – Restoring an event CRF causes a duplicate notification message. Issue 12237.
- Leaving Data Entry Unlocks all CRFs that were locked for a User Session – The logic that unlocks a CRF when the user leaves the data entry page for a given CRF will release any other CRF locks this user may hold. Issue 13950.
- Unexpected Error page – When selecting ‘Go Back to Site’ link after editing Site information, you may get an unexpected error page. The workaround is to click “Exit” rather than “Go Back to Site List”. Issue 12228.
- Duplicate Alert Message for Restore CRF – Restoring an Event CRF causes a duplicate notification message. Issue 12237.
- Outlook Emails with Links to Datasets – OpenClinica supports email notifications when data sets have completed running. The user may experience an error when clicking on the link to download the file if (a) the email is accessed in Microsoft Outlook, (b) the default browser for the user is Internet Explorer, and (c) the user is currently logged into OpenClinica. If the error is encountered, the user should navigate to the dataset from the OpenClinica home page and download the file from the application.
- Site Unique Protocol IDs – Site Protocol IDs must be unique across a Study and can not share the Study unique protocol ID. This is neccessary to allow the web service of registering a Subject and scheduling an Event to work properly.
- Rules / Dynamic Logic – Rules containing the absolute full target path may sometimes cause the rule to fail. This issue is mitigated by uploading the CRF Item OID instead of the full path. Refer to issue 11803 for more information.
- Discrepancy Note Tooltips when Viewing CRFs with Repeating Groups – There is new functionality in 3.1 for the Discrepancy Note tooltip where information about the Item name is displayed, a summary of the Discrepancy Notes on the item and whether an audit log history exists for a particular Item. This does not work 100% accurately when a Repeating Item has a Discrepancy Note assigned to it. It will not show the summary of the Discrepancy Note information or the fact an audit log exists. It will show the Item name for the Item at all times. Please refer to issue 9345 for more information.
- Password Required to Mark CRF Complete – During the creation of an Event definition, the user can define whether the system will require a user to enter their password before marking a CRF complete. If this feature is enabled, the user will see a popup box to enter their password after choosing the Mark CRF Complete checkbox.
However if the user hits the ‘Enter’ key on their keyboard without entering a password, the form will be saved without a password being entered. Please see issue 9340 for more information.
- Validation Messages for Calculations – If a user encounters a validation error message pointing to an Item defined as a calculation, they will not be able to click on the message to be brought to the field. Due to the fact the user can not edit calculated fields, the application will not direct them to field. Instead they must scroll down the page to find the red exclamation point (!) for the calculated value and provide the Discrepancy Note. This issue exists with OpenClinica 3.1.3 as well. Issue#: 13529 is associated with this.
- Component Data Model (with class diagrams)
- Data Model
- Source Code
Release Notes 3.1.3 Presentation
The Release Notes 3.1.3 presentation slides link is as follows: