Key Features of OpenClinica 3.1

Date Updated: June 1st, 2011

Please find a list of the new features of OpenClinica 3.1, along with a brief summary about each feature, below:

Dynamic Logic with Rules

OpenClinica 3.1 will support Showing and Hiding of CRF Items using both the CRF template and a Rules file. When a user enters data and saves a CRF section, data fields may be shown or hidden based on value(s) the user provided in one or more fields on that form. This capability is also commonly referred to as “skip patterns.” A simple example would be a CRF question asking if the patient is male or female. If the value provided is female, a pregnancy related question could then be displayed to the user entering data and all questions associated with males could be hidden from view.

3.1 will also support Inserting of data into another field based on values provided in one or more fields on that form. The value can be inserted into any other CRF in the event the user is currently entering data for.

Simple Show/Hide in CRFs

In addition to the Dynamics capabilities that will be part of 3.1, we have added a feature called Simple Conditions. This feature is similar to Dynamics in many ways, but can be implemented through the CRF Template directly rather than writing a separately Rules XML document.

With Simple Conditions, a person creating an OpenClinica CRF will have the ability to designate Items as “hidden” from the data entry person’s view until a particular option is chosen for another CRF Item. The data entry person will not have to click “save” on the form–instead, as soon as the option is selected, this hidden field will be shown in real time.An example of the type of use case this feature targets, is a CRF question with two fields, one for “race” and the other for “comments” (which is hidden). If the data entry person selects the value of “other” for the race field, the hidden comments field will be display underneath.

Additional Rules Improvements

New features added to Rules include:

  1. Run on parameters to specify whether the rule will execute during Initial Data Entry, Double Data Entry, Administrative Editing, and/or in Batch
  2. Relative paths where only the item OID must be defined in the rule assignment
    • This enables the reuse of rules across studies and instances
  3. DiscrepancyNote actions will no longer log duplicate discrepancy notes on the item if the target value has not been changed.
  4. The ability to reuse the same RuleDef OID in multiple studies
    • This increases the portability of rules.

Extract Module Changes

In prior versions of OpenClinica, the Extract Data module would natively export CDISC ODM 1.2, CDISC ODM 1.3, both ODM 1.2 and 1.3 with OpenClinica extensions, tab-delimited text, and an SPSS file format. While these formats will continue to be available in 3.1, OpenClinica will have the ability to process (via XSL style sheets) any CDISC ODM 1.3 data set into any other data format.

This new XSL method of extracting data from OpenClinica opens up a new world of formats in which data may be obtained from OpenClinica. To create a new extract format, all one has to do is configure a new XSL style sheet. Organizations can write their own XSL style sheets then configure a file called extract.properties that allows OpenClinica’s XSL transformation engine to convert the data in the ODM XML file into the organization’s desired format.

Please see the informative blog post submitted by Cal Collins for additional information.

New Enhancements Added to Discrepancy Notes

The following list bullets the improved use of Discrepancy Notes in OpenClinica 3.1

  1. The flag color will reflect the status of the Discrepancy Note
    • Red = New
    • Yellow = Updated
    • Green = Resolution Proposed
    • Black = Closed
    • White = Not Applicable
  2. New Filters on the View Notes main page
    • Days Open
    • Days Since Updated
  3. Ability to respond to discrepancy notes from the View Notes table
  4. If you choose to respond to a discrepancy note by going directly to the source, when you return the filters and sorts you have set on the View Notes table will persist
  5. Ability to assign Failed Validation Check type discrepancy notes
  6. Print and Download of discrepancy notes will reflect the filters applied to the View Notes table
  7. The Discrepancy Note Matrix has been removed to end confusion with the Subject Matrix.

Site Level Users Allowed to Access Started CRFs

OpenClinica 3.1 will allow different site level users access to an Event CRF, even if they are not the conceptual “owner” of that CRF. In prior versions of OpenClinica, once a user began data entry in a CRF, the system prevented other users from adding information or data to the CRF until it had been marked complete. The new feature will allow a second user to continue entering data before the CRF is marked complete.

This change to OpenClinica will also help facilitate the ease of recording adverse events in a separate CRF. A user will not have to mark it complete in order for another user to provide additional adverse events that have occurred for a particular subject. In addition, this new functionality will prevent users from accessing an Event CRF if another user already has the form open. In this case, the second user will receive a message saying that the form is currently being accessed by another user

Modularization

Modularization is defined as a software design technique that increases the extent to which software is composed from separate parts, called modules. Conceptually, modules represent a separation of concerns, and improve maintainability by enforcing logical boundaries between components.

What this means for OpenClinica is we have started to separate the application into multiple pieces. In version 3.1, we have modularized the web application from the web services functionality. This will allow new web services to be developed on separate release timelines from the main web application, facilitating the system’s extensibility.

In addition, we are releasing some new web services with 3.1:

  • CRF Data Import
  • Retrieve a list of studies
  • Retrieve a list of events and their CRFs
  • Retrieve a list of subjects and their events

New Enterprise Features

Rule Designer Interface

The GUI-based Rules designerallows users to build cross-field/cross-form multivariate edit checks without having to interface directly with XML. Its intuitive, drag and drop interface hides much of the current complexity in creating and managing Rules, while retaining the system’s robust capabilities in this area. Users will be able to work directly with the Item Names as defined in a CRFs definition, eliminating the need to keep track of OIDs.

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