New Capabilities Added to OpenClinica Version 3.1

For the past 12 months, the OpenClinica development team has been working diligently on the next major OpenClinica release. In a prior blog post (OpenClinica 3.1 (project “Amethyst”) Preview), I discussed some of the new functionality and key improvements this forthcoming release will include. Since then, the development team has added some more pieces of functionality, most notably:

  • Re-factoring of Extract Data to enable custom data transformations
  • Discrepancy Note “Days Open” filter
  • Discrepancy Note “Days Since Updated” filter
  • CRF Header updates
  • Additional study parameter configuration options
    • Interviewer Name – not used
    • Interview Date – not used
    • Location – not used
  • OpenClinica Data Mart for ad hoc reporting*
  • GUI-based Rules designer*

Custom Data Transformations

From a development perspective, perhaps the most significant piece of functionality in the above list is the complete re-factoring of the Extract Data module. 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.

GUI-based Rules Designer*

The GUI-based Rules designer is a project currently underway that allows 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.

OpenClinica Data Mart*

The OpenClinica Data Mart presents clinical data from OpenClinica studies in a readily-accessible relational database for ad hoc reporting and analysis. The Data Mart enables data managers, project managers, and researchers to create reports and mine data using standard business intelligence software or SQL reporting tools

Beta Timeframe

We currently expect the first Beta of 3.1 to be available towards the end of November. This Beta will be feature complete, and blocking issues that prevent the testing of new features will have been resolved. Once the first Beta is released, we will begin the 3.1 Pilot Program. We currently have 10 organizations participating in the Pilot Program, but if your organization would like to volunteer as well please contact me.

Please be sure to check back the OpenClinica Blog often as I post future updates on the 3.1 timelines.

– Paul Galvin, OpenClinica Project Manager

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*Both the GUI-based Rules designer and Data Mart will be Enterprise only applications and will not be part of the publicly released 3.1 Beta.

OpenClinica 3.0 Features Preview – Part II

Welcome to Part II of the OpenClinica 3.0 features! I previously wrote about three of the main features for 3.0, Source Data Verification, new User Interface for navigation in the system, and a new Home Page for each user.

This post is about three additional features: (i) the new Build Study module, (ii) setting the length and significant digits of items, and (iii) the improved performance of the Subject Matrix.

In 3.0,  all the study build tools will accessed from one main page following a task-based approach. There are five tasks available to the user at the outset. Once the user finishes these first five tasks, two more tasks will become available (see image). This allows the complete study from CRFs to event definitions to sites to assignment of users be done all from a single page. There is also a checklist to let the user easily see how many tasks have been completed so they know how much more configuration is needed before the study is ready to start enrolling subjects.

Build Study Page in OpenClinica

OpenClinica 3.0 also allows the creator of CRFs to set the allowable length of  text fields including the number of decimal places a REAL number should be rounded to. This parameter is set in the OpenClinica CRF Template in a new field called Width_Decimal. The user will specify the width and decimal for a particular field which will force the user to enter the most precise data as possible in a CRF. No longer will the system round to the 4th decimal place at all times and allow up to 255 characters in the field if the CRF creator does not want them to. For example, the creator could specify that a field should have no more than 5 digits total with a maximum of 1 decimal place by entering 5(1) in the Width_Decimal column of the OpenClinica template. If the data entry person tried to enter 3.4444 or 678913 they would told the value is invalid.

By providing this functionality, OpenClinica will help the users get their data into SAS and SPSS more easily.

One of the most important and information-rich pages in OpenClinica is Subject Matrix page, and OpenClinica 3.0 provides significant performance enhancements on this page for studies with large numbers of of subjects.  From the Subject Matrix page users can see a snapshot of where the subjects are in the study, schedule a new event, view a subject record, view a subject event, enter data in a CRF and sign a subject’s record without having to navigate to different pages in this system. A number of users were reporting sluggish performance with the Subject Matrix when they had 5000 or more subjects enrolled in a study.

OpenClinica 3.0 utilizes a new table structure that allows users to load the Subject Matrix containing over 10,000 subjects and 15 event definitions in fewer than 5 seconds (this process could take upwards of a minute in previous releases of OpenClinica).

Please feel free to download the Beta version of OpenClinica 3.0 at http://svn.akazaresearch.com/OpenClinica-3.0-distros/.