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 3.1 Release Timelines; Call for Pilot Program Participants

Last week I wrote about a few new features that will be part of the forthcoming OpenClinica 3.1 release and promised some information about when we expect to make different phases of the application available. Here is the release timetable we are currently targeting:

  • Alpha Release – June 21st, 2010
  • Beta I – July 9th, 2010
  • Beta II – August 2nd, 2010 (OpenClinica 3.1 Pilot Program)
  • Beta III – September 1st, 2010
  • Production Release – End of September/Beginning of October

The first Alpha release will contain, among other items, the following features mentioned in my previous blog post:

  • Dynamics (Show/Hide/Insert Actions)
  • Relative paths for OIDs
  • Multiple site level users accessing a CRF before it is marked complete
  • Modularization
  • Audit Log and Discrepancy Note Data with ODM Export
  • Discrepancy Note Flag Colors

We will try to also provide some concrete instructions on how to use each of these features before the Alpha is released. Updates to these instructions and additional documentation will be generated after the Alpha has been made available for downloading.

3.1 Pilot Program

As in prior releases, we will be conducting a Pilot Program with selected interested organizations. If you are interested in participating in the OpenClinica 3.1 Pilot Program (or just want more information about it), please send an email to contact@akazaresearch.com.  The Pilot Program is designed to give organizations an opportunity to test out new features of OpenClinica and provide valuable feedback on how the features are working. It was very successful prior to releasing 3.0 where 10 participating organizations received help and support from Akaza while experiencing and learning the new product features firsthand.

– Paul Galvin