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Does EDC Help or Hurt Site Relations?

Getting reluctant clinical research sites to embrace technology such as electronic data capture (EDC) software can be difficult. This is a recipe for troubled relationships between the sponsor/CRO and sites. However, just as it is possible for a poor EDC implementation to erode sponsor-site relations, it is also possible for the EDC software to help cultivate improved relationships. Take a look at the new whitepaper, “Improving Site Relationships through EDC” to learn about some important considerations when thinking about site relations in the context of EDC.

OC13 – OpenClinica 2013 Global Conference draws clinical research community to Boston

OC13 is an educational event open to anyone looking to obtain insight into the OpenClinica clinical trial software platform, learn useful new skills, and build relationships within the vibrant OpenClinica community. This year’s event features best practices, case studies, demos, and hands-on activities. View the conference program to choose from a list of valuable sessions such as: “Utilizing CDISC Standards to Drive Efficiencies in Study Set-up and Build,” and “The Changing Face of Clinical Trials – Patient-Centered Research,” to a sneak peak at exciting future developments for OpenClinica.

Attendees can also choose to participate in a set of hands-on workshops and training classes. These workshops deliver highly-relevant information on key subjects such as regulatory compliance and validation, web services and integration, edit checks and rules, and moving from paper to electronic data capture (EDC). For a more thorough understanding of OpenClinica, you can take full “Central User” or “Developer” training on this robust platform.

Early bird registration is available until March 22.

Kicking-off the conference as keynote speaker is Douglas Bain, a recognized veteran in the eclinical industry who has worked in a leadership role with many prominent clinical research technology leaders. In his address, Mr. Bain will focus on the emerging dynamics of patient-centered clinical trials.

“I am thrilled to deliver the keynote at this year’s OpenClinica conference,” said Mr. Bain. “Clinical research modalities are changing, and I look forward to sharing my insights into where things are headed with such an innovative community.”

Conference attendees are invited aboard the Odyssey for a dinner cruise and unique views of the city from Boston Harbor.

Also in Boston, immediately following OC13, is the 49th DIA Annual Meeting, June 23-27 at the Boston Convention and Exhibition Center.

About OpenClinica

OpenClinica is the leading open source clinical trials software platform, and increases the quality and pace of clinical research worldwide. With a global community of users and thousands of implementations, OpenClinica presents a compelling way to obtain greater value in clinical trials. The OpenClinica software is backed by Waltham, Massachusetts-based OpenClinica, LLC, who provides commercial grade support for the open source platform. For more information – including product downloads – visit http://www.openclinica.com or follow @OpenClinica on Twitter.

OC13: OpenClinica 2013 Global Conference

We’re gearing up for a fantastic conference, June 21 in Boston. You don’t want to miss the informative workshops, sessions, and demos that will help you optimize your research based on the cutting-edge OpenClinica open source platform. And, Doug Bain from eClinicalHealth is planning an engaging keynote presentation that covers the critical movement toward patient-centric trials. Oh, and I should mention the amazing dinner cruise on Boston Harbor.

Haven’t registered yet? Get a jump on it (and a discounted fee).
Early-bird Registration >>

I need some training!
Sign up for Training >>

Get invaluable practical experience.
Sign up for Workshops>>

I have something great to share.
Submit a Session>>

Show off your work.
Get a Demo Table>>

Have a blast!
Welcome aboard the Odyssey Dinner Cruise>>

OpenClinica 3.1.3 Now Available

We are thrilled to announce the general availability OpenClinica 3.1.3. This latest release of the OpenClinica clinical trial software provides over 100 fixes and enhancements, including:

  • Improved performance and stability, including 80% increase in max user load and 40% faster page turn times
  • Numerous improvements to OpenClinica’s internationalization/localization support
  • Support for CRF version migration of individual event CRFs
  • Enhanced security with strong password configuration options
  • Greater reliability when entering or editing data in repeating groups
  • Ability to run rules at data import and when loading data via web services
  • Fixes to nested simple conditional displays in CRFs

For a more complete overview, you may view the 3.1.3 release notes.

Download OpenClinica 3.1.3 Community Edition

2013 Training Schedule

We have recently posted the 2013 schedule for open enrollment Central User Training at:

https://www.openclinica.com/open-enrollment-training

Central User Training is an intensive, comprehensive 4-day course that teaches students how to use the application from the perspective of all user types.

Open enrollment courses are open to any person who is interested in attending, and is appropriate for both users of the Community Edition and Enterprise Edition.

We also regularly organize private classes as needed.

OpenClinica 3.1.3 Release Preview; Beta Now Available

We’ve been working hard on the OpenClinica 3.1.3 release and recently published a beta release. While 3.1.3 is technically a maintenance release, it is quite substantial, covering 176 fixes and enhancements. The following is a summary of what’s included. For a more complete and detailed list, please view the Project Roadmap page in the Issue Tracker (login required).

  • Improved performance for CRF data entry/editing, the View Study Subject page, and the Notes and Discrepancies page
  • Fixes and improvements to SPSS output format
  • Improved server stability
  • An overhaul of OpenClinica’s internationalization/localization support to fix defects and increase ease of use.
  • Fixes to problems with data entry/editing in repeating groups
  • Support CRF Version migration for individual event CRFs
  • Rules can be run at data import and when loading data via web services
  • Fixes to nested simple conditional displays in CRFs
  • Option to require strong passwords
  • Fixes to missing database constraints for OpenClinica installations upgraded from 2.5 or earlier

Beyond Single-Selects – Managing Long Lists in OpenClinica

Here at the VU Medical Center Amsterdam, we’re implementing OpenClinica (OC) for CTMM TRACER. TRACER aims at improving diagnosis, prognosis and therapy selection for rheumatoid arthritis. A series of eCRFs are being developed, ranging from questionnaires to joint scoring and DAS-score calculations.

One of our most recent CRFs is concerned with a patient’s medication. In this CRF one of the items of interest is the medication the patient is currently on. The code system employed for medication is the Anatomical Therapeutic Chemical (ATC) Classification System, which contains over 500 entries. Initially, we intended to create a single-select field containing the ATC codes and their description. Unfortunately, the number of characters involved is way more than the maximum of 4000 allowed by OC. The easy alternative would have been to define a free text field, but it is generally best to avoid those, as the data in these fields tends to pollute easily.

The solution we created employs JavaScript and JQuery. Without getting into the technical details (you can get them here), the approach is to create a (read-only) text field in OC and let a non-OC single-select item write data to this field. This ensures that the values written to OC are limited to those specified in the list, without having to store the complete list in OC. The list entries themselves are stored in an external XML file, which is stored on the OC server. If at some point the ATC-codes need to be updated, we can simply update the XML file and the updates will be available for the users.

Whereas our problem was concerned with a long list of ATC-codes, the solution can be applied to any list which is longer than OC’s maximum number of characters. All you have to do is create an XML file, which describes the list, make some minor changes to the example code provided on the wiki page and upload two files to your OC server.

Sander de Ridder (MSc Computer Science, MSc Bioinformatics)

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