OpenClinica 3.0 Features Preview: Part III

Welcome to the 3rd and final installment of the OpenClinica 3.0 features preview!  This post covers the new Web Services interface that is part of 3.0 and the job scheduler that can be used to automate Data Import and Data Export jobs.

OpenClinica 3.0 allows for programmatic interaction with external applications to reduce manual data entry and facilitate real-time data interchange with other systems.  The OpenClinica web services interface uses a SOAP-based API to allow the registering of a subject and scheduling of an event for a study subject.

OpenClinica provides a WSDL (Web Service Definition Language) that defines a structured format which allows OpenClinica to accept “messages” from an external system. For example, an EHR system could register subjects for a study in OpenClinica without direct human intervention. At the same time, the EHR could also be programmatically scheduling study events for these subjects. More information about the OpenClinica API can be found on the OpenClinica developer wiki.

An early reference implementation conducted by clinical lab Geneuity used the API to create a web service which inserts data programmatically into OpenClinica CRFs directly from laboratory devices. See the post by Geneuity’s Colton Smith below.

Another major productivity tool in 3.0 is the introduction of a Job Scheduler for automating bulk data import and export.  With this feature users can define a job that will generate an export at a specified time interval.  The Jobs Scheduler can also be configured to regularly scan a specific location for CDISC ODM files and run data imports when a new file is available. This feature can be particularly helpful in automating routing functions, such as the incorporation of lab data into OpenClinica from an external system.  The lab data does need to be in a valid CDISC ODM format (this can be accomplished via another great open source tool called Mirth), but it does save a person from entering data in two applications separately.

At time of this post, OpenClinica 3.0 is currently released as a beta3, but the production ready application is soon to follow. The application is passing through the highly rigorous strictures of our quality system (think Navy Seals training for software) and the output will be fully validated and ready of use in roughly a month. Needless to say, I, and everyone else here at Akaza is very excited to be so close to releasing 3.0. It is already quite clear that this release will have a momentous, positive impact on the community.

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

OpenClinica 3.0 Features Preview – Part I

We have been working hard on OpenClinica 3.0 for the last 9 months and are getting closer and closer to a production release ready for use in live clinical studies. In the meantime, I wanted to talk about some of the new features over the next few weeks to let folks know what is coming.

OpenClinica 3.0 is sure to bring a lot of excitement to all users of the rapidly growing open source electronic data capture system. A lot of focus in this release has been put on the way trial sponsors use an EDC system and I’d like to point out some of the new features that should enhance their user experiences.

OpenClinica 3.0 will provide a new home page to study-level users providing key information about the progress of a study. These users will be able to see a summary of the subjects enrolled at each site compared to their expected total enrollment as well as the overall subject enrollment for the complete study. Also, these study-level users will be shown a count of the number of study events that are in a particular status. A summary for the number of subject statuses will be displayed so the study-level user can easily see how many subjects are signed, source data verified etc.

OpenClinica 3.0 will provide monitors a workspace to source data verify subjects and their data. The workspace will allow users to source data verify information collected at each visit one-by-one, or verify the information in a bulk process. These two options allow the monitors to perform remote source data verification daily for subjects in the study. Or, if the monitor has to be on site to review and verify information, he/she can go back to their hotel room and check-off verification for many subjects and events at once so they do not have to go one-by-one through every subject and event CRF.

The top-level navigation in OpenClinica 3.0 has been streamlined so site users of the application understand exactly what they have to do after they login. A new home page for investigators and clinical research coordinator users will show the number of queries assigned to them with a link to see every Query assigned them. The home page will show the 5 most recent queries to give the user an idea of what they need to respond to that day.

The new navigation points to the 3 main actions the site users should take. The “Subject Matrix” link will bring them to the new and improved subject matrix in OpenClinica. This matrix will allow users to easily add subjects, schedule events and even enter data from a single, powerful screen. The “Add Subject” link will bring them to a page where they can add a new subject to the study. “Notes & Discrepancies” will bring them to a page where they can see all the queries for their site and allow them to provide a response.

Above is just a small sample of the new features in OpenClinica 3.0. Like I said, I will plan on posting additional features once a week so be sure to check back often. In the meantime, please feel free to download the alpha2 at

– Paul Galvin

OpenClinica 2.5 – the final countdown!

OpenClinica 2.5 has been going through rigorous testing over the last few months and we are finally getting close to releasing a production ready version of the application.  There are currently 2 betas and 1 alpha available to the community, but shortly we will be having a Release Candidate available that has been subjected to full, rigorous testing procedures.

This Release Candidate will also contain scripts that will allow OpenClinica to run on the Oracle 10g database for the first time as part of a downloadable package.

As you can see below in another post about the release of 2.5, I mentioned it would be on August 29th.  Mea culpa. Clearly, however, it is more important to issue a software product that has been fully tested (and retested) rather then putting a marginal product out just to meet a date. If only Microsoft realized this 🙂

The release candidate will be available to the general public on Wednesday morning, 9/10/2008, and we will be targeting a full production release within the coming weeks.

As we get closer to the production release, please check back for more updates. In the meantime here’s some Final Countdown inspiration from Europe.