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 http://svn.akazaresearch.com/OpenClinica-3.0-distros/.

– Paul Galvin

OpenClinica 2.5 is Here!

It is with great excitement that I can finally say the production release of OpenClinica 2.5 is here! It took a lot of hard work and dedication not just from our developers, but our testers and community contributors as well.

Please go here to download the latest and greatest offering of the preeminent open source application for electronic data capture and clinical data management. You will need to have an account on www.openclinica.org to download it.  If you don’t have one you can register for one.

In the download package you will find installation scripts for both the Oracle and PostgreSQL databases on both the Linux and Windows operating systems. In addition, for folks currently using version 2.2.1 or 2.2.2, there are scripts to upgrade your instance to OpenClinica 2.5.

Everyone will be able to experience the robust new features of the application including Bulk Data Import, Improved Query Management and Resolution, Cross Form/Cross Field Edit Checks, and Editing/Copying Datasets. Also, we have removed the need for a nightly data warehouse script to run and now you can extract data in real time.

Please join Akaza Research on October 7th for a free webinar introducing OpenClinica 2.5. You can sign-up here:

Webinar @ 19:00 – 20:30 (GMT -5:00)
Webinar @ 9:30 – 11:00 (GMT – 5:00)

Of course we’d highly recommend attending a training course so you too can become an expert user of OpenClinica. Our first open enrollment training on OpenClinica 2.5 is being offered October 15-17.

Thanks again to everyone for making this release a success!

– 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.

OpenClinica 2.5 Release

We are getting very near to the release version 2.5 of OpenClinica, representing a major milestone in the development of the popular open source software for electronic data capture (EDC) and clinical data management. The release contains a number of exciting improvements, including:

–    Rules engine for executing cross-field or cross-form edit checks and triggering notifications to users
–    Scoring calculations (derived values) in case report forms (CRFs)
–    New user roles for monitors and data managers
–    Improved monitoring/query management tools and discrepancy note reporting
–    Electronic signature capabilities
–    Ability to copy and edit previously created datasets
–    Improved auditing and logging capabilities
–    Simpler CRF upload
–    Improved support for CDISC ODM v1.3
–    Support for Oracle DB Backend out of the box.
–    Minor UI and application fixes from OpenClinica 2.2
–    Improved performance and scalability

Over the past 6 weeks the core development team has been putting OpenClinica through a rigorous, validated, QA and testing procedure. There are roughly another 3 weeks of documented testing ahead of us. If you would like to try the latest beta version of the application, please download it from http://svn.akazaresearch.com/OpenClinica-2.5-distros/.

Thanks to everyone in the community who has contributed to this release and provided feedback during the alpha and beta periods!

As we get closer and closer to the production release of OpenClinica 2.5, stayed tuned to this space for additional updates.

21 CFR Part 11, Electronic Signatures, & OpenClinica

Organizations that seek to submit their clinical trial results to the FDA must comply with 21 CFR Part 11: a key set of United States government regulations governing the use of electronic systems in clinical trials. Despite the fact that the government has issued guidance to try and clarify interpretation of these regulations, many people continue to have varying opinions on how software can/should best support 21 CFR Part 11 compliance.

Before I go any further I want to make sure readers understand that software itself can neither be compliant nor non-compliant. It is the implementation and use of software that determines actual compliance. Therefore, one could envision a system without a lot of native features designed to support 21 CFR Part 11 and achieve compliance through the application of Standard Operating Procedures (SOPs) and other controls. Conversely, one could conceive of a system that inherently better supports compliance through specific features.

As a member of the core OpenClinica development team, I have been involved in tackling one of the key pieces of 21 CFR Part 11 guidance that causes a considerable amount of confusion: electronic signatures. As a refresher, electronic signatures are a system feature used to ensure that actions taken by users of a system are attributable in a legally binding manner. 21 CFR Part 11 looks at System Controls, Signature Controls, and Password Controls as components of electronic signatures.

The forthcoming release of OpenClinica (version 2.5) will offer new ways of verifying that the data being provided for a subject is Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA).

Different users in the context of OpenClinica will need to verify the data they are providing are truly accurate and complete. One of the users may have a data entry role. In order to show the data being provided truly is ALCOA this user must enter their password before completing data entry. This will also ensure the user entering the information is in fact the same person that logged into the application in the first place.

An investigator in OpenClinica will need to verify all data are accurate and complete for a subject’s event, or the complete subject “case book.” OpenClinica will allow the user to sign event by event whereby the investigator is stating that all of the information in the CRFs for each event contains original and accurate data. Before signing for the subject’s event or case book, the investigator will be allowed to go through each one of the CRFs to make sure all discrepancies have been cleared up, and all the data are complete.

Every step a user takes to sign a CRF, an event, or the subject case book is being audited in the application so there will always be a record of when each action took place.

This has been a brief explanation of how OpenClinica 2.5 will further support clinical trials where the results will need to be provided to the FDA. The new electronic signatures feature allows users who are implementing and using the software to become more compliant with 21 CFR part 11 requirements.

CDASH: A new way to standardize data elements

Many people who work with EDC systems have heard of or been impacted by CDISC, Clinical Data Interchange Standards Consortium.  CDISC’s mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.  They have many different initiatives, but one of their newest ones promises to aid the development and use of electronic Case Report Forms (eCRFs), the foundation of an EDC system.

Clinical Data Acquisition Standards Harmonization, (CDASH) aims to standardize ways of collecting data in a clinical trial.  The current EDC landscape has hundreds, even thousands, of different eCRFs that capture essentially the same information, but with CDASH’s initiative one common data element can be used for each piece of information collected.

The initiative is not being pushed to enforce the way an eCRF looks and feels; rather, it seeks to standardize the way the fields and data on a form map to a database.  Allowing users to create eCRFs with one standard in mind will allow the users to re-use their work again and again rather than having to create new eCRFs the next time they begin a study.

By mapping OpenClinica CRFs to CDASH content standards (element name, definition, and the related metadata) users of OpenClinica can access a basic set of global data collection fields with semantics agreed upon by representatives from Contract Research Organizations (CROs), Academia, Government and Industry.  These CRFs can be found in the OpenClinica Enterprise CRF Library.