The Evolution of Electronic Data Capture

OpenClinica was recently featured in an article in Genetic Engineering and Biotechnology News titled “Commandeering Data with EDC Systems,” written by Dr. James Netterwald. The article briefly recounts the early days of clinical trial Electronic Data Capture (EDC). But how far have we come? Dr. Netterwald’s title (perhaps unintentionally) conjures up images of struggle and strife, which may be perhaps more a more apropos description of the journey of Electronic Data Capture than it may first appear.

As an industry, it’s taken us a good 20 years to get to where we are, and to be plain, it’s been a slow start. (In my own defense, I, and my company Akaza Research, have only been a party to the industry for the last 5 of those 20 years.) Climbing the evolutionary ladder from shipping laptops to sites to keying data into electronic case report forms is certainly progress by any measure. However, while the days of mailing tapes and disks are over, the days of real electronic data capture are yet to come. Today, most experts agree that somewhere between only one-half and two-thirds of all new clinical trials use EDC software, an of this only a very small fraction are “e-source,” defined as collecting data in electronic form at its source as opposed to keying it in from some other source. In some ways it is ironic that cutting-edge biopharmaceutical technologies are developed themselves with technologies that are, relatively speaking, much further down the technology food chain.

Notwithstanding, there are some enterprising few who have pushed the pace towards true EDC. Spaulding Clinical, a large phase 1 unit in West Bend, Wisconsin has developed a system that automatically captures ECG data from their facility’s patients and directly populates the clinical trial database with these data. A patient wears the ECG device and the data are transmitted wirelessly to the EDC system. However, this slick and highly productive solution was not developed by either the ECG vendor or the EDC vendor. It was developed by hand by one of Spaulding’s own software developers.

Why isn’t this type of solution more commonplace in clinical trials? What prevents the industry from making the most of today’s information technology? With the strong incentives currently in place to make research more efficient, our field could certainly benefit from some more forward thinking.

– Ben Baumann

The Open Source Effect: Akaza Research Provides Insight into Rapid Growth of OpenClinica

OpenClinica has seen a surge in usage over the past year, according to recent survey conducted by Akaza Research.

“Our annual survey of the OpenClinica community showed strong expansion in all key measurements of system usage,” said Cal Collins, Chief Executive Officer at Akaza. “In the past year we have seen doubling in the number of OpenClinica users and subjects, and a nearly 10-fold increase in regulatory submissions.”

The company reports that a reported 168,989 subjects have been involved in OpenClinica-powered clinical trials, a 224 percent increase from the prior year. In tandem, the company identified a 246 percent increase in the number of OpenClinica software users. The figure measures users working at the sponsor or CRO level and does not include users at clinical trial sites.

“Since these figures are based on a voluntary survey of the OpenClinica community, they are likely underestimates,” said Collins. “While it can be difficult to precisely measure the usage of freely distributed open source software, they provide a clear indication of the growth in OpenClinica adoption around the world,” he added.

The Professional Open Source Model

OpenClinica stands in stark contrast against the landscape of other EDC products that are provided under a closed source license. Akaza Research’s “professional open source” business model makes OpenClinica available in two editions. The OpenClinica Community Edition is freely available to use and modify, and may be downloaded form www.openclinica.org. The OpenClinica Enterprise Edition is a certified build of the open source technology commercially supported by Akaza Research. In many respects, the company’s business model is similar to that of RedHat (Linux), MySQL (database software), and other open source companies.

The OpenClinica rapidly growing open source community currently comprises over 10,500 users and developers, many of whom help review and adapt the open source software. Roughly 33 percent of OpenClinica users are located in North America, 30 percent in Europe, 14 percent in Asia, 9 percent in Africa, 7 percent in South America, and 7 percent in Australia. OpenClinica community members drive much of the product’s evolution, and in recent years have helped to usher the technology into a wide variety of clinical trial settings.

Worldwide Acceptance in Regulated Trials

The composition of the OpenClinica community is changing over time, with an increasing number of OpenClinica users representing commercial clinical trials. Currently, 55 percent of the OpenClinica community members identifies themselves as working in industry, with the remainder in academic or government settings.

According to Collins, “the robust overall growth is highlighted by an increasing proportion of OpenClinica users representing pharmaceutical, biotech, device, and other companies. We saw a 975 percent increase in OpenClinica-powered trials used in regulatory submissions in the past year, and in the next 12 months OpenClinica adopters expect to increase this number by another 200 percent. This is consistent with our OpenClinica Enterprise Edition customer growth, where a majority of new customers are from industry.”

For more information about OpenClinica see the OpenClinica website.

OpenClinica CRF Library

UPDATE (03-May-2010): The CRF Library is now live at library.openclinica.org.

Our vision at Akaza Research is to accelerate clinical research through open technology infrastructure. We do this through an open source software license, supporting a participatory community, and adhering to published open standards.

We are nearing another milestone that will further this vision. The OpenClinica CRF Library, currently in the final stages of development, will allow users to find, share, and re-use case report forms (CRFs) for OpenClinica. By utilizing the OpenClinica CRF Library, users will be able to:

  • Enable faster study startup by accessing a well organized, searchable database of OpenClinica CRF templates
  • Promote data standardization within their organization through re-use of CRFs that adhere to open industry standards
  • Derive customized versions from standardized CRF templates simply by editing the OpenClinica CRF Templates
  • Minimize time and cost spent on study training, testing, and validation by accessing value-added resources and documentation (including implementation guides, CRF Completion Guidelines, and test scripts) associated with the CRF templates in the library.

The library will be searchable by keyword and browsable by CRF type. Most CRFs are derived from authoritative, public standards sources such as the CDISC Clinical Data Acquisition Standards Harmonization (CDASH) initiative and the National Cancer Institute’s Cancer Data Standards Repository (caDSR).

In keeping with our vision, the CRF Library is the product of a participatory community and is based on open source software. Last April, we assembled a volunteer Steering Committee to guide development of the library. Committee members Liz Watts of Starfire Research, Lori Brix of Silent Partners, Derek Wimmer of Wimmer Clinical, and Elisa Priest of Baylor Research Institute have worked scrupulously to identify content, develop supporting materials for the CRFs, and implement workflows that will ensure quality resources. Their substantial knowledge of the CDASH standard and data management expertise has been invaluable. The broader community has also had a hand in building out this resource, through the user mailing list and at meetings of the OpenClinica Community Virtual Forum.

Content & Quality

One of the first questions the Steering Committee asked was, ‘How do we manage quality of content and metadata?’ There are many community-driven, peer-review, and commercial validation models that could work, from a loose ‘wikipedia’-style structure to more rigid frameworks for curation and standardization. We needed to adopt the right mix for our content and our community. The Committee emphasized the need for a high-quality ‘core’ set of CRFs that have broad applicability across studies, align to leading standards, and are accompanied by detailed resources which aid in implementation. At the same time, a larger, more diverse repository of CRF content would make the library useful to many in the OpenClinica community.

The result of this has been to create two broad classes of CRFs in the library, Curated CRFs and and Non-Curated CRFs.

Curated CRFs have gone through a rigorous peer review, testing, and annotation process. They include enhanced metadata, detailed specifications, validation test scripts, enhanced edit checks, and reference documentation such as an Implementation Guide and CRF Completion Guidelines. The initial collection of Curated CRFs in the library will be aligned with the CDASH Domains. The intent is to make it as easy as possible to implement these CRFs into a study, in ‘as-is’ or customized form, with confidence in the quality and accuracy of the CRF.

Non-Curated CRFs will be contributed by members of the community who wish to share their CRFs with others, or will be derived from existing non-proprietary electronic sources such as the National Cancer Institute’s Cancer Data Standards Repository (caDSR). These CRFs undergo less formal review and testing and have fewer supporting materials, instead will rely more heavily on community feedback and annotations.

Because of the significant investment made in annotation, review, and testing, full access to Curated CRFs and all the associated metadata, documentation, and associated resources will be available only to OpenClinica Enterprise Edition Subscribers. Non-Curated CRFs, and limited versions of Curated CRFs without detailed metadata or documentation will be freely available to all members of the OpenClinica community.

Contribution

Based on past discussions on the OpenClinica mailing lists and the Community Virtual Forum, we see substantial interest among community members in contributing and sharing CRFs. This is a very exciting prospect, and we will need community members to contribute enough quality CRF content to make the approach viable. Many community members have expressed interest in sharing their CRFs for others’ benefit, but also identified it as a way to get feedback and improve the forms for their own purposes. To provide a foundation for such contributions, the CRF Library will adhere to the following principles:

1) Contributors will be appropriately attributed and recognized for their contributions. Creative Commons (http://creativecommons.org/) provides widely used guidelines and license agreements to enable this type of sharing. CRFs in the library or derived therefrom will be made available under the Creative Commons Attribution 3.0 License. Contributors must represent that they (or their organization) have the legal right to contribute a CRF, and are not infringing on someone else’s copyright. When featuring the most popular or most highly rated CRFs, the CRF Library will highlight the identity of the contributor (at least by screen name).

2) Members of the community will be empowered to build on and improve others’ contributions for the benefit of all. All community-contributed CRFs will also be freely available to community members, and we will put into place popularity, versioning, and annotation features to allow users of a CRF to provide feedback and/or modifications to the original author.

Next Steps

As I mentioned at the start of the post, we are approaching roll-out of the CRF Library within initial CDASH-based content, and starting acceptance of community contributions. The roll-out will be aligned with the OpenClinica Global Conference (March 22nd in Bethesda, MD USA) and the CRF Library will be a featured topic at the event. It’s been a long time in development and we are excited to be nearing this milestone!

OpenClinica Community and Enterprise Editions

Dear OpenClinica Community,

We are only hours away now from the general release of OpenClinica 3.0. There is a ton of excitement here at Akaza as we get ready to see many months of hard work come to fruition.

In advance of this milestone I’d like to describe a few changes we’re making to how OpenClinica is organized and how the name and logo can be used.

A brief background: As a founding member of the OpenClinica® open source community, I constantly strive to ensure that our technology has a reputation for meeting the highest standards of quality. The growth of OpenClinica® over the past few years is a testament to some success in that area. In my role as CEO at Akaza Research, a business that has invested millions of dollars into development of this open source technology, I recognize that the same reputation of quality is critical to our ongoing success. Part of how we maintain this reputation is to provide quality control over solutions that bear the OpenClinica® name. To enable this, Akaza Research owns the registered trademarks for OpenClinica® and Akaza and reserves the rights to their use.

With the release of 3.0, we are publishing a trademark policy on our website (also summarized below) that defines how the OpenClinica® and Akaza Research® trademarks may be used by members of the OpenClinica community. Our goal is to protect the quality of the OpenClinica® and Akaza brands without inhibiting the freedom that comes with the open source software model. These trademark terms complement the flexibility of open source licensing, by clarifying and creating confidence in the quality and reliability of solutions that bear the OpenClinica® name.

The most visible way the policy will be manifested is by separating the Community and Enterprise editions of the software. The default software download from OpenClinica.org is the Community Edition, pre-configured in a way that complies with the requirements of the trademark policy. The policy itself covers allowed uses of the trademarks for commercial and non-commercial purposes, both for modified (derivative) works and for unmodified versions of the software.

Akaza’s OpenClinica Enterprise customers and partners will be granted separate licenses that include additional permissions on how they may use the trademark in their marketing, operations, and services activities. Their installations will be distinguished as “OpenClinica Enterprise Edition” via the label in the footer of their OpenClinica pages.

I want to stress that 100% of the core OpenClinica source code remains free and under an open source software license. It is our promise that this will always be the case. Over time Akaza will offer additional proprietary services and technology offerings as part of the OpenClinica Enterprise Edition to complement this core, but it is our goal to ensure that the Community Edition always stands on its own as a fully-functioning, 100% open source EDC/CDMS platform.

I hope you share my view that this new policy will provide the clarity and confidence that allow OpenClinica to continue to thrive, without imposing undue restrictions on members of the community.

With that (too lengthy) introduction, here is a summary of the policy. Click here for the detailed, legal version:

CategoryDescriptionTerms and Conditions
OpenClinica Community EditionYou download and install the software on your own, and are not commercially supported by Akaza.You may not use the OpenClinica brand for marketing or sales purposes, and must include the community edition disclaimer.
OpenClinica Enterprise EditionYou are an OpenClinica Enterprise System Level Support subscribers. Other Akaza customers/partners and OpenClinica code contributors may meet the requirements of this category. Contact sales for more detail.Includes limited use of the OpenClinica brand for marketing and sales purposes, ongoing support, and display of “OpenClinica Enterprise Edition” in footer.
OpenClinica Community Edition – Derivative WorkYou download and install the software on your own, make modifications to the code, and are not commercially supported by Akaza. You want to keep the OpenClinica name/logo in the modified version.You may not use the OpenClinica brand for marketing or sales purposes, and must include the community edition disclaimer.. You must also clearly state the software has been modified and the modifications are not supported by Akaza.
Other Derivative WorksYou choose to strip out the references to the OpenClinica and Akaza names and logos from your modified version of the software. The trademark policy does not apply.The OpenClinica source code is licensed under the GNU Lesser General Public License (LGPL). You still must follow the terms of the LGPL, including copyright attribution and requirements for redistribution of source code. Of course, if you choose to follow this course, we hope you’ll also let us know about your software modifications and will contribute these back to the core repositories, both for the benefit of the community and to help ensuring future compatibility of your flavor of the software.

If you are a community user of a prior version of OpenClinica and do not intend to upgrade to the latest release, please contact us if you have questions about how the new policy may affect you.

Best Regards,

Cal Collins

CEO, Akaza Research

OpenClinica 3.0 Completes Functional Testing; Enters Deployment Testing

OpenClinica 3.0 is almost here! The quality team has successfully completed functional testing and has moved onto the phase of software quality assurance called deployment testing.  Deployment tests cover 8 different target “platforms” that range from a clean installation of OpenClinica 3.0 on a Windows server using Postgres, to upgrades of OpenClinica 2.5 to 3.0 on a Linux machine using an Oracle Database. Of course, we also test on all combinations in between.

Before the production version of the application can be released, it must successfully pass through our Quality System. For those of you familiar with such a thing, all of the testing and documentation that OpenClinica 3.0 is going through will end up generating thousands of pages of “paper” that include user requirements, traceability matrix, and a large set of screenshots which prove the expected results of the test cases did in fact happen.

In addition to the team at Akaza that has invested thousands of hours testing the application, this release has also undergone road testing in our first OpenClinica Pilot Program.  I would like to warmly thank the participants of the program for committing their time and effort in making sure OpenClinica 3.0 is our most well vetted release to date.

Please look for an announcement from me in the coming days of when OpenClinica 3.0 is available for download.

– Paul Galvin, Project Manager

OpenClinica 3.0 at Upcoming Industry Conferences: SoCRA, SCDM

Representatives from Akaza Research will operating an OpenClinica 3.0 exhibit at two upcoming conferences:

  • Society of Clinical Research Associates (SoCRA) Annual Meeting
    September 25-27, Nashville, Tennessee (Booth #9)
  • Society for Clinical Data Management (SCDM) Annual Conference
    October 4-6 in Seattle, Washington (Booth #109)

At these events, instances of OpenClinica 3.0 will be readily available for people to “test drive,” and experts will be on hand to answer questions. If you’re planning on attending let us know by sending us a message!

An Opportunity for Transformational Change in Clinical Trials

Life sciences research is recognized as one of the most technologically advanced, groundbreaking endeavors of modern times. Nevertheless until very recently the preferred technology for executing the most critical, costly stage of the R&D process – clinical trials – has been paper forms. Only in 2008 did adoption of electronic alternatives to paper forms take place in more than half of new trials. This recent uptick in adoption rates is encouraging, but further transformational change in the industry is necessary to fully realize the promise of Electronic Data Capture (EDC) and associated “eClinical” technologies. Two developments that could provide the framework for such change are adoption of open data standards and the use of Open Source Software.

Data standards provide uniform ways to represent information or processes within a specific frame of reference and according to a detailed specification. A standard is “open” when it is not encumbered by patent, cost, or usage restrictions. Open Source Software (OSS) is defined loosely as software that allows programmers to openly read, redistribute, and modify the source code of that software. The combination of OSS and open standards is a proven way to deliver improved flexibility, quality, and efficiency.

A community-driven open source offering that harnesses open standards can produce robust, innovative technology solutions for use in regulated clinical trial environments. Most Open Source Software is built using a collaborative development model. The OSS development and licensing model encourages experimentation, reduces ‘reinvention of the wheel’, and allows otherwise unaffiliated parties to build on the work of others. The result is that OSS can become a key driver of increased IT efficiency and a way to wring out unnecessary costs. In many cases, users can have the best of all worlds: the ability to adopt software rapidly and at low cost, the flexibility to develop and extend their systems as they choose, and the ability to reduce risk by obtaining paid commercial-grade support.

As clinical research struggles to become more automated and efficient, we need to rely on interoperable systems to meet challenges of flexibility, quality, and speed. The OSS development model also naturally leads to the adoption of well-documented, open standards. Because OSS product designers and developers tend to reuse successful components and models where available, OSS technologies are often leading implementers of standards. For example, the National Cancer Institute’s Cancer Bioinformatics Grid (caBIG) initiative is “designed to further medicine’s potential through an open source network” based on open data standards and infrastructure that support sharing of heterogeneous data. This remarkable effort aims to connect large networks of researchers in ways that enables efficient re-use of data, eliminates duplicate systems, and enables new types of translational research.

In industry-sponsored clinical trials, standards such as the CDISC Operational Data Model (ODM), Clinical Data Acquisition Standards Harmonization (CDASH), and Study Data Tabulation Model (SDTM) have gained adoption in both proprietary and OSS software platforms. In some cases, standards are mandated for regulatory submission and reporting (SDTM, clinicaltrials.gov) and obviously must be adopted. Other cases, such as use of ODM, CDASH, and general web standards such as web services and XForms tend to be adopted to the degree they have a compelling business case.

The business case for standards centers on increasing accuracy and repeatability, enabling reuse of data, and enhancing efficiency by use of a common toolset. A well-designed standard does not inhibit flexibility, but presupposes idiosyncrasies and allows extension to support ‘corner cases’. Leading industry voices share compelling arguments how to use standards such as ODM, CDASH, XForms, and Web Services to achieve these goals. Though the details are complicated, the approach offers orchestration of disparate applications and organization of metadata across multiple systems. There is change control support and a single ‘source of truth’ for each data point or study configuration parameter, so when study designs change (as they inevitably do) or a previously committed data point is rolled back, it is automatically shared and manual updates to systems are not necessary. Because the ODM, CDASH, and SDTM are used as a common “language”, the systems know the meaning and structure of data and can process transactions accordingly. Here’s a tangible example:

Lets imagine an IVR system wanted to check with an EDC system if a subject was current in a study (current meaning not dropped out, early terminated or a screen failure).  A Web Service could be offered by the EDC system to respond with a ‘True’ or ‘False’ to a call ‘IS_SUBJECT_CURRENT’ ?  Of course hand-shaking would need to occur before it hand [sic] for security and so on, but following this, the IVR system would simply need to make the call, provide a unique Subject identifier, and the EDC system web service would respond with either ‘True’ or ‘False.  With Web Services, this can potentially occur in less than a second.

Electronic Data Capture – Technology Blog, September 28, 2008

While this integration requirement could be satisfied by development of point-to-point, proprietary interfaces, this approach is brittle, costly, and does not scale well to support a third or fourth-party system participating in the transaction. It is critical that standards be open so that parties can adopt and implement them independently, and later interface their systems together when the business case calls for it. A leading industry blogger makes the case for the openness of standards within the ODM’s ‘Vendor Extension’ architecture: ”The ODM is an open standard, the spec is available for free and anyone can implement it. This encourages innovation and lowers the barriers to entry and therefore costs. Vendor Extensions are not open, the vendor is under no obligation to share them with the market and the effect is that meta-tools and inter-operability are held back.”

Having the software that implements these standards released as open source code only strengthens its benefits. Proprietary software can implement open standards, however given the proprietary vendor’s business interest to lock-in license revenue, might the vendor be tempted into tweaking or ‘extending’ the standard in a way that is encumbered to lock users into their platform? This strategy of “embrace, extend, extinguish” was made famous in the Microsoft anti-trust case of the 1990s, where it came to light that the company attempted to apply these principles to key Internet networking protocols, HTML and web browser standards, and the Java programming language. They hoped to marginalize competing platforms that did not support their “extended” versions of the standards. Thankfully, they had limited success in this effort, and the Internet has flourished into the open, constantly innovating, non-proprietary network that we know today. The eClinical technology field is at a similar crossroads. By embracing open standards, and working concertedly to provide business value in re-usable OSS technology, we can achieve a transformation in the productivity of our clinical technology investments.

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/.

OpenClinica and Open Source at DIA Annual Meeting

Akaza Research is pleased to announce that Cal Collins will deliver a presentation at the Drug Information Association’s (DIA’s) 45th Annual Meeting, June 21-25, in San Diego, CA. The session, titled “Utilizing and Integrating Open Source Software in Clinical Research Environments,” will explore how open source, standards-based software can improve flexibility, interoperability, and cost in clinical trials. It will take place June 22, 10:30AM – 12:00PM (Pacific Standard Time) in Room 15B.

At the event Akaza Research will also be exhibiting OpenClinica, its flagship open source clinical trials software product for electronic data capture (EDC) and clinical data management. Personnel from Akaza Research will be on-hand to demonstrate OpenClinica and answer questions.

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