Validating Open Source eClinical Systems

Validating software you use in clinical research is a requirement of most regulatory authorities, such as the FDA under 21 CFR Part 11. It’s also generally considered a good practice that ensures a system adequately meets your needs. However, validating software can be a confusing topic to many. Validation WP

In her white paper, “Validating Open Source eClinical Systems” validation expert, Laura Keita, articulates the validation process and responsibilities, and simplifies the principles of validation by focusing on the core mantra: “plan it, do it, prove it.” The paper also looks at validation strategies for open source eclinical software, and how the FDA has acknowledged the impact the open source model has on improved software quality—all part of the spirit of validation.

Introducing OC14: Call for Content

Save the date for the 2014 OpenClinica Global Conference: June 22-23 at the Exchange Conference Center on Boston’s historic waterfront.Image

Planning is well underway. We are pleased to have as our keynote speaker, Dr. Eric Perakslis, Executive Director at the Harvard Center for Biomedical Informatics and former CIO of the U.S. FDA.

Do you want to present at OC14?

Presentation proposals are being accepted now through March 31st.

Spend some quality time learning with the best and brightest in the OpenClinica Community, while meeting new (and old) friends.

Early bird registration is now through May 2nd.

More at www.oc14.org.

– Ben Baumann

Forum upgrades and more

OpenClinica CommunityWhen you join OpenClinica as a user or a developer, you are joining an active, collaborative community. Our community is growing and with that growth it is constantly changing. Very soon you’ll see some changes that will allow you to interact with other community members in a richer, more powerful way.

The venerable GNU Mailman list software has been at the heart of the OpenClinica community for many years. It does it’s intended job (user and developer email lists) really well, but does not offer many features beyond that. Next week we are launching a new tool to power how the community works and corresponds.

The new OpenClinica Forums, powered by Vanilla, will offer the ability to post and read via the web. They still support email-based correspondence, so if you prefer to post and read via e-mail, you won’t notice much of a difference from how you’re used to doing things. In addition, the new web interface will have numerous features for search and collaboration that are simple yet powerful.

The forums will be organized into categories by topic. Some will be end-user focused, some will be IT/system admin focused, and some will be developer focused. Others may be a hybrid. If you’re currently subscribed to either the users or developers list, upon launch of the new forums, you’ll be subscribed to receive email from all of forum categories if you wish. However, you can log in to customize your settings to only receive emails from certain categories. If you have an idea for a new category, suggest it on the forums and if there’s support for it in the community we’ll create it for you.

Like any growing community, having a few ground rules about expected behavior is good for everyone. The OpenClinica community already does a great job being respectful and helpful, but it’s good to put the basics in writing so new and old participants alike know what to expect. New Community Guidelines (to be posted next week as well) are designed to help preserve the valuable culture our community has established, and ensure that participants continue to engage in the same meaningful, respectful ways as we grow. The guidelines are modeled off other successful open source communities and should be intuitive to most… however if you have feedback that can improve them, let us know (on the forums of course)!

Last and perhaps most exciting, we’ll soon be launching a new OpenClinica Extensions site. This site will allow you to easily share useful tools, add-ons, and integrations you have built to make OpenClinica more useful. It will be a catalog of useful OpenClinica resources from around the globe. We’ll have more information in the coming weeks as this gets closer to launch.

OpenClinica Central User Training – Feb 24-27 – Waltham, MA

Don’t miss OpenClinica’s Central User training course in Waltham, MA, February 24-27!

Register now, seats are filling up!

Register for Training

About the course:

Our most popular course, OpenClinica “Central User” Training delivers a 4-day intensive experience for people who need to learn about using OpenClinica from all types of user perspectives. This course is ideal for someone who wants to become an OpenClinica super user or will be responsible for training/teaching/supporting their colleagues. Classes are highly interactive and incorporate exercises and tailored instruction. We also regularly organize private classes as needed.

Register at:

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

We hope to see you in Waltham!

Warm Regards,
The OpenClinica Team

EDC Scandinavia uses OpenClinica for BYOD ePRO

Krister Kristianson, PhD.
EDC Scandinavia AB, Stockholm

RESTful web services with OpenClinicaIn a recent study involving several hundreds patients, we decided to offer patients the ability to collect their diary data using their own smart phones instead of the traditional paper diary. The patients who decided to participate in the study downloaded the app to their smart phone or could use their desktop to access the application.

The apps were developed for iPhones and Androids with a reminder function that notified them when to report their symptoms. The data was then transferred to OpenClinica using the RESTful web services immediately upon entry. The patients ID and pin code were tested before data was added to the database to avoid any illegitimate entries.

About 80% of the patients decided to use the electronic diary – 65% using iPhones and 35% using various Android devices. They could also download the app to iPads or other tablets and if they preferred, they could use the application on desktops.

Outcomes:

  • Paper CRFsOf the patients who used the traditional method of reporting diary data on paper, 2.5 times more patients failed to report at scheduled time points compared to the patients using the app.
  • The app recorded the date and time automatically. When using paper, you can never be sure that the diary has not been completed at the time listed.
  • The addition of simple edit checks mitigated data entry errors, greatly contributing to the increased quality of the data.
  • It further reduced the manpower needed to manually enter data on to the eCRF and enabled us to monitor the patients in real-time and contact them if anything went wrong.

Although the patient population was relatively young, in this part of the world, even elderly patients are likely to use smart phones or desktops and would to be willing to use electronic data capture (EDC) for reporting diary data. The easy configuration of web services in OpenClinica and the ability to query data upon arrival made it an easy task to set up and validate the study.

OpenClinica at Netherlands CTMM Annual Event

ctmm_AnnualmeetingOn September 12, 2013, The Center for Translational Molecular Medicine (CTMM) held their annual meeting at the Media Plaza, Jaarbeurs Utrecht in the Netherlands. The theme,  ‘Let’s talk about Value,’ celebrated the implementation of proven results in a clinical practice, the benefits they will bring for patients, and the real value they will add to society and the Dutch economy. The presentations covered all the angles from basic research to implementation in today’s healthcare environment, giving you a unique perspective on end-to-end translational research and its societal and economic impact.

CTMM’s Translational Research IT (TraIT) group, an OpenClinica partner, held a presentation entitled, tranSMART, the TraIT road towards data integration and sustainability. Kees van Bochove (The Hyve) and Remond Fijneman (VUmc) discussed the phenomenal size of the datasets produced in research programs and their distribution over different research laboratories and clinics. These require an informatics infrastructure that allows for a seamless integration and exchange of large amounts of data as well as for complex data analysis. They also discussed the use of OpenClinica’s EDC | CDMS system and how it has enabled the aggregation of much of the data  and the extensibility, through web services, to handle all the unique areas of medicine supported by CTMM.

Back from the OpenClinica German Users Group Meeting

Loebe_900Last month, OpenClinica users throughout Germany converged in Berlin for the very first German OpenClinica Users Group Workshop entitled: OpenClinica – an Open-Source Clinical Data Management System for Clinical and Translational Research. This was held at the TMF (Technology, Methods, and Infrastructure for Networked Medical Research) facility.

Brought about by the efforts of Matthias Löbe, the goals of the workshop were to gain experience, insight, and give back to the strong community of OpenClinica users in Germany. Löbe offered the following insight when asked about his motivations for organizing this group:

“It turns out that there are many locations throughout Germany with OpenClinica experience along with many developing adaptations or extensions. But so far, none of the 70 registered workshop participants knew of the activities carried out by others. The workshop has opened a whole new perspective.”

Goodwin_900My colleague, Alicia Goodwin, who has been working with OpenClinica since 2007, was invited to speak at the conference. I interviewed Alicia after she returned to share insight on the event. 

What were you looking forward to the most at the workshop?
I really wanted to meet the OpenClinica users and learn about how OpenClinica is used in Germany. The workshop had about 70 participants, representing seasoned users and developers to clinical site personnel looking for more information. There are several very active and brilliant OpenClinica community members in Germany, such as Mattias, Gerben Rienk, Philipp Leusmann, Henrik Dittman, Christian Hänsel, to name just a few. I was excited to hear about the wide range of work they are involved with.

Was the entire workshop spoken in German?
Yes, it was. Thankfully, I have enough of the language experience that I was able to understand most of what was being said.

You were invited to speak at the workshop. What was your talk about?
I spoke about the vital users and developers in our community and their role in OpenClinica development, innovation, and global support. I also talked about some of the development tools that are used. JIRA was a big topic as it really underscores our commitment to transparency, our rigorous SDLC, and our open source ecosystem.

What kind of technical information or issues were discussed?
A key theme was around the value that could be obtained from increasing portability and scalability extending th RESTFUL APIs and reusing study elements such as OIDs, rules, metadata across multiple systems. Essentially, looking at architecture in the future.

Was there anything that surprised you at the workshop?
One of the really cool things that I saw was a project called OpenClinica Big Data, developed by Dr. Thomas Deserno from Aachen University. OpenClinica Big Data is an OpenClinica extension specifically designed to handle some of the unique challenges associated with uploading and managing large image file sets. The system utilizes OpenClinica web services, allowing users to make calls from OpenClinica to retrieve image data from the Big Data repository. This module enriches OpenClinica with a convenient and context-related transfer of binary large objects (blobs), such as biomedical images or signals.

I was also very impressed with the overall enthusiasm and turn-out. Hopefully this initial workshop will encourage ongoing interaction among German-speaking OpenClinica users.

© TMF – Images property of TMF

Calling all OpenClinica Users – 2013 Usage Survey

We need your help! To effectively gather information on the worldwide use of the OpenClinica software platform, your input is crucial. Please take this very short survey and we will donate $2, on your behalf, to the St. Jude Children’s Research Hospital. We will share the level of support for St. Jude’s after we wrap up.

TakeSurvey

Thank you for representing the growing OpenClinica community and for your part in making the world a healthier place.
» Rob

OpenClinica Central User Training – Brussels – October 15-18

Don’t miss OpenClinica’s Central User training course in Brussels, from October 15 – 18!

Register now, seats are filling up!

Register for Training

About the course:

Our most popular course, OpenClinica “Central User” Training delivers a 4-day intensive experience for people who need to learn about using OpenClinica from all types of user perspectives. This course is ideal for someone who wants to become an OpenClinica super user or will be responsible for training/teaching/supporting their colleagues. Classes are highly interactive and incorporate exercises and tailored instruction. We also regularly organize private classes as needed.

Register at:

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

We hope to see you in Belgium!

Warm Regards,
The OpenClinica Team

OpenClinica and TraIT: A Dutch National Research Infrastructure

Is it possible to set up an IT infrastructure for translational research for an entire country? The Dutch Translational Research IT (TraIT) project (http://www.ctmm-trait.nl/) believes it is. Admittedly, The Netherlands is not exactly the same size as China or the US, but nevertheless already 26 partners from industry and academia to collaborate in this consortium to organize, deploy, and manage a nationwide IT infrastructure for data and workflow management targeted specifically at the needs of translational research. It includes the Dutch university medical centers, notable companies like Philips, and charities such as Dutch heart and cancer foundations.

At its outset, TraIT worked closely with selected translational research projects and scientists, piloting potential solutions with real research data from these projects. This work resulted in the selection and implementation of central TraIT services for clinical data gathering (OpenClinica) and image archival and retrieval (NBIA). TraIT has now reached a very interesting phase where the first IT solutions put in place in each of the four major domains of translational research (clinical, imaging, biobanking and experimental (any-omics)) are starting to flourish.

Word is quickly spreading about the TraIT infrastructure available. In particular, OpenClinica is taking off very well with amazingly little advertisement: currently the TraIT installation (OpenClinica.nl) contains 47 studies with 256 users representing 77 institutions, and is still growing rapidly as can be seen in the following graph:

Uptake of OpenClinica in TraIT

Based on the input obtained from users, we decided to augment some of OpenClinica’s capabilities, in particular for data loading. Obviously, the improvements are made available to the community whenever possible. For further enhancements, TraIT and OpenClinica, LLC entered into a partnership focusing (initially) on improvements in the areas of role-based security, linking to external (imaging) data archives, and data import/export. Hopefully, the fruits of this collaboration will soon be available to the entire OpenClinica community.

The next challenge faced by the TraIT project is integrating the clinical data from OpenClinica with molecular profiling data, which is needed to address the key question in translational research: how to correlate the variation in disease phenotype to variations in underlying biology. Another open source solution has been selected for this purpose: tranSMART, a translational workbench and data integration environment supported by several major Pharma and research consortia. The open source tools selected promise to be a powerful combination: data collected in OpenClinica can be further shared and analyzed in the tranSMART environment.

View slides from a presentation on TraIT delivered at the 2013 OpenClinica Global Conference.

Jan-Willem Boiten
Project Manager
TraIT at the Center for Translational Molecular Medicine (CTMM)