Free Webinar, Aug 27: Successful Part 11 Compliance in a Universe of Electronic Data

Regulatory compliance may not always be the life of the party, but understanding its basics and being prepared for some of its hoops is becoming increasingly important. With that in mind you may find this upcoming webinar on successful compliance quite helpful if you’re new to 21 CFR Part 11 or if you’re looking to learn what’s new in the clinical research data landscape.

Hosted by our friends at Bio-Optronics and presented by OpenClinica CEO Cal Collins (@CalCollins1) the webinar will:

  • Review the basics of 21 CFR Part 11 and related regulations.
  • Examine what data and systems are within the scope of Part 11 and which are tangential.
  • Discuss how both good tools and good processes are necessary to succeed in a Part 11-compliant environment.
  • Briefly explore the changing landscape of electronic data in healthcare, and what it means for research.

The webinar will feature a 45-minute presentation and 15 minutes of Q&A, so make sure to send your questions or tune in for additional compliance intel.

Update: This webinar is now available for download.

Successful Part 11 Compliance in a Universe of Electronic Data

Presenter: Cal Collins, CEO OpenClinica
Wednesday,  Aug 27, 2014
3:00 PM – 4:00 PM EDT

Webinar hosted by:

clinical_conductor

Automatic Event Scheduling with OpenClinica 3.3

An exciting new feature that has been at the top of the request list is Event Scheduling. Using the flexible and powerful Rules Designer in version 3.3, you can now build rules to automatically schedule events.

There are several workflow methods which offer a customized way of handling your study calendar.

Method 1 – Manual Reschedule

In Method 1, a series of study events can be scheduled at once off a given event date.  Any subsequent changes to event dates will not be automatically rescheduled. You can use arithmetic to generate future event dates (e.g. Visit 2 date = Visit 1 + 7).  OpenClinica also supports use of static dates and the system’s “current date” variable.

MethodOne

Method 2 – Auto Reschedule

In Method 2, a given event date generates all future visits and any changes to an event date in the chain will automatically update subsequent event dates.

MethodTwo

Method 3 – Auto Reschedule Based on Event Status

OpenClinica also allows you to write EventAction rules using the event STATUS. This opens the door to more calendaring power! Here, you can schedule an Event based on the status of another Event. For example, if a critical visit is skipped the system can auto-schedule the End of Study visit. Or let’s say you only want the next event to be scheduled when the current event is “Completed” (or “Started”). This is all possible–it’s really up to you.

MethodThree

Rule Designer Example

See the following example of scheduling the next event with Rule Designer.

EventActions_Rules

If you haven’t heard, the OpenClinica Rule Designer is now freely available. See http://wp.me/p6ydw-rE for more details.
Learn more about Event Scheduling with Rule Designer HERE.

Using Tokens in OpenClinica CRFs and URLs

An important new feature in OpenClinica 3.3 is the ability to incorporate variables in your CRF display. When designing your CRF, you can embed tokens into your form design with some simple markup (such as ${studySubject} to print the Study Subject ID). When the CRF is rendered for a patient visit, the tokens are parsed and replaced with the appropriate values. So, if you now want to display the name of the study, visit name or number, or study subject ID on a particular place on the form, you merely need to insert the token in the right place. You can even display the value of an item – for instance if you want to display a value entered in section 1 on a later section of the form, just use ${item[‘item_name’]}, replacing item_name with the name of your item. (screenshot right-justified – overlay snippet of CRF w/token on top of snippet of LI text with parsed variable)

ParameterizedLink2

This feature can be used in much more powerful ways too, especially when combined with the existing ability to include HTML markup and javascript code in your CRF.

In addition, tokens can be embedded as parameters in a link to an external system, such as an imaging or genomic data store. With the use of parameters specific to the study subject and event CRF, the link can take the user directly to the relevant record in the external system. With a little bit of clever javascript, the form could even embed the image or other media directly. You’ll have to set up appropriate security rules in the external system to allow this, and ensure the two systems share the same identifiers. (screenshot of embedded image)

The design, coding, and testing of this feature has been developed in collaboration with our fantastic partners at CTMM/TraIT in the Netherlands. With them, we have been able to build a feature that will fulfill a key need of theirs (link directly to a patient image at point of data entry). With the feedback of others in the community we’ve been able to make it generalizable for a far broader set of capabilities, adding to OpenClinica’s powerful existing API and extensibility while keeping it simple and familiar.

Read more here.

OC Innovation Award & Community Catalyst Award Announced

A big thanks to all the folks who helped make OC14 on June 22 & 23 a smashing success! We had engaging workshops on Sunday and a developer meet-up co-facilitated by @albertk and @kkrikor. Monday delivered a fantastic line-up sessions and demos which highlighted a lot of the exciting innovation that’s taking place in the OpenClinica community. To give you a glimpse of these sessions, we will post the session slides online soon.

At the end of the day on Monday, Cal Collins presented two newly created awards recognizing individual contributors to both our community and our software. These awards were determined based on the community’s feedback and nominations. Huge thanks and appreciation goes out to these gentlemen for their great work and selfless contributions to the community.

Congratulations to Gerben and Lindsay—this recognition is well deserved!

And special thanks to numerous others who have have done amazing work with OpenClinica. Here’s to ongoing community collaboration that will continue to deliver innovations that will make OpenClinica even more of a uniquely impactful tool for clinical research.

OC14_199Some of the attendees at OC14 at the Exchange Conference Center in Boston.

New: OpenClinica Extensions Site

OpenClinica_Extensions

ExtensionsA number of people in the OpenClinica community have extended the OpenClinica platform in many useful ways—adding new features, building translations, CRFs, and other productivity enhancing tools. Sharing these extensions with others in the community can help make them the best they can be, by giving them greater adoption, generating useful feedback, and attracting additional collaborators.

In an attempt to make it easier to develop, share, and use these works, we have created the OpenClinica Extensions Site—a central place for people to make their project visible to others, while facilitating adoption and collaboration. The Extensions Site currently lists a number OpenClinica Extensions and we look forward to more new projects as they are added.

– Krikor Krumlian

OpenClinica Rule Designer Now Open Source

I’m excited to announce that the OpenClinica Rule Designer module is now freely available to all OpenClinica Community Edition users, and the source code is open to developers.

With this tool, users can more easily create powerful and advanced rules, driving productivity. With the upcoming release of rules-based event scheduling it is a great time to open up this valuable, time-tested tool. You can request access to the hosted Rule Designer for your Community Edition instance here.

Up until now, the Rule Designer has been available only to users of the OpenClinica Enterprise Edition. We are always looking to reduce hurdles to increasing the adoption, development, and innovation of OpenClinica, and being more open is almost always the best way to do this. Making the Rule Designer open source and freely available encourages feedback and contributions that make it better for everyone, and enables innovative re-use of parts of the code.

If you are an Enterprise Edition subscriber, nothing will change, and you’ll continue to have fully supported access to your Rule Designer backed by our Service Level Agreement.

OpenClinica is already a highly successful community project. Tens of thousands of community members use the technology and many share their innovations, create extensions, write documentation, help beginners, translate, and contribute code to the core software. Now developers interested in advanced study design capabilities can join the party, too!

Here are a few parts of the Rule Designer code that are worthy of note:

– Tree model of an OpenClinica study with 3 views – by CRF, by CRF Version, by Event Definition
– Drag-and-drop rule design functionality
– Use of the REST API to interact with OpenClinica core
– Use of OAuth to authenticate with OpenClinica to use the REST API

Get the source code on GitHub (LGPL license). Technical information on how Rule Designer works and interacts with OpenClinica is here.

There will be some great information about the Rule Designer and the new calendaring features at the upcoming OC14 conference. Long time OpenClinica expert Alicia Goodwin will facilitate a workshop on “Rules for Advanced Users,” providing a deep dive into OpenClinica Rules, a powerful mechanism for adding workflow, edit checks, and other capabilities to your OpenClinica study. She will also be showing the latest innovation of Rules-based calendaring features. More here.

OC14Logo250x260

A Look at the 2014 OpenClinica Conference Program – An Ecosystem of Innovation

The program for OC14 (the 2014 OpenClinica Global Conference) has been posted–what a line-up! Having been involved in each of the past 5 OC conferences, I can say that this one has a lot new and useful things to offer.  Many in the OpenClinica community are not aware of all the useful innovations produced by our community scattered throughout the globe. The theme of the conference is “An Ecosystem of Innovation,” and OC14 will help to communicate a number of the innovations available to you and show you how you can take advantage of them for your own work.

OC14 is a unique opportunity to enhance your capabilities and skills with OpenClinica in an information-packed 2 days, June 22-23 in Boston. Early bird deadline registration is May 2nd.

Here are some of the things you can do at OC14:

Interactive demonstrations:

  • OpenClinica Monitoring Platform
  • Converting OpenClinica Datasets to SDTM
  • DynaOCreports: A web-based reporting tool for OpenClinica
  • Medical Coding for OpenClinica EDC
  • OpenClinica-CTMS Integration with Clinical Conductor
  • New Features Playground
  • OpenClinica ePRO Mobile & OpenClinica ePRO Web
  • A Tour of Developer Resources
  • elluminate: Aggregate and Standardize Your Clinical Data
  • OpenClinica Enterprise Edition
  • Randomization in OpenClinica with RANDI2

Informative sessions, featuring innovative OC extensions, case studies, best practices, and more:

  • Lessons Learned from Integrating OpenClinica with Other IT Systems
  • Using OpenClinica for Risk-Based Monitoring and Monitoring Reports
  • Developer Meet-Up Report
  • Data Preparation, Delivery and Analysis: The Emerging Value of CDISC Data Standards in the New Era of Data Transparency
  • OpenClinica Extensions: From Nano to Macro
  • Importing Lab Normal Values: A Case Study
  • Risk-Based Monitoring with OpenClinica, add-ons and REST
  • con•nec•tiv•i•ty: Using Open Source APIs to Redefine the eClinical Ecosystem
  • OpenClinica in an Integrated Translational Environment
  • Maximizing your OpenClinica ROI with Community Engagement
  • EDC Methods in Studies Conducted in Western Kenya
  • Simplifying ODM with JSON
  • Expanding OC the Ecosystem

Workshops (in-depth, hands-on instruction in focused areas):

  • Rules for Advanced Users (includes new Rules-based calendaring features)
  • Best Practices for Building Studies
  • Meeting GCP and 21 CFR Part 11 Requirements with OpenClinica
  • Internationalizing OpenClinica
  • IT Primer for Setting-up and Running OpenClinica

In addition to the above, you can:

  • Connect with the developer community at a special OpenClinica Developers Meet-up.
  • Roll up your sleeves, relax, and enjoy the summer sun at a classic New England clam bake.
  • Get certified with 4-day OpenClinica Central User Training course while you are in Boston.

Here is the full program. Looking forward to seeing you in June!

– Ben

The Future of Open Source

It was a privilege for OpenClinica to help with the “Future of Open Source” survey recently completed by Michael Skok of North Bridge Ventures, Black Duck and Forrester. The survey polled users and other stakeholders across the entire spectrum of OSS.

Recently published results from the survey substantiate the idea that open source is ‘eating the software world’s lunch’ (to borrow a phrase from Michael). OSS powers innovation, increases security, and enables a virtuous cycle of proliferation and participation across major sectors of our economy. This is even true in healthcare and life sciences, and we are seeing these trends within OpenClinica community. People are adopting OpenClinica and other open source research technologies because of the quality, flexibility, and security they provide, not just to save a buck or two.

What I find particularly significant in the results is the increased recognition of quality as a key driver of adopting open source. 8 out of 10 survey respondents indicate quality as a factor for increased OSS adoption. This has vaulted from the #5 factor in the 2011 survey to #1. In research, quality and integrity of data are paramount. OpenClinica’s active (and vocal!) community’s constant scrutiny of the code, and continuous improvements demonstrate the power of the open source model in producing quality software. Furthermore, working in a regulated environment means you need to do more than just have quality technology. You also must provide documented evidence of its quality and know how to implement it reliably. The transparent development practices of open source are huge contributors to achieving the quality and reliability that clinical trials platforms require. Knowing that feature requests and bug reports are all publicly reported, tracked, and commentable means nothing can hide under the rug. A public source code respository provides a history of all changes to a piece of code. And of course, it greatly helps that many of the key tools and infrastructure that power open source projects are open source themselves.

That’s just one set of factors driving us to a more open, participatory future:

“As a result of all this, Open Source is enjoying a grassroots-led proliferation that starts with a growing number of new developers and extends through the vendors and enterprises to the applications and services, industries and verticals, reaching more people and things in our everyday lives than ever before… there are now over 1 million open source projects with over 100 billion lines of code and 10 million people contributing.”

One thing I predict we’ll see a lot more of in the next year, especially for OpenClinica and life sciences as a whole, is greater interaction between projects and communities. OSS reduces traditional barriers and lets more people ‘get their hands dirty’ with tools and technologies. As OSS tools, libraries, and apps proliferate, innovation will increasingly come from the mashups of these projects.

Follow the survey findings and updates @FutureofOSS and #FutureOSS  

Responding to Heartbleed

Please change your OpenClinica passwords.

By now you’ve probably heard about the Heartbleed web security bug. At OpenClinica we take the security and integrity of our users’ data very seriously. We have been hard at work over the past 3 days responding to this vulnerability.

Our team worked into the wee hours the past two nights to respond to the problem, and I’m proud to say we have fully patched the vulnerability for all our OpenClinica Enterprise Optimized Hosting customers. If you run an OpenClinica Community instance, please check and patch your system as soon as possible. The vulnerability is at the certificate/server level, so there’s no new version of OpenClinica to install. The exact steps to update will depend on the environment you’re running on. We’ll provide some more information and references shortly. Here’s what you can do:

  • Check your site for vulnerability, using a checker such as https://lastpass.com/heartbleed/.
  • Update your server to current OS patch levels, including applying OpenSSL updates where applicable.
  • Generate a new key and SSL certificate for your domain, and deploy the new key and certificate to the server.
  • Check again via https://lastpass.com/heartbleed/ to confirm vulnerability is patched.
  • Have all users update their passwords.

 

6 Days Left to Contribute to OC14!

That’s right–there are only 6 days left to submit proposals for participation in the 2014 OpenClinica Conference, June 22-23 in Boston. This is a unique opportunity to present at the premier OpenClinica event headlined by luminary Dr. Eric Perakslis, Executive Director of the Harvard Center for Biomedical Informatics and former Chief Information Officer at the U.S. FDA. Share your knowledge and experience, learn from others, and build valuable relationships.

Here are 4 ways to participate:

  • Presenting a session at OC14 is a great way to share your OpenClinica work and experience. Format can be lecture, panel discussion, or other creative idea.
  • Showing a demo can be a great way to get show your OpenClinica related technology in a hands-on way while obtaining direct feedback
  • Leading a workshop gives you a chance to take a deep dive into subject matter you have mastered.
  • Or, join as an attendee to soak it all in!

Learn more and submit your proposal at www.oc14.org. Deadline for submissions is March 31st.