More and more often, that’s the question motivating today’s most innovative research. Whether it’s an RCT with a biomarker cohort or an observational study based on real-world evidence, we’re seeing the “data funnel” widen to encompass much more about the participant than their diagnosis. Genomic medicine is just one example. Factors including phenotypical traits, diet, and lifestyle, among others, are all counting for more in studies that seek to match the right therapy with the right patient.
This year’s theme is a recognition of this important new paradigm. But it’s not meant to constrain. How are you adapting to the complexity of new and expanding data types? How do we make the tools of data management as personal and precise as the results we’re seeking?
We’ll explore these questions and more as data gets personal at OC18!
For the second year in a row, we’re looking forward to hosting a panel session at the Society for Clinical Data Management Annual Conference. Last year, we gathered four experts, including our own Ben Baumann, for a panel on ePRO. This year, we’ll turn our sights on eConsent. Our panelists represent a “who’s who” of seasoned professionals in this area. Learn who they are and read all about the issues they’ll discuss below. First, take a listen as one panelist, project manager and clinical trial educator Brittany Stark, walks us through the advantages of adopting eConsent and tells us why review boards are likely to embrace it as trial complexity grows.
Hello and welcome from OpenClinica. My name is Bryan Farrow and I’m joined today by my colleague, project manager Brittany Stark. Brittany, may I ask you a few questions about e-consent, the topic of our panel at this year’s SCDM conference?
Let’s start by having you tell us about your clinical research career, especially as it pertains to consent.
Working in the professional services department here in OpenClinica, we get a variety of projects invlving eConsent. Prior to joining OpenClinica, I worked at Beth Israel Deaconess Medical Center in their Cancer Clinical Trials Office, where I worked as a clinical research coordinator, later in the regulatory affairs department, and then as a clinical trial staff educator, all involving different aspects of either the education of informed consent documentation of collection.
Great, thank you. For the sake of brevity, I’ll assume our audience is familiar with the basics of econsent and steer our conversation toward the advantages and obstacles associated with it. Let’s start with the obstacles. A common one is the anticipated resistance of review boards. Brittany, why might an IRB resist econsent?
Well they’re used to paper-based methods with an established precedent.
Fair enough, but why should they consider embracing eConsent?
eConsent has the potential to enhance patient understanding by means of an eLearning experience that is engaging and informative. This can be achieved through the use of graphics, interactive tutorials, videos, or even quizzes tapping into their understanding of the study.
An eConsent form can guide a patient through this experience, step by step, only presenting a signature box at the end of these exercises. Paper-based methods, on the other hand, can allow for corners to be cut.
All that sounds terrific. So why are sponsors sometimes reluctant to adopt econsent?
Here again, there’s the weight of tradition. They may also anticipant resistance from local IRBs, which in their eyes could cause delays.
Those are legitimate concerns. What might you say to a sponsor to persuade them to take another look at eConsent?
Sponsor’s shouldn’t assume that an IRB will reject this method. Simply put, an IRB’s priority is patient safety. Patient safety starts with their understanding of the trial and all of the inherent risks involved. As I mentioned before, this is where eConsent can offer more protection through a step-by-step online experience.
Sponsors can achieve tremendous time and cost savings. eConsent eliminates the costs involved in chasing that paper trail, reducing the research team’s time involved in the consent process.
eConsent can also provide real time recruitment rates to study sponsors. This is very important when studies cannot risk going over set enrollment goals. Sponsors can also more accurately project future recruitment with this kind of real time reporting.
Based on everything you said, do you think the future of eConsent looks bright?
Absolutely, and I look forward to talking about this more during our panel.
About the Panel
“More Than Checking Boxes: Integrating Electronic Informed Consent in a Compliant and Ethical Way”
a panel session as part of the 2018 SCDM Annual Conference
Tuesday, September 25, 2017 from 11:15am to 12:15pm
Hyatt Regency Bellevue, Seattle
Cal Collins CEO, OpenClinica
John Wilbanks, Sage Bionetworks
Kristen Warren, DxTerity
Kevin Johnson, Intermountain Heart Institute
Brittany Stark, OpenClinica
Vincent Miller, Duke Clinical Research Institute
Sandra Sather, CRF Health
Regulatory authorities have been clear that Informed Consent is a multifaceted process that goes far beyond obtaining a signature. Genuine consent involves providing potential participants with adequate information about the research to allow for an informed decision to participate, facilitating and verifying comprehension of the information, and allowing adequate opportunity for questions and consideration. The process often continues after enrollment. Investigators are frequently obligated to provide additional information to participants as the research progresses, and even obtained informed re-consent.
Electronic informed consent (e-Consent) must accommodate all these requirements. Done well, e-Consent can maximize patient understanding, engage non-English speakers with multilingual tools, improve documentation and reporting, and standardize the consent process across sites, all while reducing cost and administrative burden. Attendees of this session will learn how to determine the suitability of e-Consent in light of a study’s setting, participant profile, and indication (among other attributes), as well as the best way to adapt the principles of fully informed consent in its usual, paper-based context to one where the process is electronic.
Translate the requirements of informed consent in its usual, paper-based context to one where documentation is electronic
Understand which contexts are suitable for electronic informed consent, which are not, and which allow for a hybrid method
3. Leverage interactive forms and media to improve patient understanding and better document their comprehension and consent
4. Accurately project the time and cost-efficiency gained for a study that relies on e-consent
The first major update to OC4 went live early today, with new features that extend your study’s flexibility so much that we wanted to call them out in this post.
“Common Events”: the new, intuitive way to accommodate AEs and conmed changes
Common events are not associated with a visit date, and do not occur at a scheduled time-point. Instead, they are incidental events that often recur, such as adverse events and concomitant medications. This update makes it easy to include common events in your study. You can include multiple forms in a common event, which allows each form to repeat independently within the event.
You now have several distinct widgets for collecting files.
Image, audio, and video widgets allow users to upload these file types, which may then be viewed or played within the browser window.
We have also added a generic file widget for uploads of any type. (However, these files do not support a preview in the browser window.)
Any uploaded file may be downloaded from within the form.
Draw, annotate, or sign
Used judiciously, free text fields can enrich the data collected in a study. So just image what free drawing can do. This latest update supports:
Drawing on a blank canvas, from a palette of 12 colors plus black, with a mouse, finger, or stylus
Annotating an uploaded image with freehand notes or diagrams (from the same color palette, using a mouse, finger, or stylus)
Signing one’s name, in black only, with a mouse, finger, or stylus
The annotate and draw widgets allow the user to undo individually added lines.
Central User Management
A new feature allows administrators to view a directory of all users created for at least one test or production environment in their instance. Each user record indicates:
Organization (e.g. Site 1234)
all roles for all study environments (e.g. EUPHONY Study (Test): Clinical Research Coordinator, PRAXIS Study (Production): Data Entry Person, etc.)
Role type (Admin or User)
Status (Created > Invited > Available/Signed In)
Date and time created
Date and time last updated
Date and time of last login
An edit button allows an administrator to update a user’s first name, last name, phone number, e-mail address, organization, or user type (i.e., attributes that are independent of any one study or environment). A deactivate button removes access for that user to any study environment to which they had been assigned. For deactivated users, a Reactivate button restores all access.
See the video now, join the webinar on March 26 or 28.
You know it better than anyone: clear, on-demand reporting is more than a “nice to have” in our field. It’s essential to conducting research that’s efficient and safe. That’s why we’re launching OpenClinica Insight. Insight makes it easy to ask questions of ALL of your clinical and operational data and visualize answers via interactive reports and dashboards.
Learn more at either of these upcoming webinars:
Monday, March 26, 8pm GMT, or
Wednesday, March 28, 8am GMT
The idea is simple, but the results are powerful: ask your questions, choose your visualizations, then return often for updated, interactive results that link you to all of the underlying data.
We’re excited to start 2018 with our most significant new release in 10 years. We want to give you all the details in one info-packed hour.
On Monday, January 22nd, from 11am to 12pm EST (UCT-5), learn about the smarter way to build and publish studies, create mobile-friendly forms, and manage your data. We’ll also show you the rock solid security, compliance, performance, and reliability that comes with our cloud hosting.
Provides easy, self-service onboarding for all user types
Is built around “Smart paper” eCRFs – richly interactive, mobile-friendly forms that autosave your data yet give you as much control over layout as if you were designing them in Word
Gives you a collaborative, drag-and-drop study build environment with validated design->test->production pathway for your studies and amendments
We couldn’t deliver these enhancements without under the hood changes that are just as significant as what you see in the user interface. So what are some of those changes?
What’s under the Hood?
The new OpenClinica is a multi-tenant cloud platform that embraces open source, automates provisioning, and provides validated traceability, massive scalability, and high-grade security.
By breaking from the monolithic application model and turning to a microservices model built for the cloud, we’re able to deploy more user-friendly, productivity-enhancing features quickly and reliably. A traditional monolithic software application encapsulates all its functionality in a single code base, continues to grow in complexity as it adds new features, and requires deep expertise in the code base to fix or improve even minor things. With the microservices model, each service performs a small set of business functions, and is built around a web services API from the start, making it far easier to configure, integrate, and orchestrate functionality within the platform and with third-party systems.
For those of you familiar with the OpenClinica 3 architecture, a few of the key changes are:
Separation of study build and study runtime functions into discrete systems
The ability for the study build system to publish a study definition (or updates thereof) to test and production environments to simplify validation / training / UAT / re-use
A new model for building forms, based around the powerful and widely used XLSForm standard.
Use of separate database schemas for each study, increasing scalability, portability, performance, and better support of the full study lifecycle
A single-sign-on mechanism across the OpenClinica systems and services, with ability to plug in to third party authentication mechanisms more easily
Together, these changes make OpenClinica easier, more powerful, smarter, and more open.
Our vision is to harness open technology to make research better. The new OpenClinica is fast to adopt, simple to learn, and a joy to use, whether you’re a data manager, CRA, investigator, or study subject. It doesn’t just capture data: it empowers the entire trial team to work fast, with high quality, and to monitor and respond in real time to challenges that arise. It enables the rapid exchange of clinical, laboratory, imaging, and patient-reported data, with the intelligence to take action on it.
Compliance with all pertinent FDA and EMA regulations, including GCP, 21 CFR Part 11, Annex 11, and HIPAA, continues unchanged, as does our SSAE-16 SOCII/ISO certification.
It doesn’t end there, either. The new architecture provides greater scalability, redundancy, and zero downtime; is modular, built for integration and extension; and is able to evolve faster and more flexibly.
For today’s complex clinical research needs, the leverage we get from modern cloud, DevOps, test/build automation, best-of-breed frameworks designed for microservices is enormous. But there are some trade-offs, including the need to manage 10-50 services at a time instead of 3 (database, application server, application) in the old model. Thus, the new OpenClinica is built to be consumed as a native cloud-based solution. This means that it’s not feasible to provide an easily downloadable ‘Community Edition’. Even with a massive amount of effort, packaging all of those services up into a straightforward download/install process that works reliably in a generic set of environments would be hard. Or, as one of our engineers put it, “a nightmare-inducing morass of things-that-could-go-wrong when it’s not used in the context it was specifically designed for.” By highly automating our cloud environment, we are focusing our engineering resources on getting the most secure, fail-safe, fastest, and highest quality user experience possible shipped and available for your research.
For all the added muscle, the new platform retains the heart of OpenClinica. Most of the database schema is the same. Much of the OC3 source code has been adapted to work within the new architecture. As with OpenClinica 3, most (but not all) of it is open source and available on GitHub. OpenClinica was conceived as a commercial open source project–one that has thrived in large part due to the enthusiasm of developers, domain experts, and practitioners who know that collaborative innovation benefits everyone. This ethos continues to guides the OpenClinica LLC team and inform our work.
What’s new in OC4?
Real-time edit checks and skip logic
Easier and more powerful logic for validation, skips, calculations, and inserts
Real-time, field-by-field autosave
Mobile-friendly design and UX suitable for any device
Layout options for every use case
Build studies using a drag-and-drop interface
1-click publish to test/production environment
Preview forms and edit checks
Define study events, append associated forms, and more
Collaborate in real-time with other users while building and testing studies
Easily re-use forms and events
Form and protocol versioning
Data extracts that reflect clearer form versioning
Self-service training embedded into the user interface
Built for performance and scalability
Updates delivered safely, seamlessly, and automatically
A modernized technology infrastructure enabling future enhancements, including:
Better SDV, reporting, coding, configurable permissions, and metrics
Self-service startup to select your plan and immediately provision your instance
Libraries of reusable items, forms, users, and sites
More efficient handling of “reason for change” and cross form-edit checks
More capable and consistent API
How will this affect my existing OC3 studies?
For existing users, we recommend starting new studies on the new OpenClinica cloud while you keep your OC3 installation for studies already underway. Studies you are conducting on OpenClinica 3 will continue to receive the best-in-class support you’ve always known, all the way through to their completion. While major new features and improvements will focus on the new platform only, we have made more than 50 improvements to OC3 in 2017 alone, and will continue to produce maintenance releases as long as existing studies remain in production.We’re not yet able migrate existing study data from OC3 to OC4, given differences in the form definition model. We’re working on it!
Can I use both OC3 and OC4 at the same time?
Yes! We recommend starting new studies on OC4, with one exception: studies requiring double data entry. This feature is not currently supported on OC4.
How will I get trained and request support?
Integrated training, help, documentation, tutorials, and videos are embedded right into the OC4 application. In addition, our stand-alone training modules and dedicated client services team will be available as always to ensure your success.
What do I have to learn?
The new OpenClinica is far more intuitive, and has tutorials and guides embedded in the application. The biggest change between OC3 and OC4 is the form design model. We offer plenty of resources, training, and examples to help you understand the difference. We’ll be releasing a drag-and-drop form designer and enhanced form library capabilities very soon.
What is the cost?
Plans and pricing are the same for OC4 as for OC3, and based on the number of studies you are actively running. To calculate the number of studies, we’ll add together the studies you have on OC4 and OC3.
You will keep your current pricing through the end of your contract. At the end of that term, you may renew at then-current pricing, whether you upgrade to OC4 or not.
Although we stopped offering plans with ‘unlimited’ studies some time ago, some long-standing customers remain on unlimited plans. At the end of their contract, we will assist these customers in selecting a plan that includes ample studies for current and projected projects at a per-study price that remains cost-effective.
We’ve introduced some new plan options whose flexibility and scope we believe will better serve you. Discounts are available for academic institutions and hospitals.
Is OpenClinica still open source?
As with OpenClinica 3, most (but not all) of the new OC is open source and available on GitHub. OpenClinica was conceived as a commercial open source project–one that has thrived in large part due to the enthusiasm of developers, domain experts, and practitioners who know that collaborative innovation benefits everyone.
Key motivators for open sourcing OpenClinica have been, and continue to be, (1) encouraging innovation, (2) maintaining transparency, and (3) enabling researchers. These principles continue to guides us and inform our work. The new model aims to improve the way these goals are met by:
prioritizing integration capabilities of the platform
keeping key parts open
incorporating and contributing significantly to widely used, third party OSS projects, and
providing a cost-effective and quickly deployable solution, thereby avoiding the potential technical hurdles, security pitfalls, and time costs of maintaining self-provisioned instance.
Key motivators for open sourcing OpenClinica
How the new OpenClinica improves the way these goals are met
Prioritizes integration capabilities of the platform
Keeps key parts open and accessible. Contributes significantly to widely used, third party OSS projects. Continues the RSP which facilitates structured, complete audits for users requiring it
Provides an affordable and quickly deployable solution, thereby avoiding the potential technical hurdles, security pitfalls, and time costs of maintaining self-provisioned instance.
In the near future we will offer a low-cost plan, “OC Ready”, that gives you access to the key features of the new OpenClinica, including the new protocol designer, form engine, and more.
How can I contribute to this innovation?
Open source, open APIs, and readily available tutorials empower developers and technical users to push the envelope of what’s possible. We plan on releasing an OpenClinica “toolkit” for building integrations and health research apps that guarantee high-integrity, trustworthy data and rigorous standards of quality. When it’s available, developers of all experience levels will be able to:
Obtain an API key
Download the toolkit/SDK
Consult API docs & tutorials
See an example module
Build a UI or integration module using the toolkit
Share their module
Improve an existing module
The OC4 Toolkit is still under development, so stay tuned!
In the previous post in this series we covered how the new OpenClinica makes study build, change control, and collaboration so much easier. This improved user experience doesn’t end at first patient in. Take a journey through the heart of the new OpenClinica: its incredible form engine.
As you bring research sites and study team personnel into the fold, they’ll be greeted with a friendly invitation and smooth on-boarding.
Integrated walkthroughs help get your study personnel up to speed quickly.
After a new user responds to their email invitation, OpenClinica will direct the user to the appropriate part of the system and offer a brief tutorial of the application. When they’re ready to go deeper, in-depth online training and on-demand assistance are available.
Connections can sometimes disappear, but data should never get lost.
The solution? Auto-save.
Display only what's relevant.
Not every patient is the same. OpenClinica’s powerful skip logic allows you to show or hide questions, groups of questions, or entire form pages based on prior responses, making data entry more efficient and intuitive. Ask only relevant questions to avoid overwhelming your CRCs and Investigators. They’ll thank you with cleaner, more complete data faster.
Real-time edit checks alert the user to out-of-range or otherwise discrepant values.
(And how about those auto-calculations and the value piping?)
Clearer eCRFs mean cleaner data.
The form engine in the new OpenClinica can help your team minimize mistakes with clear, media-rich, mobile-friendly forms.
The world’s not perfect, and sometimes a CRC will need to leave a record in an imperfect state.
We’ll save it as-is and track the follow-up for you with auto-queries.
A picture is worth a thousand data points.
Let your participants submit images directly into the study database. A link right on the ePRO form launches their mobile device camera.