OC18 details announced. Register today!

We’re excited to open up registration for our 10th Annual User Conference. Prepare to get personal (in terms of data, anyways) for two learning-packed days at Le Meridien Cambridge-MIT. Together with our community of users, we are building a program bursting with the timely, real-world topics and case studies you’ve come to expect from our Annual Conference. Topics will include:

  • Data security
  • GDPR and Compliance
  • How to Conduct an Audit
  • Ultra-capable forms
  • Randomization
  • eConsent
  • Data visualization and reporting with OpenClinica Insight

On the second night, join your peers for an evening of elegance and education at the nearby Museum of Science. Super User training will be offered on October 17, 18, and 19 right in Cambridge.

Learn more and register here.

How Good Are We at What Matters?

For the last several months, we’ve asked professionals with data management responsibilities to evaluate their current processes for accomplishing critical tasks. We then asked them to rank three of these tasks as their first, second, and third priorities.

We asked respondents to evaluate their current processes

Respondents rank their EDC task priorities

Specifically, we each respondent to consider these EDC-related tasks…

  • Getting your eCRFs to look and act the way they should
  • Producing reports
  • Building and publishing studies on your eclinical platform
  • Keeping the number of queries at a reasonable level
  • Tracking source data verification
  • Getting timely data from study participants (diaries, questionaires, etc.)
  • Coding adverse events and conmeds
  • Integrating with other eClinical systems
  • Demonstrating compliance for regulatory and security purposes
  • Implementing protocol amendments
  • Getting data into SDTM
  • Creating and managing accounts for users and sites
  • Getting approval and sign-off from stakeholders on study design
  • Working with your system’s support team

… and to characterize their process for each one as either…

  • Ideal, or close to it
  • Very good
  • Tolerable for now
  • In desperate need of replacement
  • Not applicable (i.e. not part of my duties)

The data below reflects the responses of data managers (n=25), study and program leads ( n=13), IT/database professionals (n=6), and a CRA. To reduce bias, we did not include responses of known OpenClinica users.

What did we learn? Data managers and their colleagues are getting the job done (no surprise there) and are generally content with the way they’re doing it. But current processes usually fall short of ideal. How do your experiences compare?

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Getting eCRFs to look and act the way they should

Producing reports

Building and publishing studies

Keeping the number of queries at a reasonable level

Tracking source data verification

Getting timely data from study participants (diaries, questionaires, etc.)

Coding adverse events and conmeds

Integrating with other eClinical systems

Demonstrating compliance for regulatory and security purposes

Implementing protocol amendments

Getting data into SDTM

Creating and managing accounts for users and sites

Getting approval and sign-off from stakeholders on study design

Working with your system’s support team

Data Gets Personal at OC18, October 15 and 16 in Boston, MA

OC18 data gets personal logo boston skyline

“Can we get personal?”

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! 

 

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More than Checking Boxes: An eConsent Q&A [audio]

eConsent; tablet; mobile device; clinical research consentFor 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.

 

Brittany on eConsent

Download the mp3

 

Transcript

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?

Sure.

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

Moderator:

Cal Collins CEO, OpenClinica

Panelists:

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

Session overview:

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.

Learning objectives:

  1. Translate the requirements of informed consent in its usual, paper-based context to one where documentation is electronic
  2. 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

Optimized AE management, “any file” uploads, and more in this week’s OC4 release

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. 

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Study designers can even select key fields in the forms to display those field values on the (new, UX-optimized) Subject Details page, allowing users to view form data without having to open the form.

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“Upload a file, any file”

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:

  • First name
  • Last name
  • Username
  • Email address
  • 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.


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Have will you leverage these capabilities? Let us know with a comment.

Intelligent, visual reporting is here!

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.

Learn more about Insight now, or schedule a time to speak with our team. We hope you can join us in March.

Join our OC4 Webinar on Monday, January 22

Happy New Year!

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.

Click here to register!


 

 

OC17 is just 32 days away! Here’s the detailed program.

If you’ve been waiting for more detailed session information to register, wait no more. You’ll find all the session and workshop abstracts, with speaker bios, on our OC17 resource page.

See the OC17 session abstracts

OC17 is also your chance to see the new OpenClinica up close. Take a “deep dive” into the all-new study build system and form engine.


See more of the new OpenClinica

 

Do not hesitate to email bfarrow@openclinica.com with any questions regarding OC17.