Why you should make better forms your top data management resolution for 2019

Chances are you’ve already set personal goals for the new year. But have you set professional ones? If not, let me suggest the most meaningful data management resolution you can make for 2019.

“I will build better forms.”

Of all the aspects of eClinical, why rally around forms? For us, the answer is simple. Of all the tools in your toolbelt, optimized forms offer you the greatest leverage in capturing clean data promptly.

Just think about it. You don’t have control over the buzz of clinical and research activity at your sites. You don’t have control over source documents. And you can’t personally visit all your sites, train all your CRCs, or SDV all the items in your study.

So how do you bring order to the (mostly) controlled chaos of a clinical study? You encourage prompt entry of accurate data with forms that are smart, standardized, and, yes, even appealing. Think about what capable forms deliver at the point of entry and downstream:

  • Timely data entry from CRCs who are thrilled to use your beautiful eCRFs
  • More accurate data, thanks to specific, real-time edit check messages
  • Less missing data, thanks to sensible skip logic and clear instructions
  • Reduced SDV burden, as more and more of your clean, flexible forms become the source
  • Reduced time to database lock
  • Easier analysis, thanks to sophisticated “in form” scoring and calculations
  • Smoother submission, with CDISC-standardized exports

Don’t get us wrong. Tools that expedite study design and user management, fast and reliable system performance, rock-solid security – these are crucial too. But forms are where you, your CRCs, and your data live, day in and day out. So in terms of overall study success, the “ROI” on perfecting your forms is hard to beat.  

That’s why we’ll never take our eyes off this so-called fundamental. In fact, we devoted the last few months of 2018 to assembling the best thinking on forms. Not just our thinking, but yours, and that of experts. You can see what we’ve been up to by reading our blog series on cross-form logic or streaming our two December webinars. And we hope you’ll let us know what (in addition to better forms, of course) will change the clinical research landscape this year. Take the poll below!

 

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Which of the following will make the biggest impact on clinical data in 2019?

Deep learning/AI
Risk-based monitoring
Enhanced security (e.g. blockchain… or quantum!)
eSource
Wearables

Master form design with these two on-demand webinars

Equipped with the right system, data managers today have more tools than ever before to capture high-quality right at its source. But what can the “right system” do? And how should data managers deploy those capabilities to prompt accurate, efficient entry from site staff and participants?

We hosted two webinars this month to answer those questions. Now you can watch them on demand. In Kitchen Sink, you’ll spend an economical 30 minutes understanding how OpenClinica’s form capabilities – from cross-form intelligence to modern, multi-media question types – all work together to serve as the user’s partner in capturing better data, faster. In Good Form, we step back to understand the proper role of these capabilities (not all scales are Likerts!) and climb inside the heads of CRCs and participants to better craft our forms for these study VIP’s.

Click either image below to sign into our on-demand webinar library. Then watch, share, and respond with comments to add your expertise to the conversation.

The Kitchen Sink: See everything OpenClinica forms can do for you

In just thirty minutes, explore all of OpenClinica’s form capabilities, each doing its part to ensure better data, faster! See how skip logic, autocomplete, clickable image maps, real-time edit checks, autosave and a LOT more all work together on beautiful UX to drive cleaner data from the start.

Recording now available. Enter our webinar library.

Download the kitchen sink form (customers only)

 

Configurable roles, participant limits, and more now part of OC4

Starting today, data managers building their studies in OC4 will find a whole new level of control at their fingertips.  Our newest release allows data managers to:

  • Enforce a Participant ID naming convention of their choosing (e.g. [site number]-[participant ordinal])
  • Restrict users from adding participants once an expected number of participants is reached
  • Configure roles and permissions
    • “Clone” and apply a unique name to a pre-defined user role
    • Grant users of that role, and only such users, access to particular forms
  • Leverage REST API services to:
    • add a participant
    • add participants in bulk
    • export a list of participant IDs
    • import data into forms

While role configuration is arguably the keynote of this release, all of these features enable managers to exert fine-grained control when study size, design, or duration require it.

Participant ID Naming Conventions

Consider a large, multi-center study expected to enroll hundreds or even thousands of participants. In these cases especially, data managers, trial managers, and monitors need a compact, informative lexicon to quickly gain insight into study progress, put issues into context, and refer questions to the best source of information. A standardized, meaningful participant ID is a key component of that lexicon.

Enforcing a standardized ID in an OC4 study is simple. Just head to your Settings tab, edit the Participant ID Settings, and select System-generated as your method of ID creation. Then apply or adapt the template provided.

Using simple syntax, data managers can define a convention that makes an ID truly informative. When site users add a participant, the convention is automatically applied.  Following the example above, GER002-005 easily translates as the 5th participant enrolled at Site 002 in Germany. If participants GER002-005 and GER007-20 both show a randomization date of today, we can quickly and easily glean some useful information: at least 25 participants have been randomized in at least 2 activated sites in Germany, with Site 007 having randomized 4 times as many patients as Site 002. While users of OpenClinica Insight already have up-to-date metrics like this at their disposal, other users will now have an easier time extracting them from spreadsheets: it’s easy to parse out relevant information from a string in Excel when that information is always in the same place.

Participant Limits

Regulatory bodies frequently mandate enrollment caps in high-risk studies. Exceeding that cap then becomes a major compliance hazard. The latest release of OC4 offers a fail-safe to protect against that risk, which can be significant in fast-recruiting, multi-center trials.

When the checkbox below ‘Expected Number of Participants’ is selected, the expected number becomes a hard limit. No user can add a participant, whether at the site or study level, once the number of (non-removed) participants reaches that limit.

Role and permission configuration

Some forms are meant only for properly trained users. Cognitive assessment ratings provide one such example. Administering the MMSE or ADAS-Cog requires more than just knowing what those acronyms stand for. (Curious?) Those scales are only meaningful in the hands of trained cognitive raters. As such, a form including the MMSE or MoCA that’s available to any user with data entry responsibilities jeopardizes data quality and risks protocol deviations. The latest release of OC4 enables data managers to restrict access to these forms.

The first step is to tag those forms you need to restrict. You can customize the color and name.

Once created, you can apply the permission tag to all relevant forms.

Finally, you’ll create a custom role with permissions to access the forms you’ve tagged.

Custom roles are based on standard roles at either the study level (Data Manager, Data Specialist, Data Entry Person, and Monitor) or site level (Investigator, Clinical Research Coordinator, or site-specific Monitor). Customs roles come with the same core permissions as their standard counterpart. However, by allowing access to tagged forms, data managers enable only users with the custom role to access equivalently tagged forms. (These users may also access untagged forms.)

In the example above, only users with the RATER role have access to the MMSE and ADAS-COG forms. Other users will not be permitted to: open the form in edit mode, review-only mode, or read-only mode; view queries on the form; SDV the form; extract the form clinical data in a dataset or participant casebook; or view common event tables for the form on the Participant Details page. However, the clinical data can be piped (e.g. though a cross-form note or calculation) into a form that is readable by users without the RATER tag. In this way, read and write permissions are separable.

REST API services

The capabilities of our REST API continue to expand in this release as well. It’s not easier than ever to…

  • add a participant
  • add participants in bulk
  • extract a list of participants
  • import data

… through web services. OC4 uses the open source framework Swagger to help our users build and test their APIs. You can find the link on your study’s Administration page.

Last night’s release was the 5th overall since the creation of OC4 last year (not counting interim enhancements). It’s our most ambitious release to date, and in keeping with our mission to let data managers take total control with ease. As always, we welcome your input through the comments section below, and we look forward to continuing our close and successful collaboration with OC4 users. Not using OC4? Let us show you the power that awaits!

Dive into deep learning on October 16

We are excited to announce that MIT professor and MacArthur genius grant receipient Dr. Regina Barzilay will deliver OC18’s Tuesday keynote on the clinical applications of deep learning.

From every pixel of their MRI scan to each word in their medical chart, patients bring a wealth of data to their clinical trial or care journey. We can learn from this data? It may not be obvious to human minds, but neural networks trained on historic data and outcomes may be capable of producing models that predict, for new patients, everything from future morbidity to treatment fit. 

Don’t miss this fascinating talk. Register for OC18 while early bird rates are still in effect.

About Dr. Barzilay

Regina Barzilay is a Delta Electronics professor in the Department of Electrical Engineering and Computer Science and a member of the Computer Science and Artificial Intelligence Laboratory at the Massachusetts Institute of Technology. Her research interests are in natural language processing and the applications of deep learning to chemistry and oncology. She co-directs the pharmaAI consortium at MIT. She is a recipient of various awards including the NSF Career Award, the MIT Technology Review TR-35 Award, Microsoft Faculty Fellowship and several Best Paper Awards at NAACL and ACL. In 2017, she received a MacArthur fellowship, an ACL fellowship and an AAAI fellowship. She received her Ph.D. in Computer Science from Columbia University, and spent a year as a postdoc at Cornell University.

Deadline to submit OC18 abstract is August 24

Submit an Abstract for OC18

Deadline: Friday, August 24

Would you like to share a case study with fellow power users? Eager to share your domain expertise with other data managers? Submit an abstract for a chance to take the stage at OC18. We love to showcase projects that demonstrate an innovative use of OpenClinica. But if you simply have an original take on the interestion of personalized medicine and data management, we want to hear from you.

We encourage a broad interpretation of this year’s theme.

  • Have you led or participated in research that delved beyond an indication and eligibility criteria in its participants?
  • Have you personalized study workflows for your team?
  • How are you personally motivated by the research you do?

All are valid prompts for developing a session.

Still need some inspiration? Check out the OC17 program.

We received a record number of submissions in 2017, so we can’t guarantee extending the deadline past August 24. Tell us your idea today!

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?

Click to see enlarge version

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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