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.

From multi cohort Phase I’s to integrated Phase III’s, FDA eyes efficiency

Two guidance documents, released a month apart this summer, suggest that the FDA is taking up a concern that sponsors and patients feel all too acutely: the need for speed.

That’s not a word anyone involved in clinical research takes lightly, with lives and knowledge on the line. But by issuing guidance on EHR integration in July, followed this month by guidance on simultaneous cohorts in Phase I oncology trials, the United States’ foremost regulatory body is placing a premium on efficiency. It’s not fair, or accurate, to claim that the policymakers at the FDA have never been interested getting safe, effective medicines to market quickly.  Like the population they serve, these policymakers are moms and dads, brothers and sisters, and patients. But they are also stalwarts of caution. That’s why their recent guidance communicates so much, even beyond its content.

First, what is the content? July’s guidance document, Use of Electronic Health Record Data in Clinical Investigations,  “clarifies [the] FDA’s expectations when EHRs are used as a source of data in [prospective] clinical investigations.” Unabashedly, the guidance “encourages sponsors and clinical investigators to work with entities that control EHR systems, such as health care organizations, to use EHR and EDC systems that are interoperable or fully integrated.” (The guidance defines interoperable systems as those capable of piping data from one to the other through a validated process. Think of a well-tested and well-documented API. Fully integrated systems, by contrast, “allow clinical investigators to enter research data directly into the EHR.”) Guidance sections with the most specific recommendations include those on:

  • structured and unstructured data (the first being preferred, but the second allowed if additional reliability and quality measures are in place)
  • validation (required for the EDC, but not for the EHR)
  • data from multiple EHR systems (“data from another institution’s EHR system may be used and transmitted to the sponsor’s EDC system provided that data sharing agreements are in place”)
  • ONC Health IT Certification for EHR system (“FDA encourages the use of such certified EHR systems”)
  • data custody and audit trails
  • maintaining the blind across all relevant systems
  • Informed Consent that makes the use of EHR data clear

The recommendations are sound, if not surprising. But the scope, which includes prospective studies but excludes postmarketing and registry ones, signals a focus on investigations designed to make new therapies available, or existing therapies available for new indications. A need, in other words, for speed.

What about the August guidance? Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics aims to bring order–and a seal of acceptability–to trials that are “intended to expedite development by seamlessly proceeding from initial determination of a potentially effective dose to individual cohorts that have trial objectives typical of phase 2 trials (i.e., to estimate anti-tumor activity).” These trials pose particular risks, most salient among them the possibility of exposing more participants than necessary to toxic or suboptimal doses. Because of these risks, sponsors should only consider an expansion cohort design for studies related to indications without curative therapies.  What’s more, to mitigate these risks, the guidance states that “it is imperative that sponsors establish an infrastructure to streamline trial logistics, facilitate data collection, and incorporate plans to rapidly assess emerging data in real time and to disseminate interim results to investigators, institutional review boards (IRBs), and regulators.”

Sections V, VI, and VII, dealing with considerations based on cohort objectives, statistical considerations, and safety considerations respectively, don’t lend themselves to summary, mandating study conduct requirements for physicians, pharmacologists, pharmacovigilance officers and biostatisticians. (To get a sense of the detail, note that both guidance on Food-Effect Bioavailability and Fed Bioequivalence Studies and Pharmacokinetics in Patients With Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing and Labeling are pre-requirements.) That such specific directives are issued here in a draft guidance hints at an urgency understood: getting quickly to Phase III safety and efficacy findings starts with a Phase I that can transition quickly transition to a Phase II.

Beyond the text of these documents, the FDA’s response to the industry’s need for speed is audible, and commendable. Why did the response (or so explicit a response) come now? We can only speculate. Certainly, the roads to knowledge are getting faster by the day. Just consider the early successes of machine learning. And despite some therapeutic victories, cancer is by no means in retreat. The will and the way are clear. The FDA has just supplied a good deal of the how.


Unsure whether your data capture system is build for speed? Versatile study build features, a robust API, and forms that drive “quality on entry” are all must haves.

 

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?

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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

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“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.