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Jun 26 2018

Where Did the Eyeball Go? A Look at RaveX

Dena Hughes, Senior Implementation Specialist, PROMETRIKA, LLC.

PROMETRIKA is pleased to announce that we have successfully implemented RaveX in our Data Management department. RaveX is the latest version of Medidata’s popular Electronic Data Capture (EDC) solution for collecting clinical trial data. Its predecessor, “classic” Rave, has been in use in the industry since 2001.  With our first configuration and release (June 2018) of a clinical trial database utilizing RaveX, PROMETRIKA has navigated the waters of this new Rave user interface (UI) and its Cloud Administration component. In so doing, we have developed a standard set of re-usable processes and procedures around implementation of Cloud Administration, approaches that take advantage of new features and thereby reduce the time and effort required for managing this component of a database using RaveX.

But what, exactly, is RaveX? With classic Rave performing as a tried and true solution, why should you consider switching to RaveX? What benefits would you gain? What pitfalls might you encounter? And who can help you navigate these new waters?

What is RaveX?

RaveX is primarily an updated UI, replacing the current classic look with a dynamic display and more efficient navigational controls. In addition, behind the scenes, access to RaveX is managed through Cloud Administration, bringing both a new look and a more streamlined process to granting user access to EDC and other integrated Medidata products such as Coder and Safety Gateway. And RaveX, unlike classic Rave, is automatically upgraded, meaning you will always be running the most current version.

What RaveX is not? A complete overhaul of the entire Rave EDC system. Although it has a new look and feel, the RaveX UI is supported by the same outward-facing architecture when it comes to building databases and managing system features. For database builders, Architect remains the same, only now some of the dynamic-design programming surfaces immediately in the RaveX UI, rather than requiring additional action on the part of the end-user. For system administrators, the core configuration settings are as they were, so no need to re-think your entire URL configuration.

Why RaveX over Classic Rave?

After more than 15 years of designing and building study databases in classic Rave, it admittedly was not an easy transition for me to the new RaveX UI. Features to which I’ve previously been able to navigate with my eyes closed are no longer in the same places. Log forms look foreign, yet oddly intriguing. And where did the eyeball icon go? For that matter, what happened to all of my icons, they all look so different now. What is this colored badge? And how do I find my tasks? Is this new UI and its associated Cloud Administration requirements making my work simpler and more efficient or is the change management process required to get there not worth the effort?

These are the types of questions you may ask when first navigating the RaveX and Cloud Administration waters, but there are a number of advantages to staying the course and adopting these newer products for your organization.

Efficiencies in Account Management

Cloud Administration, required for RaveX databases, introduces the concept of “Platform Roles,” which are not just the EDC roles to which we are accustomed but comprehensive roles that bring together multiple components, simplifying access-granting activities and reducing the possibility of granting inconsistent access to the same types of end-users.

Implementing these umbrella roles requires a slight shift in thinking and there are a few manageable pitfalls that must be avoided around component assignments when creating your Platform Roles. For many of us, updates to our account management processes and request forms will also be required. But the simplification of requesting access for a single role, rather than multiple components, eases the burden on end-users and system administrators alike. Additionally, as Medidata integrates more products into Cloud Administration, the ability to manage the currently-multiple access points through a single entryway will bring added value.

Improved Role-Based Testing and Navigation

Data Managers spend a considerable amount of time performing user acceptance testing (UAT) of EDC builds. In many cases, this includes logging into Rave EDC with several different roles, confirming configurations such as view- and entry-restrictions or signature requirements. In classic Rave, this requires numerous open browser tabs or, worse yet, for core configurations that don’t allow for multiple logins, the use and maintenance of multiple separate test accounts, one for every testing role required.

In RaveX, this process is streamlined by the new ability for the user to switch to a different role, on the fly, within the same browser window. Need to test as a data manager? Select data manager from your profile dropdown list of roles. Now need to view as a clinical research coordinator (CRC)? No need to open another browser tab or log in with a separate CRC account – just pick the CRC role from your profile dropdown list and your view is shifted to that role. The benefits in time savings during testing activities are obvious.

Similar efficiencies are available to database builders and system administrators, with new dropdown navigation menus allowing the user to switch environments on the fly or go from working in EDC to accessing the system administration screens with a single click.

Simplified Visual Cues

How do you reduce your overview status icons from a whopping 16 to a more manageable 8? Switch from classic Rave to RaveX. I admit to missing the eyeball icon, but there is beauty in simplicity and greater ease for end-users when the eyeball is not staring blankly back.

For long-term Rave EDC users such as myself, the change in icons may be one of the more difficult new features to manage. But by simplifying the visual indicators of what needs to be done –  entering data, addressing queries, taking some sort of action, signing a form – the need for constantly referencing the icon key fades and the ability to quickly see where action is needed rises to the surface. See a Flag? Click on it and the colored badges at the top of the form will tell you – in words, not pictures – what action is required. It’s a new look but more directly informative to the end-user.

Faster and Cleaner Data Entry

The switch from classic Rave to RaveX isn’t just about the efficiencies we can gain as EDC builders, system administrators, and people that monitor and review the clinical data from within the platform. More importantly, it’s also about the quality of the data as it is being entered by the clinical sites. Easing the ability for sites to correctly enter dates by providing a calendar control, firing real-time queries for missing or non-conformant data as soon as the clinician navigates away from a field, prompting immediate data correction rather than the save-and-come-back later approach, making a field dynamically visible as soon as the triggering data is entered, thereby eliminating that same save-and-come-back later architecture; these are the new RaveX UI features that can contribute to cleaner and more efficiently entered data, with the resultant downstream effects of fewer outstanding queries and missing results.

Automatic Upgrades and Bug Fixes

In addition to improved data quality, perhaps one of the most pragmatic reasons for switching from classic Rave to RaveX is that RaveX is always automatically upgraded, allowing you to take instant advantage of new features and bug fixes. Furthermore, if you are using other integrated Medidata products, such as Coder, the full features of these integrated products are also immediately available to your RaveX databases.

What We Can Do To Help

PROMETRIKA’s Data Management and Database Programming teams are now well-versed in navigating the new RaveX UI and understand how differences in study and form design will render in the interface. We are familiar with the classic Rave features that are no longer supported or that now require a new way of navigating, and we can provide consultation and/or train sponsors in these areas. The knowledge we have gained through direct experience in implementing RaveX and Cloud Administration can be leveraged to facilitate a smoother start-up for your adoption of this new UI. It’s a leap worth taking.

May 30 2018

Must We Fast Before Lipid Measurements?

Amarachi Umez-Eronini, MPH, Senior Statistical Programmer / Biostatistician II, PROMETRIKA, LLC.

For decades, fasting for 8 to 12 hours prior to blood draw has been the recommended guideline for measurement of lipid profiles.  But does fasting have a clinically significant outcome on the results of lipid level measurement in patients?  Using data provided by the Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 (PROVE-IT-TIMI 22) trial, our group examined this question.

Continue reading “Must We Fast Before Lipid Measurements?”

Apr 20 2018

Keys to Success in Medical Coding With Medidata Coder®

Cathy Hult, Director, Data Management, PROMETRIKA, LLC

Coder is a Medidata application designed for mapping verbatim terms (e.g., adverse events [AE], concomitant medications [CM], and medical history [MH]) to specific terms in industry standard dictionaries (i.e., MedDRA, WHODrug).  Coder is integrated with the Medidata Rave EDC system, allowing terms entered in Rave EDC to be directly transmitted into the Coder application for processing, and then transmitted back into Rave once coding is complete.

PROMETRIKA, LLC was accredited in the Coder platform in March 2017.  In the short time we have been using it, the flexible Medidata coder platform has already proven efficient in assigning codes to verbatim terms in real time when integrated with Rave studies.  Continue reading “Keys to Success in Medical Coding With Medidata Coder®”

Mar 26 2018

SDV – What is it good for? Absolutely nothing?

Stephen Cropper, Senior Clinical Research Associate, Clinical Operations, PROMETRIKA, LLC

In recent years, much has been said about Source Document Verification (SDV), the comparison of information reported by an investigator to original source records to confirm its completeness, accuracy, and validity. The term SDV seems to mean different things to a lot of people. Some suggest that SDV is only the simplest form of transcription checking, with a goal of simply ensuring that the eCRF matches the patient’s medical records.

The accepted norm for assuring clinical trial quality had been 100% SDV, but there is no evidence that suggests it improves overall data quality, and FDA & ICH regulations do not require it. A process that includes 100% SDV review can be very time-consuming and expensive. Has the time come to change how we approach SDV in clinical research? Continue reading “SDV – What is it good for? Absolutely nothing?”

Feb 28 2018

The Best Way to Develop Regulatory Submission Documents? Survey Says . . .

Christine Quagan, Senior Medical Writer, PROMETRIKA, LLC

Recently, the Medical Writing Team at PROMETRIKA completed our second New Drug Application (NDA) submission within a year.  The process of developing the suite of documents for each submission – including the integrated summaries (ISS and ISE), clinical summaries (SCS and SCE), and clinical overviews (COS and COE) of safety and efficacy – involved much collaboration among the writers, biostatisticians, and the sponsors’ clinical development teams.  Without it, the team would not have been able to meet the tight submission timelines set by the sponsors.

With our experience fresh in our minds, we read the article “A Pilot Survey of Strategies for the Development of Clinical Summary Documents” in a recent issue of the American Medical Writers Association Journal.  How similar was our experience to other writers who developed submission documents? Continue reading “The Best Way to Develop Regulatory Submission Documents? Survey Says . . .”

Jan 31 2018

Best Friends, Best Practices: The Synergy Between Biostatistics and Medical Writing at PROMETRIKA

Christine Quagan, Senior Medical Writer, PROMETRIKA, LLC

Recent articles in Medical Writing, the Journal of the European Medical Writers Association, recommend collaboration between medical writers and biostatisticians. Authors from one Russian CRO even consider medical writers and biostatisticians to be “best friends forever”!1 This friendship thrives on communication and collaboration.2

With over a decade of collaboration, PROMETRIKA’s medical writers and biostatisticians exemplify the “best friends” described in the articles. An open line of communication is the foundation for the collaboration, enhanced by aligned standard operating procedures (SOPs). The medical writer and biostatistician can then develop a unified approach to meeting industry best practices, including agreeing on templates and style guides, timelines, and level of review required for each draft document. Continue reading “Best Friends, Best Practices: The Synergy Between Biostatistics and Medical Writing at PROMETRIKA”

Dec 29 2017

ePRO Data and Rave: A Match Made in the [Patient] Cloud

Kathy Zheng, MPH, Senior Project Manager, PROMETRIKA, LLC

PROMETRIKA was the first Medidata CRO partner accredited in the Medidata Patient Cloud® platform. As early adopters, we experienced the growing pains of using the Patient Cloud, when we used it as an ePRO solution with Rave. A recent project with a third-party vendor, a leader in the ePRO field, provides a case study for contrasting our experience with the Patient Cloud to that of integrating other ePRO systems with Rave. Continue reading “ePRO Data and Rave: A Match Made in the [Patient] Cloud”

Nov 29 2017

Global Library Data Standards: How They Benefit Cross-Functional Groups at PROMETRIKA

Jennifer Yee, Clinical Data Manager III & Amarachi Umez-Eronini, MPH, Biostatistician I / Statistical Programmer III, PROMETRIKA, LLC

The Data Standards Series: Part 3

As a digital repository for data collection instruments in a Clinical Data Management System (CDMS), a global library (GL) is used to streamline the database build process by increasing quality, time savings, and cost efficiencies.  Although it’s a tool primarily used by Data Management and Database Programming, the GL benefits extend to multiple functional groups within a Clinical Research Organization (CRO).

At PROMETRIKA, some of the groups impacted by the availability of a GL are:

  • Data Management and Database Programming
  • Biostatistics
  • Clinical Operations
  • Pharmacovigilance
  • Project Management

Each of these areas gains unique advantages from the use of our global library.

Continue reading “Global Library Data Standards: How They Benefit Cross-Functional Groups at PROMETRIKA”

Oct 23 2017

CDASH and SDTM: Why We Need Both!

Amarachi Umez-Eronini, MPH, Biostatistician I / Statistical Programmer III, PROMETRIKA, LLC

The Data Standards Series: Part 2

Data Standards Developed by the Clinical Data Interchange Consortium

To streamline the exchange of clinical and nonclinical research data and ensure uniformity across studies submitted to the U.S. Food and Drug Administration (FDA), the Clinical Data Interchange Standards Consortium (CDISC), has developed data exchange standards to streamline clinical research and enable connections to healthcare.  As stated on the CDISC website introduction, “Unlocking cures is our life’s work.  At CDISC, we enable clinical research to work smarter by allowing data to speak the same language.”

Within the CDISC organization, there are several data exchange standards. The most commonly used exchange standards at PROMETRIKA include: Clinical Data Acquisition Standards Harmonization (CDASH), Study Data Tabulation Model (SDTM), and Analysis Data Model (ADaM).  These standards allow sponsors to submit study data in electronic format to the FDA or other regulatory agencies.  As of December 17, 2016, with the exception of CDASH (though strongly recommended), the following data formats, supported by the FDA and listed in the FDA’s Data Standards Catalog, are required when submitting study data. Continue reading “CDASH and SDTM: Why We Need Both!”

Sep 30 2017

The Global Library: The Benefit of Standards in a CRO-Sponsor Partnership

Jennifer Yee, Clinical Data Manager III, PROMETRIKA, LLC

The Data Standards Series: Part 1

The top priority of a Clinical Research Organization (CRO) is to help a sponsor conduct a successful clinical trial. That success is measured in data quality, process efficiency, and cost effectiveness. In order to achieve these goals, many organizations find they benefit from the development of a global library. A global library (GL) is a digital repository in a Clinical Data Management System (CDMS) that contains data collection instruments, such as electronic case report forms (eCRF) and their associated programming elements.

During database build, the library functionality allows for the copying of pre-validated objects, such as variables, code lists and edit checks, from the GL into new projects. Confidence in the pre-validation of the GL allows these objects to be copied without reprogramming or testing. By eliminating these time-consuming tasks, CROs can develop projects with design consistency, significant time savings, and reduced cost; features critical to the success of a study.

Continue reading “The Global Library: The Benefit of Standards in a CRO-Sponsor Partnership”

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