Opening Doors to Data

Features & functionality to make your job easier. Highlights include:

• eConsent: Create engaging digital consent experiences for remote and in-person participants
• Auto-generate annotated eCRFs: Makes it easier to understand study configurations
• Automated & Centralized Calendar: Simplified approach to updating and maintaining protocol calendars to meet shifting needs
• Streamlined navigation between key pages provide time-saving shortcuts

The session is intended to give an overview of the SDTM model, with a walk through of the common steps needed to classify clinical data into the SDTM model, selecting the domains and variables etc. The second half of the session covers the common programming steps needed to convert EDC data into SDTM-IG datasets, highlighting areas common to all studies and the benefits of a standardized approach.

This session will show how easy it is to randomize with the OC Randomize module and the options available to configure both unblinded and blinded trials. The session will show how inventory for double blind trials can be managed in different ways and will discuss what you should consider when planning a trial to ensure sites are adequately stocked with supplies.

eConsent goes beyond the digitally-compliant signature to give you an easy way to create and share engaging digital experiences for remote and in-person participants.This session will show you the different ways the OpenClinica eConsent module can guide your participants through the informed consent process by demonstrating how to build an effective consent form and what the experience could be like from a participant’s point of view in an in-person or remote setting.Learning Objectives:

• How to build an eConsent form that is an interactive experience for the participant rather than a document they have to read
• What it’s like for a participant to consent using OpenClinica
• What tools the OpenClinica eConsent module provides for tracking consent

This presentation will demonstrate how you can build a dashboard using both the simple report builder and SQL in Insight. This will allow your study monitors to identify only the forms and events that require verification.  With a simple click on the dashboard, you will be directed to the participant details page, a filtered SDV table, or a filtered queries table on OpenClinica. Learning Objectives:

• How to consolidate all your insight reports  into a single dashboard
• How to create filters in a dashboard
• How to hyperlink from your dashboard into your OpenClinica environment

The Vulcan Accelerator aims to bridge data transfer gaps between Clinical Care and Clinical Research. This session will describe how Vulcan operates, its success to date and future plans, with a focus on the impact across the UK and Europe.

Migrating data mid-study is no small feat. But getting data out of a legacy system and into OC’s EDC is more than worth it. Join this session to get the good, the bad and the ugly. We’ll discuss:

• Background – Why migrate?
• Process
• Timings
• Challenges
• Lessons learned

This presentation will demonstrate how you can utilize OpenClinica’s flexibility with the EDC where you can use the form designer to create a unique workflow for Image Adjudication. The model has image reference, slide verification, and in-form timers to capture various metrics of the adjudication process. Pathologists can view these forms and not interfere with one another, while recording their findings. The model also demonstrates data imports and read-only fields that will be useful to the pathologist during their image reads.

• How to link external hyperlinks to image references
• How to rethink use cases for OC4
• How to create start and stop timers for testing reaction time
• How to use import and calculations to display information for data export

Insight is like a toolbox. This session will highlight some of the key tools Insight provides – including some you might not know about –  and how to use them to manage your studies more efficiently. You will learn:

• What reports come built-in with every study
• How to build custom reports and the easiest ways to reuse them across studies
• Where to find everything you might want to know about your Insight database
• How to use Insight to build tools for adjudication, RBM, and AE alerts
• What possibilities exist for embedding Insight dashboards for site/study personnel or patients to access
• The best ways to extract your data from Insight

Initially using OpenClinica 3, before several key features were available (e.g. SAS extracts, Insight, etc.) we developed our own internal processes to run studies. With the advent of OpenClinica 4 many of these processes were updated to work with the new build system; however, some have required a re-think.

Over the years of using OpenClinica 4, we have improved our system of database build to now use a modified Excel template with embedded VBA macros to make building and testing easier. In particular we have developed a way of working that allows us to use one Excel template to create multiple form variations, each with its own Excel file. In addition, we have extended this system to more easily build and test forms, even when they make use of data piping – something that normally is only possible by publishing the study and entering suitable test data.

SMDS?! 10 years ago, our company was looking into Safety Data Management Systems to handle client pharmacovigilance efforts. We already had OpenClinica’s CDMS Community version deployed for multi-national studies and were very comfortable with supporting all three system tiers (front-end, application, and database).

OC Community’s flexibility and our familiarity with it made it a perfect fit for an SDMS, especially when we determined that implementing a COTS system would be very costly throughout its lifespan. Within six months of the ‘go’ decision and using only internal resources, we set-up, validated, and deployed a fully functional SDMS using OpenClinica’s CDMS as the primary technology stack.

Not only was it the least expensive choice from an implementation perspective, but our intimate knowledge of the entire system made it the least expensive choice in terms of long-term support. Today, we have migrated the SDMS to the current OpenClinica v4 Enterprise technology stack (including Insight and Participate – planned) and are working closely with OpenClinica’s team to optimize the build out.

This discussion will delve into the what, whys, and hows of using the OpenClinica v4 Enterprise as the core platform for a full-featured Safety Data Management System.

Attracting & retaining trial participants is getting harder. CRCs are burnt out. Learn how to leverage OC to help increase engagement & satisfaction for participants and clinicians alike.

This presentation will demonstrate how you can utilize OpenClinica Participate to design forms for participant data entry. These electronic Patient Reported Outcomes (ePRO) forms are fully integrated in the study. Participants can enter data at scheduled time, and the data is immediately available for review by site and Study-level users. Participant can access these forms on their own devices (smart phone, tablet, laptop, or desktop computer) and submit them back to the study. Learning Objectives:

• How to activate Participate
• How to control which forms are available for each participant
• How to invite participants
• How to design Participant forms for efficient data entry

In this presentation you will learn calculations, functions and logical expressions in a simple and understandable format. Creating eCRFs and using XPath calculations to optimize your study efficiency and data quality has never been easier. You’ll walk away knowing:

• How to improve data quality with form design best practices and study build methodologies.
• How to improve data reliability with calculations, logical expressions, and error checking methods
• How to use complex calculations to process, move, and reuse data for skip logic and edit checks
• Learn how to have your forms self-validate and take burden off your users

Two members of the IT team reflect on the challenges and their experiences of rapidly developing the RECOVERY trial’s IT systems during the COVID-19 pandemic.

Dive into the only EHR to EDC solution capable of auto-populating your eCRFs on study day one. Practical, scalable functionality that’s proven to lessen the burden for researchers, sponsors and patients alike. Learn how to:

• Get finalized, verified data on study day one
• Ease the burden for CRCs with automation
• Simplify enrollment, data sharing and participation for patients
• Enhance decision support for site and sponsor stakeholders
• Say so long to SDV!

An open forum to ask questions around issues specific to you. Questions submitted in advance to help our team prepare. Bring it!