Main User Group Conference
Monday, 15 May, 11:30 am – 4:30 pm
11:30 – 12:30: Welcome Lunch
12:30 – 1:30
Track A: New Feature Round Up!
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
Track B: So Long, SDV!
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!
1:30 – 2:30
Track A: Building Data Pipelines: Different Modes of Data Capture.
From paper to eSource, understand all the ways OC can support and streamline your data capture.
Track B: Customer Case Study: Automating Data Transformations & Imports.
In this session, you will learn how Siemen’s leveraged our Data Transformation Module to successfully and easily import messy real-world data. As you know — working with raw data is painstaking. More often than not, the information really need is hidden among miscellaneous data points. The Data Transformation Module picks apart the data that you need and transforms it into a format that is compatible with OpenClinica’s data import processes. The module uses scripts in an automated fashion to reduce your workload and bring the necessary information into OpenClinica. Come hear more about how Siemens uses this feature and how you can do the same.
2:30 – 3:30
Track A: Customer Case Study: Getting to SDTM: Designing for the End Goal.
Track B: Customer Case Study: Migrating Data Mid-Study - Lessons Learned from Migrating 12 Studies in 12 Months.
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
3:30 – 4:30
Track A: Partner Presentation: Randomization and Supply Management.
Track B: Ditch the Spreadsheet! The Power of Insight to Ease your Workflow.
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
5:00 – 8:00: Included in registration: Dinner & drinks at Coco Momo Kensington!
Tuesday, 16 May, 8:00 am – 4:00 pm
8:00 – 9:00: Breakfast
9:00 – 10:00: Keynote: Opening Doors to Data
10:00 – 11:00
Track A: Introducing eConsent: Beyond the Signature.
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
Track B: Image Adjudication
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
11:00 am – 12:00
Track A: Your Digital Front Door: Improve Participant & Clinician Satisfaction.
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
Track B: Clinical Monitoring with OpenClinica.
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
12:00 – 1:00: Lunch
1:00 – 2:00
Track A: Sneak Peek: Releases & Roadmaps.
Plan ahead! Get the low-down on upcoming releases and roadmaps.
Track B: Calculations and Functions in Forms: Get Smarter about Study Efficiency and Data Quality.
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
2:00 – 3:00
Track A: Customer Case Study: Alternative Ways to Use OC: Safety Data Management Systems.
We love innovative thinking! Learn how one customer uses OC as a safety data management system (SDMS).
Track B: Special Customer Presentation: TBD.
3:00 – 4:00
Farewell Tea: Ask Us (almost) Anything!
An open forum to ask questions around issues specific to you. Questions submitted in advance to help our team prepare. Bring it!
Note: Registration includes breakfast, lunch, tea and Monday’s dinner.
Workshops
Wednesday, 17 May, 8:00 am – 3:30 pm
Workshop One: The Art of the Possible: Insight Dashboards & Reporting
In this full-day workshop you will dive into the best-kept secrets of OpenClinica Insight. You’ll learn how to take full advantage of built-in reporting and dashboard creation to get your job done easier, faster and more accurately than ever before. It’s past time to ditch spreadsheet reporting and let purpose-built technology do the heavy lifting for you.
Suitable for: All skill levels
Learning objectives: You’ll walk away knowing:
-
- What data are in Insight and how they are organized
- Where to find key data reports across: clinical data, statuses, summary-level study information, SDV, Queries and audit logs
- How to build and use both basic and advanced visualizations using built-in tools
- How to build dashboards for yourself and external stakeholders
- What the basics of relational databases are and their value to Insight success
- How to combine data from different tables
- What SQL is, how to craft SQL queries, and which built-in tools help you work with SQL in Insight
We’ll also explore advanced Insight capabilities such as embedded reporting on PDP, Participate or third-party apps; segments and metrics; URL generation for linking to OC pages.
Workshop Two: Advanced Form Building & Logic Calculations
Are you ready to take your OpenClinica form-building skills to the next level? This full-day workshop will cover best practices for creating eCRFs and advanced XPath calculations to help you optimize your study efficiency and data quality. In a step-by-step process, you will add new techniques and skills across key form concepts. We’ll explore guiding principles of study design; design roles and responsibilities, how to create libraries, manage timelines, develop time-saving cross-form calculations, and how to test your study design process before implementation.
Suitable for: Users who have either attended super user training or have some form building experience.
Learning objective: You’ll walk away knowing:
-
- How to improve data quality with form design best practices and study build methodologies
- How to improve data reliability through cross form calculations and error checking methods
- How to use complex calculations to process, move, and reuse data for skip logic and edit checks
- When and how to use XPath expressions
- How to add filters to your expressions to target specific datasets based on user entered data
We’ll also focus on developing the problem-solving skills you need to walk through any form-building challenge.
Workshop schedule (both workshops):
8:00 – 9:00 – Breakfast
9:00 – 12:00 – Workshop, part one
12:00 – 1:00 – Lunch
1:00 – 3:30 – Workshop, part two
Note: Workshops held in parallel with each other and the first day of SUT. Additional fees apply for workshops and super user training, See registration page for details. Registration includes breakfast, lunch and tea.
Super User Training (SUT)
Wednesday – Friday, 17 – 19 May
Our most comprehensive course that prepares data managers and study designers to productively work with OpenClinica. This highly interactive, in-depth training is designed and taught by the same professionals who design, build and test the OpenClinica software.
Learning objective: Become a confident and effective study builder; enhance existing skill; optimize settings and workflows; learn often overlooked functionality; troubleshooting; tips and tricks.
Suitable for: All skill levels
Note: The first day of SUT is held in parallel with workshops. Check workshop tab for details.
Wednesday 17 May
8:00 – 9:00 – Breakfast
9:00 – 12:00 – System demo; introduction to workspaces; form building basics
12:00 – 1:00 – Lunch
1:00 – 3:30 – Publishing to test; testing form logic; review and revise; leveraging OC resources and support
Thursday 18 May
8:00 – 9:00 – Breakfast
9:00 – 12:00 – Publishing to production; sharing the study internally and externally
12:00 – 1:00 – Lunch
1:00 – 3:30 – Advanced form features (e.g. calculations, cross-form logic, external lists)
Friday 19 May
8:00 – 9:00 – Breakfast
9:00 – 12:00 – Data imports; data extracts; reporting, dashboards and data visualization
12:00 – 1:00 – Lunch
1:00 – 3:30 – Managing ePRO and randomization modules; notification actions; scheduling rules
Note: Additional fees apply for workshops and super user training. See registration page for details. Registration includes breakfast, lunch and tea.