Nice flight home?
Thank you to everyone who helped make SCDM 2019 another fantastic learning opportunity. We were delighted to catch up with old friends and make dozens of new ones. If you weren’t able to visit our booth, attend our product showcase, or catch our panel discussion on key performance indicators, don’t worry — we captured the insights for you. You can download articles, best practices, and more right from this page.
We captured (Balti)more.
Thank you to everyone who helped make SCDM 2019 another fantastic learning opportunity. We are delighted to catch up with old friends and make dozens of new ones. If you weren’t able to visit our booth, attend our product showcase, or catch our panel discussion on key performance indicators, don’t worry — we captured the insights for you. You can download articles, best practices, and more right from this page.
“Better Forms, Better Data”
Product showcase on Tuesday, October 1, 9:30AM to 10:15AM, Laurel A
If data is the lifeblood of a study, then forms are its arteries. The appearance, behavior, and “intelligence” of your eCRFs may be the greatest determinant of data quality. OpenClinica forms are designed to delight CRCs and participants, prompting accurate and timely entry with the aid of cross-form calculations, sophisticated skip logic, real-time edit checks, multimedia question types, autosave, and more. Take a brief tour of what OpenClinica forms have to offer as we proceed through an example study. You’ll leave with a newfound appreciation of the once humble, but now awesome, form.
- Introductory slides
- A usability design checklist for Mobile electronic data capturing forms: the validation process (article)
- Data Collection of Medication – Impact of Autocompletion in eCRFs on Efficiency and Data Quality (article)
- EDC Success Guides (best practices and examples in form design)
- The Ultimate eCRF Design Guide
Measuring What Matters: KPIs for Data Quality, Speed, and Cost
Panel Session on Tuesday, October 1, 11:30AM to 12:30PM, Grand Ballroom VI
Smita Asare, Executive Director, I-SPY Trials Operations at Quantum Leap Healthcare Collaborative
Iris Castro, MPH, CCRP, Data Manager, KAI Research
Lauren Rae, Manager of Clinical Data Management, PRA Health Sciences
Bryan Farrow, eClinical Catalyst, OpenClinica (panel moderator)
Well before any efficacy or safety results arrive, data managers are awash in operational data. Today’s eClinical systems provide a wealth of real-time data on processes from site activation to adverse event tracking. What practical insights for more efficient operations and better clinical data can we draw from this information? How do data managers distill those insights from reports? With whom and how should they share the results? This panel session sets out to answer these questions. Attendees will leave the session with specific KPIs for a variety of trial types, from fast-enrolling Phase IIs, where data speed is critical, to large, endpoint-driven Phase IIIs, where patient recruitment largely determines timelines. Specifically, our panel will outline KPIs for:
- Site selection and activation (e.g feasibility questionnaire completion; 1572s and CVs submission)
- Enrollment (e.g. screened per month; screen failure rates; randomized per month)
- Visit adherence (e.g. actual visits / expected visits)
- Data entry (e.g. missing vs. expected fields; expected pages missing)
- Query resolution (e.g. age bracketing; outstanding queries per site)
- Safety outcomes (e.g. how many per site? how complete is the documentation?)
- Monitoring (e.g. SDV)
The panel will recommend best practices for collecting these KPIs and communicating them to study stakeholders, including sites and monitors, for greater accountability. The panelists will also explore the benefits and limitations of data visualizations and study portals for disseminating these KPIs. Optimizing data quality, speed, and cost will form the common thread for all these related topics.
1. Understand the various domains for which KPIs ought to be developed (e.g. site selection, site activation, enrollment, data submission, safety)
2. Learn how to set achievable performance goals for a particular study based on its phase, size, therapeutic area and other attributes
3. Systemically convert reports (e.g. queries, missing forms) into dashboards that make both trends and individual site performances more conspicuous
4. Communicate performance indicators to sites and individuals in a supportive manner that maximizes their compliance with data submission and documentation
CDM Certification Competencies
1. Data Query Processing and Tracking
2. SAE Reconciliation and Safety Review
3. Data Base Quality Control Audits
Who Should Attend?
1. Data Managers
2. Clinical Research Associates
3. Clinical Trial Managers