With this approach, SDTM conversions can be done as soon as patient data is collected.
TORONTO (PRWEB)
November 17, 2022
Since the FDA passed regulations requiring submitted datasets to be compliant with the CDISC Study Data Tabulation Model (SDTM), clinical trial sponsors have faced a dilemma. Should they design electronic case report forms (eCRFs) in line with SDTM from the outset? Or should they retrospectively convert data to CDISC SDTM at the end?
A retrospective approach is fraught with risk. What if some of the required data is missing? Will it be possible to retrofit datasets and terminology into the CDISC SDTM and NCI Controlled Terminology models? Will the submission be compliant?
This time-consuming data wrangling distracts resources from the important business of delivering a high quality submission package – before the deadline!
In this presentation, we discuss a ‘designing with the end in mind’ approach. This includes: Designing optimal data collection eCRFs which balance ease of data collection whilst aligning to SDTM and NCI CT requirements; And designing target SDTM datasets and mapping these to raw datasets upfront.
The big win?
With this approach, SDTM conversions can be done as soon as patient data is collected. Plus, conversions can be run throughout the trial, allowing clinicians to analyze and visualize data immediately, and make timely safety and efficacy decisions.
Now continuous quality monitoring during a study is possible. Coupled with the benefits of early data visibility, this will speed therapies to market faster than ever before.
Register for this webinar and hear from leading industry experts about designing studies with the end in mind — and how technology can be leveraged to facilitate this.
Join Scott Robertson, Vice President Sales, Global Partnerships, Mednet; Mark Wheeldon, CEO, Formedix; and Ed Chappell, Solutions Consultant, Formedix, for the live webinar on Thursday, December 01, 2022, at 1pm EST (10am PST).
For more information, or to register for this event, visit How To Accelerate & Improve the Quality of CDISC SDTM Deliverables: Design with the End in Mind.
ABOUT XTALKS
Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year, thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.
To learn more about Xtalks visit http://xtalks.com
For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/
Contact:
Vera Kovacevic
Tel: +1 (416) 977-6555 x371
Email: vkovacevic@xtalks.com
Share article on social media or email: