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.
- 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.
Mark Wheeldon, CEO, Formedix
Mark Wheeldon is the Founder and CEO of Formedix. He is an active supporter of the Clinical Data Interchange Standards Consortium (CDISC) which Formedix has been a member of since its inception two decades ago. Mark is a member of the CDISC Industry Advisory Council (CAC), and strongly believes that a more efficient end-to-end clinical trial process lies in the successful implementation of data standards and clinical trial automation technologies.
Ed Chappell, Solutions Consultant, Formedix
Ed Chappell has been working as a Solutions Consultant with Formedix for over 13 years. He has authored and now presents Formedix’s training courses for SEND, SDTM, Define-XML, ODM-XML, Define-XML and Dataset-XML. Ed was heavily involved in the development of the ryze dataset mapper and works closely with customers on SDTM dataset mapping. As an expert in clinical data programming, Ed also supports customers with Interim Analysis (IA) SDTM and the US Food and Drug Administration (FDA) SDTM clinical trial submissions.
Martin Johnston, Solutions Consultant, Formedix
Martin has been working as a Solutions Consultant with Formedix for over 3 years. He works closely with Formedix ryze clients, providing daily support with clinical study builds. Martin delivers training on Define-XML, in particular the building of defines, as well as SDTM mappings. Essentially, Martin is an expert in the end-to-end ryze platform and his mission is to help our customers maximize the benefits they can achieve from ryze.
Jenny Erasmus, Sr. Director of Marketing, Mednet
Jenny Erasmus is Sr. Director of Marketing, representing the Mednet partner team. Mednet is a healthcare technology company specializing in eClinical solutions designed for the global life sciences community. Mednet partners with organizations around the world with building and executing all types of clinical research. Their partner, product and project management teams provide exceptional strategic counsel and are highly trained and experienced in building studies of all types in the iMednet platform.
Who Should Attend?
This webinar will benefit those responsible for or involved in the selection of a clinical metadata repository. It will also benefit those looking to introduce standardization into their clinical trial design and build process. This includes people working on data standards, data management, regulatory compliance (including CDISC) and governance in pharmas, biotechs, CROs, universities and medical device organizations, including:
- Regulatory Affairs
- Clinical Operations
- Clinical Affairs
- Project Management
What You Will Learn
In this webinar, attendees will learn:
- Why the Clinical Data Acquisition Standards Harmonization (CDASH) design upfront is beneficial
- How to avoid delays in trial submission
- The benefits of aligning with the Clinical Data Interchange Standards Consortium (CDISC) from study design
- How technology supports compliant study design and build
- How technology enables earlier Study Data Tabulation Model (SDTM) conversions and faster access to data
Want to design and build clinical trials faster with less effort? Now you can, with our new clinical metadata repository (CMDR) and automation cloud platform, ryze. We’ve automated manual, labor-intensive processes, and given you the tools to standardize study build and integrate 3rd party platforms.
Simply house your standards and study library in the central MDR, then easily find, manage, and reuse content. Even import content from EDCs and e-clinical systems into ryze. You can design studies for leading EDCs – and see exactly how forms look in ryze without having to build your study.
Instantly convert datasets to SDTM, and make submission deliverables with the click of a button. And all effortlessly in line with CDISC standards. ryze is built on CDISC compliant templates, so compliance is enforced throughout study build. Plus, ryze is a cloud-based off-the-shelf suite, so there’s zero install and it’s ready to go when you are!