Pre-Conference
Workshops
Sunday, October 8, 2023
Starting at 8 AM
#SCDM23 is proud to present a series of engaging and interactive Pre-Conference Workshops designed to take your CDM skills to the next level. Delivered by industry experts, these sessions are specifically crafted to provide you with practical, actionable strategies that you can implement in your day-to-day job.
Whether you choose between our dynamic 2-hour workshops or our immersive 4-hour workshops, you will equip yourself with the practical knowledge necessary to excel in your career.
#SCDM23 is proud to present a series of engaging and interactive Pre-Conference Workshops designed to take your CDM skills to the next level. Delivered by industry experts, these sessions are specifically crafted to provide you with practical, actionable strategies that you can implement in your day-to-day job.
Whether you choose between our dynamic 2-hour workshops or our immersive 4-hour workshops, you will equip yourself with the practical knowledge necessary to excel in your career.
Discover the #SCDM23 workshops
Anthony Chow & Amy Palmer of CDISC
Hands-On with the CDISC CORE: An Immersive Exploration of Creating Machine-Executable Conformance Rules for Your Organization
Oct 8, 8.00am – 10.00am
Do you wish to be able to define and run your own rules, rules that are unique to the therapeutic area or study? CDISC conformance rules are crucial to the proper implementation of Foundational Standards in clinical studies, ensuring submission-ready data and maintaining data quality across various exchange scenarios. Join experts from CDISC for a Hands-on Workshop where you will learn how develop machine-executable conformance rules using CDISC CORE.
Chuck Dennis & Akash Trivedi of Accenture
Leveraging Industry Standards to Enable Digital Data Flow, Automate Study Startup, and Accelerate Clinical Development
Oct 8, 8.00am – 12.15pm
The drug development process is highly manual and requires repetitive data entry across various systems in various formats. Over the past two years, a collaboration between TransCelerate’s Digital Data Flow initiative and CDISC has created the new Unified Study Definitions Model (USDM) to provide an industry standard for digitizing the protocol and automating study startup. The goal of this SCDM workshop is to help attendees understand what the Digital Data Flow initiative is, learn about the CDISC USDM model, and discuss use cases that would help data managers and the clinical development process.
Dan Crawford of Veeva & Kenneth Stoltzfus of ICON
Data Requirements for an FDA Submission
Oct 8, 1.00pm – 5.30pm
This workshop will provide an overview of the requirements for submitting standardized electronic data and documents to Regulatory authorities (FDA). We will also highlight some of the tools the FDA uses to facilitate their review and their approach to reviewing the safety and efficacy portions of a submission.
Sina Adibi & Mitch Collins of Adaptive Clinical
Planning and Implementation of an Integration Hub for Clinical Data
Oct 8, 1.00pm – 3.30pm
The need for use of a clinical data integration hub has become increasingly important as our studies get more complicated, sites become hybrid and use of IoT becomes the norm. Significant planning goes into the successful setup and configuration of an integration hub for clinical data. In this workshop, participants will perform all the preparatory tasks for effective setup of an integration hub utilizing next generation technologies. The live system will include specific EMR to EDC and Biomarkers to EDC guided tours.
Lisa Lyons of Janssen & Sujata Aiyangar of Accenture