Smart Designs for Data Collection with Adaptive Clinical Trials

An On-Demand Webinar with PharPoint Research

 

When designing data collection forms, it is essential to keep the end goals in mind. Skilled database designers must consider expected data standards, data integrations, and statistical analyses. An additional challenge that database designers face is when the clinical trial has an adaptive design that alters the data collection design.

Watch this webinar as PharPoint Research, a full-service Contract Research Organization (CRO), presents examples of how they used CDASH guidance to build forms for an adaptive study and produce SDTM compliant datasets ready for analysis.

Key takeaways include:
  • Understanding how CDASH points toward SDTM
  • Learning how data collected on multiple forms is integrated into a given SDTM dataset
  • Using prompting questions and form rules to meet the adaptive design
Marilee Newman, MT ASCP
Director of Data Management, Atlantic Research Group

Marilee Newman serves as ARG’s Director of Data Management overseeing a team of Data Leads responsible for the delivery of high quality clinical databases. Marilee joined ARG in 2015 after spending 20 years at large CROs in roles inclusive of leading a DM support office and managing global portfolios for selected providers as well as acting as a Director of Clinical Services for a dedicated Sponsor. Marilee’s therapeutic experience includes ophthalmology, cardiovascular, device, post-market, diabetes, gastroenterology and CNS. She holds a BS in Medical Technology.

Michael Lange, CCRC
Data Manager and Database Startup Specialist, Atlantic Research Group

Michael serves as ARG’s Clinical Start-up Specialist and has been a member of the Data Management team since April 2016. Prior to ARG, Michael spent the last 3 years in a private practice clinical research center. Michael started his career as a Clinical Research Assistant, then moved on to a Clinical Research Coordinator position and was then promoted to Research Manager, providing leadership and guidance to support staff, Site Directors and Principal Investigators. Michael received his B.A. in English from Mary Washington College.

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