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Maximizing the Potential of Your EDC System

Track:
Processes and Technologies for Clinical Research

Day & Time:
June 18, 10:30AM - 12:00PM (Pacific Standard Time)

Session Number:
335

Room Number:
30CD

Level:
Intermediate

Type:
Symposium

Title:
Maximizing the Potential of Your EDC System

Chair(s):
Maryanne C. Nicosia, MS
Director, Clinical Data Management
Neurocrine Biosciences Inc., United States

Description:
Electronic data capture (EDC) is not a new technology, but many organizations are not realizing the expected efficiencies and full potential of their chosen EDC system. This symposium will provide ideas on how organizations can enhance efficiency and reduce overhead through a unique approach to electronic case report form (eCRF) creation. Attendees will also learn how an EDC workflow that uses a continuous review and lock process can help enable study go/no-go decisions to be made before unnecessary time and money have been spent collecting and cleaning data. Attendees will hear how to effectively handle rescue studies and EDC data from multiple EDC systems so that final datasets are consistent no matter where or how the data was collected.


Learning Objective(s):
Articulate the benefits of building and reviewing an electronic case report form (eCRF) outside the traditional study visit structure; Explain the advantages of collecting the critical data points in order to reduce queries and times spent on data cleaning; Identify how an electronic data capture (EDC) workflow that utilizes continuous review and locking can assist with mid-study decisions and faster database lock; Discuss the complexities of and solutions for managing an EDC rescue study.

Presentation(s) & Speaker(s):
Enhancing Efficiency, Reducing Overheard Through a New Approach to eCRF Creation
Gill Hallett, MS
Director of Project Consultancy
Datatrial, United Kingdom

Achieving the Full Potential of EDC Through Efficient Workflows
Simon Wilson
Subject Matter Expert, Clinical
ArisGlobal, United Kingdom

EDC Rescue Studies: Combining Multiple Datasets to Meet Reporting Requirements
Carmen Weese
Senior Vice President, Data Operations
INC Research, United States