Maura BeardenClinical Data Manager

DATATRAK International

eSource: Clinical Data Manager’s Tale of Three Studies

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Agenda

► What are eSource Studies?► Comfort of Paper Source Studies► eSource Case Studies► Challenges of eSource Studies► Benefits of eSource Studies ► Future of eSource

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eSource Studies

► eSource studies pertain to clinical trials where direct data entry into an electronic data capture system (EDC) is used in contrast to paper source studies where data is transcribed from the paper source into EDC.

► Why are companies moving toward eSource studies?

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Comfort of Paper Source Studies

► Familiarity of Paper Source Studies► Standardization of

Paper Source Studies► Security

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eSource Case Studies

► Three Different eSource Studies ► Study 1:

• Phase 2, 160 subjects and 24 sites► Study 2:

• Phase 3, 400 subjects and 31 sites► Study 3:

• Phase 2, 210 subjects and 20 sites

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eSource Case Studies

►Analysis of three studies provides the following information:• Challenges of eSource Studies • Benefits of eSource Studies • Future of eSource

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Challenges of eSource Studies

► Workflow process between monitoring and data management

► Protocol-Specific system checks ► FDA Guidelines pertaining to data

originator elements for transcribed assessments

► Site Compliance of FDA Guidance of electronic source data

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Challenge of Workflow Process

►Workflow process between monitoring and data management • Study: Cross-comparison of all

three studies • Problem: How to document the

review between monitors and data management

►Solution: Additional data review flag

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Challenges of Protocol-Specific Checks

► Protocol-Specific System Checks• Study: Progression of all three studies • Problem: Number of protocol-specific

system checks► Solution: Identification of integral

protocol checks, help prompts and additional electronic case report forms (eCRFs)

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Challenges of FDA Guidelines

► FDA Guidelines pertaining to data originator elements for transcribed assessments • Study: Study 3• Problem: Coordinator entering information

into eCRF that is being read off by PI and the conflict with the data originator in EDC.

► Solution: additional review fields on eCRF that correspond to authorized data originator

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Challenges of FDA Guidance

► Site Compliance of FDA Guidance of electronic source data • Study: Study 1 • Problem: Sites writing study information

on paper► Solution: Note-to-File regarding paper

sources and retraining of site

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Benefits of eSource Studies

► Higher Data Integrity ► Real-Time Data Availability ► Decreased Time for Data

Management Review

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Higher Data Integrity Benefit

► Higher Data Integrity• No queries needed to correct

transcription errors between paper source and EDC

• Protocol-specific edit checks in the system and eCRF prompts prevent subjects who are not qualified from being randomized in the study

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Real-Time Data Availability Benefit

► Real-Time Data Availability• Allows for all information to be available

at any time• Reduce review time querying site to

enter information• Allows for real-time reports with all

available data

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Decreased Time for Data Mngt Review

► Decreased Time for Data Management Review• Reduced number of confirmation queries • Limits data management review to

cross-checks and traditional data management reviews

• Remote monitoring (increased importance)

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The Future of eSource

► Familiarity and optimization of start-up and workflow process of eSource studies • Familiarity and optimization can be seen

in an analysis of study 2 and study 3. –Decreased study deployment time –Distinct data review responsibilities

for data managers and monitors –Streamlining user errors

from Concept to Cure

with DATATRAK ONE

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