โeSource: A Clinical Data Managerโs Tale of Three Studiesโ highlights the challenges and benefits of eSource studies, and a look to the potential future. With the continuing adoption of eClinical solutions in clinical research, the need to understand, address, and utilize the time and cost savings benefits of eSource will grow increasingly important.
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eSource: A Clinical Data Manager's Tale of Three Studies
1. Maura Bearden
Clinical Data Manager
DATATRAK International
eSource: Clinical Data Managerโs
Tale of Three Studies
2. Confidential โ
Agenda
โบ What are eSource Studies?
โบ Comfort of Paper Source Studies
โบ eSource Case Studies
โบ Challenges of eSource Studies
โบ Benefits of eSource Studies
โบ Future of eSource
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3. Confidential โ
eSource Studies
โบ 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.
โบ Why are companies moving toward
eSource studies?
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4. Confidential โ
Comfort of Paper Source Studies
โบ Familiarity of Paper Source Studies
โบ Standardization of
Paper Source Studies
โบ Security
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5. Confidential โ
eSource Case Studies
โบ Three Different eSource Studies
โบ Study 1:
โข Phase 2, 160 subjects and 24 sites
โบ Study 2:
โข Phase 3, 400 subjects and 31 sites
โบ Study 3:
โข Phase 2, 210 subjects and 20 sites
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6. Confidential โ
eSource Case Studies
โบ Analysis of three studies provides the
following information:
โข Challenges of eSource Studies
โข Benefits of eSource Studies
โข Future of eSource
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7. Confidential โ
Challenges of eSource Studies
โบ Workflow process between monitoring and
data management
โบ Protocol-Specific system checks
โบ FDA Guidelines pertaining to data
originator elements for transcribed
assessments
โบ Site Compliance of FDA Guidance of
electronic source data
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8. Confidential โ
Challenge of Workflow Process
โบ Workflow process between
monitoring and data management
โข Study: Cross-comparison of all three
studies
โข Problem: How to document the review
between monitors and data
management
โบ Solution: Additional data review flag
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9. Confidential โ
Challenges of Protocol-Specific
Checks
โบ Protocol-Specific System Checks
โข Study: Progression of all three studies
โข Problem: Number of protocol-specific system
checks
โบ Solution: Identification of integral protocol
checks, help prompts and additional
electronic case report forms (eCRFs)
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10. Confidential โ
Challenges of FDA Guidelines
โบ FDA Guidelines pertaining to data
originator elements for transcribed
assessments
โข Study: Study 3
โข Problem: Coordinator entering information
into eCRF that is being read off by PI and the
conflict with the data originator in EDC.
โบ Solution: additional review fields on eCRF
that correspond to authorized data
originator
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Challenges of FDA Guidance
โบ Site Compliance of FDA Guidance of
electronic source data
โข Study: Study 1
โข Problem: Sites writing study information on
paper
โบ Solution: Note-to-File regarding paper
sources and retraining of site
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12. Confidential โ
Benefits of eSource Studies
โบ Higher Data Integrity
โบ Real-Time Data Availability
โบ Decreased Time for Data Management
Review
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13. Confidential โ
Higher Data Integrity Benefit
โบ Higher Data Integrity
โข No queries needed to correct transcription
errors between paper source and EDC
โข 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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14. Confidential โ
Real-Time Data Availability Benefit
โบ Real-Time Data Availability
โข Allows for all information to be available at
any time
โข Reduce review time querying site to enter
information
โข Allows for real-time reports with all available
data
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Decreased Time for Data Mngt
Review
โบ Decreased Time for Data Management
Review
โข Reduced number of confirmation queries
โข Limits data management review to cross-
checks and traditional data management
reviews
โข Remote monitoring (increased importance)
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16. Confidential โ
The Future of eSource
โบ Familiarity and optimization of start-up and
workflow process of eSource studies
โข Familiarity and optimization can be seen in an
analysis of study 2 and study 3.
โDecreased study deployment time
โDistinct data review responsibilities for data
managers and monitors
โStreamlining user errors
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17. from Concept to Cure
with DATATRAK ONE
DATATRAK International
Cleveland, Ohio
Bryan, Texas
Cary, North Carolina
888.677.DATA (3282) Toll Free
www.datatrak.com
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