Maura Bearden
Clinical Data Manager
DATATRAK International
eSource: Clinical Data Manager’s
Tale of Three Studies
Confidential –
Agenda
► What are eSource Studies?
► Comfort of Paper Source Studies
► eSource Case Studies
► Challenges of...
Confidential –
eSource Studies
► eSource studies pertain to clinical trials
where direct data entry into an electronic
dat...
Confidential –
Comfort of Paper Source Studies
► Familiarity of Paper Source Studies
► Standardization of
Paper Source Stu...
Confidential –
eSource Case Studies
► Three Different eSource Studies
► Study 1:
• Phase 2, 160 subjects and 24 sites
► St...
Confidential –
eSource Case Studies
► Analysis of three studies provides the
following information:
• Challenges of eSourc...
Confidential –
Challenges of eSource Studies
► Workflow process between monitoring and
data management
► Protocol-Specific...
Confidential –
Challenge of Workflow Process
► Workflow process between
monitoring and data management
• Study: Cross-comp...
Confidential –
Challenges of Protocol-Specific
Checks
► Protocol-Specific System Checks
• Study: Progression of all three ...
Confidential –
Challenges of FDA Guidelines
► FDA Guidelines pertaining to data
originator elements for transcribed
assess...
Confidential –
Challenges of FDA Guidance
► Site Compliance of FDA Guidance of
electronic source data
• Study: Study 1
• P...
Confidential –
Benefits of eSource Studies
► Higher Data Integrity
► Real-Time Data Availability
► Decreased Time for Data...
Confidential –
Higher Data Integrity Benefit
► Higher Data Integrity
• No queries needed to correct transcription
errors b...
Confidential –
Real-Time Data Availability Benefit
► Real-Time Data Availability
• Allows for all information to be availa...
Confidential –
Decreased Time for Data Mngt
Review
► Decreased Time for Data Management
Review
• Reduced number of confirm...
Confidential –
The Future of eSource
► Familiarity and optimization of start-up and
workflow process of eSource studies
• ...
from Concept to Cure
with DATATRAK ONE
DATATRAK International
Cleveland, Ohio
Bryan, Texas
Cary, North Carolina
888.677.DA...
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eSource: A Clinical Data Manager's Tale of Three Studies

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‘eSource: A Clinical Data Manager’s Tale of Three Studies’ 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. 1. Maura Bearden Clinical Data Manager DATATRAK International eSource: Clinical Data Manager’s Tale of Three Studies
  2. 2. Confidential – Agenda ► What are eSource Studies? ► Comfort of Paper Source Studies ► eSource Case Studies ► Challenges of eSource Studies ► Benefits of eSource Studies ► Future of eSource 2
  3. 3. Confidential – 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? 3
  4. 4. Confidential – Comfort of Paper Source Studies ► Familiarity of Paper Source Studies ► Standardization of Paper Source Studies ► Security 4
  5. 5. Confidential – 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 5
  6. 6. Confidential – eSource Case Studies ► Analysis of three studies provides the following information: • Challenges of eSource Studies • Benefits of eSource Studies • Future of eSource 6
  7. 7. Confidential – 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 7
  8. 8. Confidential – 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 8
  9. 9. Confidential – 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) 9
  10. 10. Confidential – 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 10
  11. 11. Confidential – 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 11
  12. 12. Confidential – Benefits of eSource Studies ► Higher Data Integrity ► Real-Time Data Availability ► Decreased Time for Data Management Review 12
  13. 13. Confidential – 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 13
  14. 14. Confidential – 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 14
  15. 15. Confidential – 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) 15
  16. 16. Confidential – 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 16
  17. 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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