esource: what you need to know
DESCRIPTION
View this recorded webinar to hear an overview of the Guidance Document on Electronic Source Data in Clinical Investigations and its practical implementation.TRANSCRIPT
August 20, 2014
eSource: What You Need to Know
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Your Speakers► Maura Bearden
• Maura is a graduate of the University of North Carolina at Chapel Hill and has been with DATATRAK in a variety of Clinical Data Management roles since 2012. Ms. Bearden’s expertise is in the streamlining of study start-up tactics, data management and customer service.
► Bill Gluck, Ph.D.• Dr. Gluck has over 30 years of expertise in clinical
research, with experience in sponsors, CROs, and with DATATRAK in a variety of roles. Dr. Gluck is also the Program Director for the Clinical Trials Research and Medical Product Safety/Pharmacoviligance programs at Durham Technical Community College. Dr. Gluck earned his Bachelor of Science Degree at the University of Scranton and Master and Ph.D. degrees from North Dakota State University.
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Agenda► Key Dates in Time: eSource► Overview of the Guidance Document on
Electronic Source Data in Clinical Investigations
► Why eSource?► Practical Applications – eSource: A CDM’s
Tale of Three Studies• Challenges of eSource Studies• Benefits of eSource Studies • Future of eSource
► Summary
Dr. Bill GluckVice President Clinical Knowledge
DATATRAK International
eSource: Guidance Overview
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Genesis of eSource: Key Dates in Time
► 1968 – LL Weed, New England Journal of Medicine 278:593-600
► 1980’s-present – Evolution of IRT, EDC, ePRO/eCOA technologies
► 1997 – Regulatory definitions begin to evolve• CDISC and an industry-led standardization
movement begin► September 2013 – Guidance for Industry
on Electronic Source Data in Clinical Investigations
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Guidance Document Addresses the Following
► Identification and specification of authorized source data originators
► Creation of data element identifiers to facilitate examination of the audit trail by sponsors, FDA, and other authorized parties
► Ways to capture source data into the eCRF using either manual or electronic methods
► Clinical investigator(s) responsibilities with respect to reviewing and retaining electronic data
► Use and description of computerized systems in clinical investigations
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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 are transcribed from a paper source into EDC.
Simply put (from the Guidance Document): “Electronic source data are data initially
recorded in electronic format.”
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Data Capture: Electronic Source Data Origination
► List of authorized source data originators should be developed and maintained by the sponsor and made available at each clinical site
► Examples of Data Originators:• Clinical investigator(s) and delegated staff• Clinical investigation subjects or their legally
authorized representatives• Consulting services• Medical devices• Electronic Health Records• Automated laboratory reporting systems• Other technology
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Data Capture: Source Data Capture, Data Element Identifiers, Modifications and Corrections, and Use of Data Quality
Checks► Source Data Capture
• Direct entry of data into the eCRF• Automatic transmission of data directly into the eCRF• Transcription of data from paper or electronic sources
to the eCRF• Direct transmission of data from the EHR to the eCRF• Transmission of data from PRO instruments to the
eCRF► Data Element Identifiers► Modifications and Corrections► Use of electronic prompts, flags, data quality
checks in the eCRF
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Data Review
► Clinical Investigators• Clinical Investigator(s) review and electronic
signature• Data exempt from investigator(s) review
► Modifications and Corrections During Review of the eCRF
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Retention of Records by Clinical Investigator(s)
► Retain control of the records• Completed and signed eCRF• Certified copy of the eCRF
► Be able to provide inspectors with access to the records that serve as electronic source data
► When transcription from paper occurs – the paper is the source and must be retained
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Data Access► Viewing Data
• Sponsors, CROs DSMBs and other authorized personal can view data before and after the clinical investigator has signed the completed eCRF– Allow for early detection of study-related
problems– Missing data– Data Discrepancies
► CDMP should list individuals with authorized access to the eCRF
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Use and Description of Computerized Systems
► Adequate controls must be in place► Note: determination of whether a computer
system is suitable may not be under the control of the clinical investigator or sponsor (EHRs for example) – see 45 CRF Part 170
► Documentation – if computerized system are to be used• Protocol/CDMP/Investigational plan• Description of security measures employed to
protect the data• Description/Diagram of the electronic data flow
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Why eSource?
► Companies are reluctant to move away from paper-based source documentation• It is very familiar and is today’s standard• It is well documented and has a clear audit trail• It has well documented security measures
► eSource• Higher data integrity = Streamlined Data
Review Process• Real-time accessibility
Maura BeardenClinical Data Manager
DATATRAK International
Practical ApplicationseSource: A CDM’s Tale of Three Studies
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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
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Conclusions
► eSource has been recognized as an accepted means of capturing clinical data during clinical investigations by the FDA
► The FDA has provided guidance to industry for its implementation and use
► Case studies demonstrate the benefits of eSource trials:• Higher data integrity• Real-Time accessibility• Streamlined Data Management Review Time
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Questions
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Contact Information► Maura Bearden
• [email protected] ► Bill Gluck, Ph.D.
• [email protected]► General Questions about DATATRAK
• [email protected] ► Find Us Online
• www.DATATRAK.com• http://www.slideshare.net/DATATRAK • @DATATRAKinc on Twitter• https://
www.linkedin.com/company/datatrak-international
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