eSource: What You Need To Know


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View this recorded webinar to hear an overview of the Guidance Document on Electronic Source Data in Clinical Investigations and its practical implementation.

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  • eSource was first attributed to LL Weed:
    1 - Introduced the concept of the problem oriented medical record into medical practice
    2 - Concept allow a 3rd party to verify the diagnosis
    In the 1980’s through to the present we have been able to leverage technology using application offerings such as randomization and drug inventory, ePRO and eCOA (electronic clinical outcome assessments)
    In the latter portion of the 1990’s we started to see an industry-wide movement toward standardization. Knowing through the use of standards we would be better positioned to leverage technology and management data more efficiently. With that in 1997/1998 CDISC was formed and an industry-lead standardization movement was underway.
    In 2013 the Guidance for Industry on Electronic Source Data in Clinical Investigations was published – unlike the original draft the published guidance is a procedural guideline
  • To briefly note some of the highlights from the guidance document – the guidance document addresses each of the above items
  • In order to move forward we will define eSource data….as noted in the slide.
  • Data originators typically include the clinical investigator and the site staff – data collecting instruments and other technology-based sources
  • It is interesting to note that the FDA does not intend to assess the compliance of EHRs with Part 11
  • Pretty much do the same comparison to why use EDC over paper data collection

    Now that we have an understanding of what the FDA has provided industry from the guidance document, let’s look a how eSource has been implemented in three active clinical studies – Maura Bearden will define the types and sizes of the studies, some of the challengs faced durting the implementation process and how each challenge was overcome. Based on the preliminary data from the three studies she will also describe the benefits gains through the use of eSource and then before concluding the webinar Maura will provide some of her ideas about the future of eSource in clinical trials.
  • eSource: What You Need To Know

    1. 1. August 20, 2014 eSource: What You Need to Know
    2. 2. 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. 2
    3. 3. 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 3
    4. 4. Dr. Bill Gluck Vice President Clinical Knowledge DATATRAK International eSource: Guidance Overview
    5. 5. 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 5
    6. 6. 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 6
    7. 7. 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.” 7
    8. 8. 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 8
    9. 9. 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 9
    10. 10. 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 10
    11. 11. 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 11
    12. 12. 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 12
    13. 13. 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 13
    14. 14. 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 14
    15. 15. Maura Bearden Clinical Data Manager DATATRAK International Practical Applications eSource: A CDM’s Tale of Three Studies
    16. 16. 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 16
    17. 17. eSource Case Studies ► Analysis of three studies provides the following information: • Challenges of eSource Studies • Benefits of eSource Studies • Future of eSource 17
    18. 18. 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 18
    19. 19. 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 19
    20. 20. 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) 20
    21. 21. 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 21
    22. 22. 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 22
    23. 23. Benefits of eSource Studies ► Higher Data Integrity ► Real-Time Data Availability ► Decreased Time for Data Management Review 23
    24. 24. 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 24
    25. 25. 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 25
    26. 26. 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) 26
    27. 27. 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 27
    28. 28. 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 28
    29. 29. Questions 29
    30. 30. Contact Information ► Maura Bearden • ► Bill Gluck, Ph.D. • ► General Questions about DATATRAK • ► Find Us Online • • • @DATATRAKinc on Twitter • international 30
    31. 31. from Concept to Cure with DATATRAK ONE DATATRAK International Cleveland, Ohio Bryan, Texas Cary, North Carolina London, UK 888.677.DATA (3282) Toll Free ® ®