eSource: Data Capture Simplified - Uncover Time and Cost Saving Possibilities
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- eSource refers to directly capturing clinical trial data electronically at its source rather than transcribing from paper. The FDA has issued guidance on eSource. - Three case studies of eSource clinical trials found that it led to higher data integrity, real-time data accessibility, and more streamlined data review compared to paper. However, defining protocol-specific checks and ensuring compliance with FDA guidelines on data originators were challenges. - With optimization of workflows and familiarity over time, the benefits of eSource are realized through decreased study initiation times and impacts on remote monitoring.
eSource: Data Capture Simplified - Uncover Time and Cost Saving Possibilities
- 1. May 5, 2015 William Gluck, PhD, VP Clinical Knowledge Program Director CTRA and MSP Programs - Durham Technical Community College eSOURCE: Data Capture Simplified – Uncover Time and Cost Saving Possibilities
- 2. Agenda 1. Streamlining Data Capture in Clinical Trials 2. eSource Guidance Overview 3. Practical Applications – A Tale of Three Studies
- 3. Indulge Me – A Brief Walk Down Memory Lane
- 4. Ah…the good old days…..
- 5. The Dawn of Remote Data Entry….. and Dial-up
- 6. Electronic Data Capture = Change!!
- 7. Today……. ► Technology seems to advance faster than we can keep up ► EDC has been accepted industry-wide • Success driven by technology and process optimization ► We can still improve…..optimize…..build the better mousetrap!
- 8. How Do We Optimize Data Capture? Start at the Source
- 10. Conceptually - What is eSource? Simply put (from the Guidance Document): “Electronic source data are data initially recorded in electronic format.” 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.
- 11. 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
- 12. Associated Guidance Documents/Regulations ► FDA Guidance Document: Computerized Systems Used in Clinical Investigations ► FDA Regulations on Electronic Records and Electronic Signatures (see 21 CFR Part 11)
- 13. Definitions ► Electronic Record: any combination of text, graphics, data, audio, pictorial, or any other information represented in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system (21 CFR 11(.3(b)(6)) An eCRF is an example of an electronic record ► Source Data: all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical investigation used for reconstructing and evaluating the investigation ( 21 CFR 312.62(b), ICH E6)
- 14. Why eSource? – Potential benefits Capturing data via eSource and transmitting it to the eCRF should: • Eliminate unnecessary duplication of data • Reduce transcription errors • Encourage entering source data at a subject visit • Eliminate transcription of source data prior to eCRF data entry • Facilitate remote monitoring of data • Promote real time access for data review • Facilitate the collection of accurate and compete data
- 15. Data Capture: Electronic Source Data Origination ► Security and Integrity: 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
- 16. What are We Capturing? Data element – represents the smallest unit of observation captured for a subject in a clinical investigation
- 17. 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 EMRs/EHRs to the eCRF • Transmission of data from PRO instruments to the eCRF
- 18. Data Element Identifiers, Modifications and Corrections, and Use of Data Quality Checks ► Data Element Identifiers • Originators of the data element • Date and time of the element • Clinical investigation subjects to which the element belongs ► Modifications and Corrections ► Use of electronic prompts, flags, data quality checks in the eCRF
- 19. 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
- 20. 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
- 21. 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
- 22. 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 systems are to be used • Protocol/CDMP/Investigational plan • Description of security measures employed to protect the data • Description/Diagram of the electronic data flow
- 23. Practical Application of the Guidance
- 24. 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
- 25. 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
- 26. eSource Case Studies The three studies provided insights into: 1. Challenges initiating eSource Studies 2. Benefits realized from the eSource Studies 3. A view of the future of eSource
- 27. Challenges of the eSource Studies ► Workflow process at the site and between monitoring and data management groups ► Defining protocol-specific system checks ► Understanding and ensuring compliance to the FDA guidelines pertaining to data originator elements for transcribed assessments ► Training the site staffs and monitors to ensure compliance to the guidance
- 28. Challenges of Workflow Process Workflow process at the sites and between monitoring and data management • Study: Cross-comparison of all three studies • Problem #1: How to adapt site workflows for eSource data capture • Solution #1: Comprehensive review of site practices and workflow and taking a holistic approach to defining a ‘whole- study’ an educational and workflow
- 29. Challenges of Workflow Process Workflow process at the sites and between monitoring and data management • Study: Cross-comparison of all three studies • Problem #2: How to document the review between monitors and data management • Solution #2: Modify the EDC application
- 30. Challenges of Protocol-Specific Checks Defining 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)
- 31. 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
- 32. 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
- 33. Realized Benefits of eSource Studies ► Higher Data Integrity (fewer auto and manual queries) ► Real-Time Data Availability (rapid entry and access) ► Increased Throughput at All Levels for Data Review
- 34. Some Comments on the Future of eSource ►Similar to the history of EDC • eSource requires a learning curve • With familiarity and optimization of workflows, study initiation time decreases and study benefits become realized ►Not all studies are optimized for eSource….yet ►Impacts Remote Monitoring and RBM ►EMR/EHR’s will continue to impact eSource studies
- 35. Conclusions 1. eSource has been recognized as an accepted means of capturing clinical data during clinical investigations by the FDA 2. The FDA has provided guidance to industry for its implementation and use 3. Case studies demonstrate the benefits of incorporating eSource as part of the data collection/capture plan: • Higher data integrity • Real-Time accessibility • Streamlined Data Review and Accessibility
- 36. Questions