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Electronic Laboratory Notebooks

Electronic Laboratory Notebooks. Douglas Perry, Ph.D. IU School of Informatics. Da Vinci’s Notebook. Ca. 1500. Curie’s Notebook. Ca. 1900. Prof. X’s Notebook. Ca. 2000. Traditional Functions of Lab Notebooks. Record experimental conditions Store primary lab data

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Electronic Laboratory Notebooks

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  1. Electronic Laboratory Notebooks Douglas Perry, Ph.D. IU School of Informatics

  2. Da Vinci’s Notebook • Ca. 1500

  3. Curie’s Notebook • Ca. 1900

  4. Prof. X’s Notebook • Ca. 2000

  5. Traditional Functions of Lab Notebooks • Record experimental conditions • Store primary lab data • Note experimental observations • Give references to external data • Make interpretations • Draw conclusions • Provide legal record for intellectual property

  6. Data vs. Metadata • Data • Raw data • Processed data • Final results • Metadata • Test conditions • Methods & SOPs • Personnel

  7. Paper-Based Information is Limited • Hard to use • Making entries is slow, tedious • Hard to reuse • Protocols, repetitive information dropped • Easily lost • Unique documents mislaid, forgotten • Hard to search • Poor indexing, keywords, table of contents • Hard to share • Copying difficult or not legal

  8. Paper Lab Notebooks Are Becoming Obsolete • Paper notebooks have limited capacity • Raw data is massive • Data capture is archaic • Raw printouts can no longer be stored • Data formats are restricted • 2-D gels, photomicrographs • Record-keeping is tedious • Repetitive, manual entries • Context of work is often lost • No connection to other people, projects, labs • Paper records no longer legally required • Electronic records are legal

  9. “Closed” Notebooks Are Often Needed Source: Collaborative Electronic Notebook Systems Association

  10. Time Spent on Data Housekeeping • Lab personnel spend >16 hr/wk managing data • Lab managers spend up to 8 hr/wk trying to find data • Proprietary information workers spend 8 hr/wk auditing notebooks Source: Collaborative Electronic Notebook Systems Association

  11. Data Flow in the Laboratory Data Analysis Lab Automation & Robotics Chromatography Data Systems Data Warehousing Electronic Laboratory Notebooks Equipment Interfacing Laboratory Information Management Systems (LIMS) Data Mining Laboratory Instruments Data Acquisition Information Processing Knowledge Management

  12. Data Warehousing Data Mining/ Data Analysis Electronic Laboratory Notebook LIMS DBMS Local Laboratory Network Instrument Data Manager PC Chromatography Data System Instrument Network Manual Data Entry SC GC LC GC SP F AB Scientific DataManagement Architecture

  13. PRODUCTION LAB RESEARCH LAB ELN Is Complementary to LIMS ELN LIMS Source: Amphora Research Systems

  14. Functional Hierarchy in Laboratory Informatics SDMS, ELN knowledge rules people CDS, LIMS information rules context DAQ, LAB AUTO data

  15. Paper vs. ElectronicLaboratory Notebooks • Paper • Static, limited format • Passive record keeping • Can meet all legal and regulatory requirements • Electronic • Dynamic, multiple formats • Active collaboration • Can meet all legal and regulatory requirements

  16. Paper Notebooks Vs. Knowledge Management • Knowledge is individual, not collective • Journal paradigm fosters “private” mentality • Limited collaboration with other labs, other locations • “Sharing” consists of old summaries • Difficult to supervise scientific progress of others • No easy to evaluate other’s experiments • Methods must be reinvented or reoptimized • Metadata not recorded or not traceable • Reevaluation of old data impossible • Raw data of “poor” results not kept

  17. Unique Benefits of ELN • Integrates heterogeneous data from disparate sources • Fully searchable beyond keywords and indices • Drill-down access to raw data • Secure access from any computer • On-the-fly analysis and feedback

  18. New Demand for ELN:21 CFR part 11 • FDA rule initiated August 1997 • Sets standards for electronic submission • Electronic records • Thoroughly validated • Automatic audit trails • Results can be recreated • Electronic signatures • Unique identity • Linked to e-record • No grandfather clause

  19. eRecord Defined “An electronic record is any combination of text, graphics, data, audio, pictorial, or other information represented in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.” --21 CFR part 11.3 (b)(6)

  20. eSignature Defined “An electronic signature is a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature.” --21 CFR part 11.3(b)(7)

  21. Electronic Authoring, Review, and Approval Null or current approved version New approved version Author Reviewer Authorizer ES AUTHORINGPROCESS REVIEW & APPROVALPROCESS

  22. Those Who Benefitfrom ELN • Scientists • Data analysis, not data management • Lab managers • Data management, not notebook management • Compliance officers • Complete audit trails with no paper chase • QA/QC directors • Concurrent accessibility of all data • Corporate attorneys • Complete, legal records for litigation support

  23. Concerns about ELN • Major change imposition • Restructuring of scientists’ core activities • Loss of privacy • Notebook is transformed from a personal journal to a community center • Loss of control • Data and metadata could be altered by others • Corporate imposition • Roll-out by executive fiat, not individual adoption

  24. Cost vs. Value forLaboratory Notebooks

  25. ELN Impact Study Source: Trigg J and Davis S: Transforming the Laboratory by Implementing an Electronic Laboratory Notebook, Managing the Modern Laboratory, 5:4, 2001

  26. ELECTRONIC LABORATORY NOTEBOOK Collaborative ELN research specialist nurse clinician data encoder scientist lab technician writer lab manager statistician

  27. scientist clinician lab manager research specialist lab technician data encoder Stratified Collaboration Using ELN Knowledge Information Data

  28. CENSA Collaborative Electronic Notebook Systems Association

  29. ELN Functionality Examples from Kalabie™ and LABTrack ™

  30. Experiment Entry

  31. Experiment Management

  32. Experiment Review

  33. Making Page Entries

  34. Revising Page Entries

  35. Embedding Graphics

  36. Notarizing a Page

  37. Maintaining an Audit Trail

  38. Searching the Notebook

  39. Kodak UK Programs & Projects General access from Lotus Notes ELN ELN ELN MRP Lotus Notes ELN Analytical Support for R&D Programmes through ELN Mfg Problem Solving databases Summary Database Reports Database Walk Up LIMS Reference Data Data Acquisition Walk Up services for Analytical clients Instrument interfaces for direct transmission of data to LIMS

  40. A True Story…

  41. The Loss… • One month of work by postdoc • $3,000 in labor and supplies • Protocol to replicate experiments

  42. The Consequences… • In effect, experiments had never been done • No preliminary data for NIH grant application • No supporting data for related publication

  43. The Moral… • ELN is needed as much in academia as it is in industry

  44. Questions & Comments

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