The document discusses the advantages of implementing an electronic lab notebook (ELN) system, including improved productivity, efficiency, and information management. It also addresses the importance of integrating the ELN with other informatics solutions and examines whether a "paperless lab" is attainable. Key challenges include functionality, long-term data preservation, legal and regulatory considerations, and user adoption.

1. Starting From Scratch: The ELN Reality John Trigg phaseFour Informatics Limited www.phasefour-informatics.com

2. Starting From Scratch: The ELN Reality The advantages of going electronic and implementing an ELN system The importance of integrating this with other informatics solutions Is the “paperless lab” a truly attainable goal?

3. Paperless? What do you mean by paperless? No more paper? or Paper is not the archive medium? Going paperless - the question is when, not if.

4. The advantages of going electronic and implementing an ELN system Improved productivity Greater efficiency Improved information/knowledge management Better IP protection Better patent evidence creation Happier scientists?

5. Who cares about Lab Notebooks? Lawyer Compliance Manager Lab Manager Finance Manager IP/Records Manager Scientist “ What exactly is an ELN and how will it help me? ” “ Will a court accept electronic records as evidence? ” “ Will an ELN comply with regulatory guidelines? ” “ How much is this going to cost, and what ’ s the ROI? ” “ Will we still be able to access our records in 50 years time? ” “ You want me to write-up my experiments where???? ”

6. The Case for an ELN The Benefits Easier to share Accessible knowledge repository Improved R&D productivity By eliminating some mindless paper-based processes Re-use of information The Costs Evaluation & Decision Making Development Configuration Implementation Training Hardware Software Maintenance Everything is based around one fundamental question: What is the problem you are trying to solve? The Barriers Functionality Legal/Patent/Regulatory considerations Electronic records management Long term data preservation User adoption Costs

7. The Benefits – from case studies Organisations that have implemented an ELN claim to be making time savings in the order of 10 - 15%. Improvement in operational efficiency ~20% Improvements in personal productivity Anecdotal evidence points to additional, non-quantifiable benefits. More time in the lab Easier write-ups Improved IP protection Searchable archive Increased efficiency Improved data quality Smooth transition when people leave the Company Use in informal meetings

8. The Barriers Addressing the required functionality (what is the problem you are trying to solve?) Legal/Patent/Regulatory considerations Long term data preservation Electronic records management User adoption Costs

9. What is an Electronic Lab Notebook? Scientific Requirements Scientific Data Management Discipline-specific systems Experimental design Laboratory Automation LIMS Documentation of Experiments Electronic Record Keeping Patent Evidence Creation Evidence of Regulatory Compliance Document Management Definition of an ELN (CENSA*) “ A system to create, store, retrieve, and share fully electronic records in ways that meet all legal, regulatory, technical and scientific requirements. ” * Collaborative Electronic Notebook Systems Association Definition of an ELN (Atrium Research) “ An ELN is a secure system that assembles content from multiple sources that are related to each other, allows for contextual annotation, and packages it in a legally acceptable document which can be searched, mined and collaborated. ” Is this an Electronic Lab Notebook or an Electronic Lab?

10. Functionality (& user requirements) Generic functions Support a wide variety of work across a company Enables collaboration & Knowledge Management Best achieved by deploying a “ Thin ” layer over other systems Discipline-specific functions Support for each individual scientific discipline or technology Can involve significant product & implementation costs But delivers significant productivity benefits Keep it simple Users are notoriously bad at telling what they need.

11. Are electronic records admissible? Records are not automatically admitted Admissibility governed by Federal Rules of Evidence Relevant Reliable record of events being examined Created contemporaneously with events Accurate representation. Authenticated as to their source Testimony of a qualified witness, either present at the time of creation or the custodian. March 10 1998, Official Gazette Admissibility of electronic records in interferences: Pursuant to 37 CFR 1.671, electronic records are admissible as evidence in interferences before the Board of Patent Appeals and Interferences to the same extent that electronic records are admissible under the Federal Rules of Evidence. The weight to be given any particular record necessarily must be determined on a case-by-case basis. U.S. Constitution - Article 1 Section 8 To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.

12. Long Term Data Preservation File format Standards, or lack of them Open vs. Proprietary Media Long term media life unproven/questionable CDs – 5-100yrs Magnetic Tape – 10-30yrs Application How long will current applications be available or supported? Device How long will current hardware and operating systems be available or supported?

13. Technology Adoption Life Cycle Ref : ‘Crossing The Chasm’, G.A.Moore, Capstone Publishing Technology Enthusiasts Looking for some neat technology Innovators Early Adopters Early Majority Laggards Late Majority The Chasm Visionaries Looking for a breakthrough Pragmatists Looking for an improvement Conservatives Believe in tradition Sceptics Not looking!

14. Technology Acceptance Model Davis, F.D. “A Technology Acceptance Model for Empirically Testing New End-User Information Systems: Theory and Results”, in MIT Sloan School of Management . Cambridge, MA; MIT School of Management. 1986. Perceived Usefulness Behavioural Intention External Variables Actual Use Perceived Ease of Use Attitude Toward The degree to which a person believes that using a particular system would enhance his or her job performance. The degree to which a person believes that using a particular system would be free from effort. Individual user’s positive or negative feelings about performing the target behaviour A measure of the strength of one’s intention to perform a specific behaviour.

15. Technology Adoption S-curve and the Assimilation Gap Time % User Adoption Contact Awareness Understanding Trial Use Adoption Internalisation Institutionalisation Acquisition Assimilation Gap Robert G. Fichman, Chris F. Kemerer, “The Illusory Diffusion of Innovation : An Examination Of Assimilation Gaps”, Working Paper Series No.746, Katz Graduate School of Business, University of Pittsburgh, November 1995. People are more likely to comply with a request when: A reason is provided There is give and take They see others complying The request comes from someone they respect or like The request comes from a legitimate source of authority Deployment

16. Costs – Paper vs. Electronic Paper Electronic

17. Success by Project Size – Small is beautiful! Standish Group International (1999)

18. Integration Education User Community Commitment Standards – file format and messaging / interconnect Modular Components Stable Operating System Environment Joe Liscouski : Integration in Laboratory Automation & Informatics http://theintegratedlab.com/integration-in-laboratory-automation-informatics/

19. Collaboration The rest of the world has Plug & Play – we have Plug & Pray. Use of social networking tools (as an ELN) are being explored, mainly in academia. General IT trends are towards web services, Software as a Service (SaaS).Open Source. Gartner, the technology forecasting agency, predicts that “ online social networking will come to be regarded as just the latest expression of a long-standing pattern of human behaviors that involves an increasing range of communications protocols and technologies. How to apply this in a corporate environment will be the next major challenge. ”

20. Summary Is there an advantage of going electronic and implementing an ELN system Yes, it’s a case of ‘when’, not ‘if’. Is integrating the ELN with other informatics solutions is important. Yes, but it is the most challenging area. Is the “paperless lab” a truly attainable goal? Yes (subject to what you mean by paperless).