Electronic Electronic Laboratory Laboratory NotebooksNotebooks

Douglas Perry, Ph.D.Douglas Perry, Ph.D.

IU School of InformaticsIU School of Informatics

22

Da Vinci’s NotebookDa Vinci’s Notebook Ca. 1500Ca. 1500

33

Curie’s NotebookCurie’s Notebook Ca. 1900Ca. 1900

44

Prof. X’s NotebookProf. X’s Notebook

Ca. 2000Ca. 2000

55

Traditional Functions of Traditional Functions of Lab NotebooksLab Notebooks

Record experimental conditionsRecord experimental conditions Store primary lab dataStore primary lab data Note experimental observationsNote experimental observations Give references to external dataGive references to external data Make interpretationsMake interpretations Draw conclusionsDraw conclusions Provide legal record for intellectual propertyProvide legal record for intellectual property

66

Data vs. MetadataData vs. Metadata

DataData Raw dataRaw data Processed dataProcessed data Final resultsFinal results

MetadataMetadata Test conditionsTest conditions Methods & SOPsMethods & SOPs PersonnelPersonnel

77

Paper-Based Information Paper-Based Information is Limitedis Limited

Hard to useHard to use Making entries is slow, tediousMaking entries is slow, tedious

Hard to reuseHard to reuse Protocols, repetitive information droppedProtocols, repetitive information dropped

Easily lostEasily lost Unique documents mislaid, forgottenUnique documents mislaid, forgotten

Hard to searchHard to search Poor indexing, keywords, table of contentsPoor indexing, keywords, table of contents

Hard to shareHard to share Copying difficult or not legalCopying difficult or not legal

88

Paper Lab Notebooks Are Paper Lab Notebooks Are Becoming ObsoleteBecoming Obsolete

Paper notebooks have limited capacityPaper notebooks have limited capacity Raw data is massiveRaw data is massive

Data capture is archaicData capture is archaic Raw printouts can no longer be storedRaw printouts can no longer be stored

Data formats are restrictedData formats are restricted 2-D gels, photomicrographs2-D gels, photomicrographs

Record-keeping is tediousRecord-keeping is tedious Repetitive, manual entriesRepetitive, manual entries

Context of work is often lostContext of work is often lost No connection to other people, projects, labsNo connection to other people, projects, labs

Paper records no longer legally requiredPaper records no longer legally required Electronic records are legalElectronic records are legal

99

““Closed” Notebooks Are Closed” Notebooks Are Often NeededOften Needed

0 10 20 30 40

Never

Yearly

Monthly

Weekly

Daily

Percent responding

Source: Collaborative Electronic Notebook Systems Association

1010

Time Spent on Data Time Spent on Data HousekeepingHousekeeping

Lab personnel spend >16 hr/wk Lab personnel spend >16 hr/wk managing datamanaging data

Lab managers spend up to 8 hr/wk Lab managers spend up to 8 hr/wk trying to trying to findfind data data

Proprietary information workers spend Proprietary information workers spend 8 hr/wk auditing notebooks8 hr/wk auditing notebooks

Source: Collaborative Electronic Notebook Systems Association

1111

Data Flow in the LaboratoryData Flow in the Laboratory

Lab Automation& Robotics

EquipmentInterfacing

LaboratoryInstruments

ChromatographyData Systems

Laboratory InformationManagement

Systems (LIMS)

DataAnalysis

DataMining

DataWarehousing

ElectronicLaboratoryNotebooks

Data Acquisition Information Processing Knowledge Management

1212

Scientific DataScientific DataManagement ArchitectureManagement Architecture

DBMS LIMS

Instrument Network

Local Laboratory Network

ABFSP

InstrumentData Manager

ManualData EntryGC LC

Chromatography Data System

GCSC

PC

DataWarehousing

ElectronicLaboratoryNotebook

Data Mining/Data Analysis

1313

ELN Is Complementary to ELN Is Complementary to LIMSLIMS

Source: Amphora Research Systems

1414

Functional Hierarchy in Functional Hierarchy in Laboratory InformaticsLaboratory Informatics

rules

rules

context

people

SDMS, ELN

DAQ, LAB AUTO

CDS, LIMS

1515

Paper vs. ElectronicPaper vs. ElectronicLaboratory NotebooksLaboratory Notebooks

PaperPaper Static, limited formatStatic, limited format Passive record keepingPassive record keeping Can meet all legal and regulatory requirementsCan meet all legal and regulatory requirements

ElectronicElectronic Dynamic, multiple formatsDynamic, multiple formats Active collaborationActive collaboration Can meet all legal and regulatory requirementsCan meet all legal and regulatory requirements

1616

Paper Notebooks Vs. Paper Notebooks Vs. Knowledge ManagementKnowledge Management

Knowledge is individual, not collectiveKnowledge is individual, not collective Journal paradigm fosters “private” mentalityJournal paradigm fosters “private” mentality

Limited collaboration with other labs, other locationsLimited collaboration with other labs, other locations ““Sharing” consists of old summariesSharing” consists of old summaries

Difficult to supervise scientific progress of othersDifficult to supervise scientific progress of others No easy to evaluate other’s experimentsNo easy to evaluate other’s experiments

Methods must be reinvented or reoptimizedMethods must be reinvented or reoptimized Metadata not recorded or not traceableMetadata not recorded or not traceable

Reevaluation of old data impossibleReevaluation of old data impossible Raw data of “poor” results not kept Raw data of “poor” results not kept

1717

Unique Benefits of ELNUnique Benefits of ELN

Integrates heterogeneous data from Integrates heterogeneous data from disparate sourcesdisparate sources

Fully searchable beyond keywords and Fully searchable beyond keywords and indicesindices

Drill-down access to raw dataDrill-down access to raw data Secure access from any computerSecure access from any computer On-the-fly analysis and feedbackOn-the-fly analysis and feedback

1818

New Demand for ELN:New Demand for ELN:21 CFR part 1121 CFR part 11

FDA rule initiated August 1997FDA rule initiated August 1997 Sets standards for electronic submissionSets standards for electronic submission Electronic recordsElectronic records

Thoroughly validatedThoroughly validated Automatic audit trailsAutomatic audit trails Results can be recreatedResults can be recreated

Electronic signaturesElectronic signatures Unique identityUnique identity Linked to e-recordLinked to e-record

No grandfather clauseNo grandfather clause

1919

eRecord DefinedeRecord Defined

““An electronic record is any combination An electronic record is any combination of text, graphics, data, audio, pictorial, of text, graphics, data, audio, pictorial, or other information represented in or other information represented in digital form that is created, modified, digital form that is created, modified, maintained, archived, retrieved, or maintained, archived, retrieved, or distributed by a computer system.”distributed by a computer system.”

--21 CFR part 11.3 (b)(6)--21 CFR part 11.3 (b)(6)

2020

eSignature DefinedeSignature Defined

““An electronic signature is a computer An electronic signature is a computer data compilation of any symbol or series data compilation of any symbol or series of symbols executed, adopted, or of symbols executed, adopted, or authorized by an individual to be the authorized by an individual to be the legally binding equivalent of the legally binding equivalent of the individual’s handwritten signature.”individual’s handwritten signature.”

--21 CFR part 11.3(b)(7)--21 CFR part 11.3(b)(7)

2121

Electronic Authoring, Electronic Authoring, Review, and ApprovalReview, and Approval

Null or current

approved version

Author Reviewer Authorizer

New approved version

ES

AUTHORINGPROCESS

REVIEW & APPROVALPROCESS

2222

Those Who BenefitThose Who Benefitfrom ELNfrom ELN

ScientistsScientists Data analysis, not data managementData analysis, not data management

Lab managersLab managers Data management, not notebook managementData management, not notebook management

Compliance officersCompliance officers Complete audit trails with no paper chaseComplete audit trails with no paper chase

QA/QC directorsQA/QC directors Concurrent accessibility of all dataConcurrent accessibility of all data

Corporate attorneysCorporate attorneys Complete, Complete, legallegal records for litigation support records for litigation support

2323

Concerns about ELNConcerns about ELN

Major change impositionMajor change imposition Restructuring of scientists’ core activitiesRestructuring of scientists’ core activities

Loss of privacyLoss of privacy Notebook is transformed from a personal journal to Notebook is transformed from a personal journal to

a community centera community center

Loss of controlLoss of control Data and metadata could be altered by othersData and metadata could be altered by others

Corporate impositionCorporate imposition Roll-out by executive fiat, not individual adoptionRoll-out by executive fiat, not individual adoption

2424

Cost vs. Value forCost vs. Value forLaboratory NotebooksLaboratory Notebooks

0

5

10

15

20

25

30

0 2 4 6 8 10 12

Time

Monet

ary un

its

Cost-PN Value-PN Cost-ELN Value-ELN

2525

ELN Impact StudyELN Impact Study

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

2626

Collaborative ELNCollaborative ELN

scientist

clinician

researchspecialist

nurse

dataencoder

labtechnician

labmanagerstatistician

writer

2727

Stratified Collaboration Stratified Collaboration Using ELNUsing ELN

dataencoder

labtechnician

labmanager

researchspecialist

clinicianscientist

Data

Information

Knowledge

2828

CENSACENSA

Collaborative Electronic Notebook Systems Association

ELN FunctionalityELN Functionality

Examples from KalabieExamples from Kalabie™™ and LABTrack and LABTrack ™™

3030

Experiment EntryExperiment Entry

3131

Experiment ManagementExperiment Management

3232

Experiment ReviewExperiment Review

3333

Making Page EntriesMaking Page Entries

3434

Revising Page EntriesRevising Page Entries

3535

Embedding GraphicsEmbedding Graphics

3636

Notarizing a PageNotarizing a Page

3737

Maintaining an Audit Maintaining an Audit TrailTrail

3838

Searching the NotebookSearching the Notebook

Analytical Support for R&D Programmes through ELN

Walk Up services for Analytical clients

Instrument interfacesfor direct transmissionof data to LIMS

General access from Lotus Notes

ELNELN

LIMSLIMS ReferenceData

ReferenceData

DataAcquisition

DataAcquisition

ReportsDatabaseReports

Database

ELNELNELNELN

ELNELN

Programs& ProjectsPrograms& Projects

SummaryDatabaseSummaryDatabase

LotusNotesLotusNotes

WalkUp

WalkUp

MRPMRP

Mfg Problem Solving databases

Kodak UKKodak UKKodak UKKodak UK

4040

A True Story…A True Story…

4141

The Loss…The Loss…

One month of work by postdocOne month of work by postdoc $3,000 in labor and supplies$3,000 in labor and supplies Protocol to replicate experimentsProtocol to replicate experiments

4242

The Consequences…The Consequences…

In effect, experiments had never been In effect, experiments had never been donedone

No preliminary data for NIH grant No preliminary data for NIH grant applicationapplication

No supporting data for related No supporting data for related publicationpublication

4343

The Moral…The Moral… ELN is needed as much in academia as ELN is needed as much in academia as

it is in industryit is in industry

Questions & Questions & CommentsComments