Transcript [Project Name] Post

Electronic
Laboratory
Notebooks
Douglas Perry, Ph.D.
IU School of Informatics
Da Vinci’s Notebook
 Ca. 1500
2
Curie’s Notebook
 Ca. 1900
3
Prof. X’s Notebook
 Ca. 2000
4
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
5
Data vs. Metadata
 Data
 Raw data
 Processed data
 Final results
 Metadata
 Test conditions
 Methods & SOPs
 Personnel
6
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
7
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
8
“Closed” Notebooks Are
Often Needed
Daily
Weekly
Monthly
Yearly
Never
0
10
20
30
40
Percent responding
Source: Collaborative Electronic Notebook Systems Association
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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
10
Data Flow in the Laboratory
Lab Automation
& Robotics
Chromatography
Data Systems
Data
Warehousing
Equipment
Interfacing
Laboratory
Instruments
Data Acquisition
Data
Analysis
Laboratory Information
Management
Systems (LIMS)
Information Processing
Electronic
Laboratory
Notebooks
Data
Mining
Knowledge Management
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Scientific Data
Management Architecture
Data
Warehousing
Electronic
Laboratory
Notebook
Data Mining/
Data Analysis
DBMS
LIMS
Local Laboratory Network
Instrument
Data Manager
PC
SC
Chromatography Data System
GC
LC
GC
Instrument Network
Manual
Data Entry
SP
F
AB
12
ELN Is Complementary to
LIMS
Source: Amphora Research Systems
13
Functional Hierarchy in
Laboratory Informatics
SDMS, ELN
rules
people
CDS, LIMS
rules
context
DAQ, LAB AUTO
14
Paper vs. Electronic
Laboratory 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
15
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
16
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
17
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
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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)
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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)
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Electronic Authoring,
Review, and Approval
Null or
current
approved
version
Author
AUTHORING
PROCESS
Reviewer
Authorizer
ES
New
approved
version
REVIEW & APPROVAL
PROCESS
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Those Who Benefit
from 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
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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
23
Cost vs. Value for
Laboratory Notebooks
Monetary units
Cost-PN
Value-PN
Cost-ELN
Value-ELN
30
25
20
15
10
5
0
0
2
4
6
8
10
12
Time
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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
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Collaborative ELN
research
specialist
nurse
clinician
data
encoder
scientist
lab
technician
writer
statistician
lab
manager
26
Stratified Collaboration
Using ELN
scientist
lab
manager
lab
technician
Knowledge
clinician
Information
research
specialist
Data
data
encoder
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CENSA
Collaborative Electronic Notebook
Systems Association
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ELN Functionality
Examples from Kalabie™ and LABTrack ™
Experiment Entry
30
Experiment Management
31
Experiment Review
32
Making Page Entries
33
Revising Page Entries
34
Embedding Graphics
35
Notarizing a Page
36
Maintaining an Audit Trail
37
Searching the Notebook
38
Programs
& Projects
General access from Lotus
Notes
Lotus
Notes
MRP
ELN
ELN
Mfg Problem Solving
databases
Summary
Database
ELN
ELN
Analytical
Support for
R&D
Programmes
through ELN
Reports
Database
Walk
Up
Walk Up services
for Analytical clients
LIMS
Reference
Data
Data
Acquisition
Instrument interfaces
for direct transmission
of data to LIMS
Kodak UK
A True Story…
40
The Loss…
 One month of work by postdoc
 $3,000 in labor and supplies
 Protocol to replicate experiments
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The Consequences…
 In effect, experiments had never been
done
 No preliminary data for NIH grant
application
 No supporting data for related
publication
42
The Moral…
 ELN is needed as much in academia as
it is in industry
43
Questions &
Comments