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Clinical Data Management, 2nd Edition. Richard K. Rondel, Sheila A. Varley, Colin F. Webb
Copyright 1993, 2000 John Wiley & Sons Ltd
ISBNs: 0471-98329-2 (Hardback); 0470-84636-4 (Electronic)

Clinical Data
Management
SECOND EDITION
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Clinical Data
Management
SECOND EDITION
Edited by

RICHARD K. RONDEL
University of Surrey, UK

SHEILA A. VARLEY
Quintiles (UK) Ltd. Berkshire, UK

COLIN F. WEBB
Amgen Ltd, Cambridge, UK

JOHN WILEY & SONS, LTD

Chichester . New York . Weinheim . Brisbane . Singapore . Toronto
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First published 1993 (reprinted 1994; 1995, twice; 1996; 1998, twice), Second Edition
published 2000
Copyright 1993, 2000 by John Wiley & Sons Ltd,
Baffins Lane, Chichester,
West Sussex PO19 1UD, England
National 01243 779777
International (+44) 1243 779777
e-mail (for orders and customer service enquiries):
cs-books@wiley.co.uk
Visit our Home Page on http://www.wiley.co.uk
or http://www.wiley.com
All Rights Reserved. No part of this publication may be reproduced, stored in a retrieval
system, or transmitted, in any form or by any means, electronic, mechanical, photocopying,
recording, scanning or otherwise, except under the terms of the Copyright, Designs and
Patents Act 1988 or under the terms of a licence issued by the Copyright Licensing Agency,
90 Tottenham Court Road, London, UK W1P 9HE, without the permission in writing of the
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Other Wiley Editorial Offices
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Rexdale, Ontario M9W 1L1, Canada
Library of Congress Cataloging-in-Publication Data
Clinical data management / edited by Richard K. Rondel, Sheila A. Varley,
Colin F. Webb. 2nd ed.
p. cm.
Includes bibliographical references and index.
ISBN 0-471-98329-2 (cased)
1. MedicineResearchData processing. I. Rondel, R. K.
II. Varley, S. A.
[DNLM: 1. Information Systems. 2. Automatic Data Processing.
3. Data Collection. 4. Data Display. 5. Quality Control. W
26.55.I4 C641 1999]
R853.D37C55 1999
610'.285dc21
DNLM/DLC
for Library of Congress 9931926
CIP
British Library Cataloguing in Publication Data
A catalogue record for this book is available from the British Library
ISBN 0-471-98329-2
Typeset in 10/12pt Cheltenham Book by Dorwyn Ltd, Rowlands Castle, Hants.
Printed and bound in Great Britain by Biddles Ltd, Guildford and Kings Lynn
This book is printed on acid-free paper responsibly manufactured from sustainable
forestry, in which at least two trees are planted for each one used for paper production.
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Contents

Contributors vii

Foreword xi

Preface xiii

1 Chapter Review 1
Stuart W. Cummings

2 The International Conference on Harmonisation and its Impact 21

Beverley Smith and Linda Heywood

3 Case Report Form Design 47

Moura Avey

4 Data Capture 75
Emma Waterfield

5 Planning and Implementation 89

Chris Thomas

6 Data Validation 109

Pankaj Panni Patel

7 Quality Assurance and Clinical Data Management 123

Heather Campbell and John Sweatman

8 Performance Measures 143

Jon Wood

9 Data Presentation 159

Munish Mehra

10 Coding of DataMedDRA and other Medical Terminologies 177

Elliot G. Brown and Louise Wood

11 Database Design Issues for Central Laboratories 207

Tom Tollenaere
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vi CONTENTS

12 Computer Systems 229

Louise Palma

13 Systems Software Validation IssuesClinical Trials Database

Environment 249
Steve Hutson

14 Re-engineering the Clinical Data Management Process 271

Steve Arlington, Paul Athey, John Carroll and Alistair Shearin

15 Working with Contract Research Organizations 293

Kenneth Buchholz

16 Data Management in Epidemiology and Pharmacoeconomics 307

Michael F. Ryan and Andreas M. Pleil

17 Future Revisited 325

Ruth Lane

Index 347
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Contributors

Steve Arlington
PricewaterhouseCoopers, West London Office, Harman House, 1 George
Street, Uxbridge, London UB1 1QQ, UK

Paul Athey
PricewaterhouseCoopers, West London Office, Harman House, 1 George
Street, Uxbridge, London UB1 1QQ, UK

Moira Avey
2 Loughton Villas, Crowborough, East Sussex TN6 5UD, UK

Elliot G. Brown
EBC Ltd, 7 Woodfall Avenue, High Barnet, Herts EN5 2EZ, UK

Kenneth Buchholz
INC Research, Charlottesville, Virginia, USA

Heather Campbell
Covance Clinical & Periapproval Services Ltd, 7 Roxborough Way,
Maidenhead, Berkshire S16 3UD, UK

John Carroll
PricewaterhouseCoopers, West London Office, Harman House, 1 George
Street, Uxbridge, London UB1 1QQ, UK

Stuart W. Cummings
Merck Sharp & Dohme (Europe), Inc., Clos du Lynx 5, Lynx Binnenhof,
Brussel 1200, Bruxelles, Belgium

Linda Heywood
Amgen Ltd, 240 Cambridge Science Park, Milton Road, Cambridge CB4 0WD,
UK

Steve Hutson
Barnett International, Parexel, River Court, 50 Oxford Road, Denham,
Middlesex, UB9 49L, UK
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viii CONTRIBUTORS

Ruth Lane
MDS Therapeutic Director, Glaxo Wellcome UK, Greenford Road, Greenford,
Middlesex UB6 0HE, UK

Munish Mehra
M2 Worldwide, 1401 Rockville Pike, Suite 300, Rockville, Maryland 20852,
USA

Louise Palma
Berlex Laboratories Inc., 340 Changebridge Road, PO Box 1000, Montville,
New Jersey 07045-1000, USA

Pankaj Panni Patel

Manager, Contract Operations and Resource Management, SmithKline
Beecham Pharmaceuticals, New Frontiers Science Park (South), Third
Avenue, Harlow, Essex CM19 5AW, UK

Andreas M. Pleil
Pharmacia & Upjohn AB, Lindhagensgatan 133, S-112 87 Stockholm, Sweden

Richard K. Rondel
HPRU Medical Research Centre, University of Surrey, Egerton Road,
Guildford, Surrey GU2 5XP, UK

Michael F. Ryan
460 Foothill Road, Bridgewater, New Jersey 08807, USA

Alistair Shearin
PricewaterhouseCoopers, West London Office, Harman House, 1 George
Street, Uxbridge, London, UB1 1QQ, UK

Beverley Smith
Amgen, Inc., One Amgen Center Drive, Thousand Oaks, California
91320-1789, USA

John Sweatman
7 Fox Covert, Lightwater, Surrey GU18 5TU, UK

Chris Thomas
Covance Clinical & Periapproval Services Ltd, 7 Roxborough Way,
Maidenhead, Berkshire S16 3UD, UK
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CONTRIBUTORS ix
Tom Tollenaere
T2 Data Consult BVBA, Willemstraat 28, B-3000 Leuven, Belgium

Sheila A. Varley
Customer Strategic Business Unit, Drug Development Services, Clinical
Services Europe, Quintiles Ltd, Ringside, 79 High Street, Bracknell, Berkshire
RG12 1DZ, UK

Emma Waterfield
Clinical Trials Research Ltd, 107/123 King Street, Maidenhead, Berkshire
SL6 1DP, UK

Colin F. Webb
Amgen Ltd, 240 Cambridge Science Park, Milton Road, Cambridge CB4 4WD,
UK

Jon Wood
Phoenix International UK, Mildmay House, St Edwards Court, London Road,
Romford, Essex RM7 9QD, UK

Louise Wood
Epidemiology Unit, Post Licensing Division, Medicines Control Agency,
Market Towers, 1 Nine Elms Lane, London SW8 5NQ, UK
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Foreword

Clinical data management is a profession with increasing importance

within pharmaceutical research and development. The diverse lineage of
clinical data management coupled with a wide range of responsibilities
makes a clear, clean definition of clinical data management difficult at
best. As complex and diverse as the profession is, it is a field in which the
number of substantial publications is extremely small. The first edition of
this book provided one of the very few in-depth resources for clinical data
management professionals. This second edition continues in that tradition
by expanding and updating that knowledgebase.
Authored by professionals on both sides of the Atlantic, this text is
reflective of the current trends of global harmonisation of clinical research
and development. With the global consolidation of the industry, it is crit-
ical to understand, appreciate and be able to work within the framework of
global clinical development. This text should contribute to that
understanding.
As the global clinical data management discipline continues to grow we
can rightfully expect an increase in the amount of research and reference
material, such as this book, available to those working in and around the
pharmaceutical industry. This is good for all involvedauthors, pub-
lishers and readers!

Paul R. Loughlin
Chairperson,
Association for Clinical Data Management (ACDM)
Dr Kenneth Buchholz
Chairman of the Board of Trustees
Society for Clinical Data Management
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Preface

Clinical Data Management has come a long way in the last decade. It is now
a firmly established discipline in its own right, and is becoming an area
that people know about and can progress their careers within.
We feel that the next decade will see major changes with the advantage
of electronic data capture. The clinical and data jobs/disciplines as we
know them today will become one as companies use more and more
sophisticated hardware and software to streamline and eliminate duplica-
tion from the clinical trial process. Gone will be the days of the Investiga-
tor giving the CRF to CRA, CRA giving the CRF to DM, DM giving the CRF to
DE. DE enters it, gives CRF back to DM and so on.
The ever increasing computerisation of the worldwide healthcare sys-
tem will mean a practically paperless environment when study protocols
will specify what data points at which intervals need to be transmitted
from the clinic to the company headquarters via electronic means.
The need will then be for strict computer validation to audit trail data
edits, electronic querying of data and mechanisms to ensure the host
database at the hospital site is updated correctly and not corrupted.
The industry is still contracting, with more and more mergers and aqui-
sitions occurring daily. The world of Contract Research Organisations has
started to follow, with CROs, often of considerable size, going through
takeovers and mergers to supply the type and size of service that the new
emerging pharmaceutical companies need. We are seeing the emergence
of virtual pharmaceutical/biotechnology companies who have no inten-
tion of having their own clinical research staff, but who just buy in a drug
and then rely on the service industry to take it to the market place.
We predict that the top pharma/CRO companies today will not be the
players of tomorrow unless they now address the necessary structures
and technology to move themselves into the New Tomorrow, and the true
advent of electronic data capture.

RKR
SAV
CFW
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Clinical Data Management, 2nd Edition. Richard K. Rondel, Sheila A. Varley, Colin F. Webb
Copyright 1993, 2000 John Wiley & Sons Ltd
ISBNs: 0471-98329-2 (Hardback); 0470-84636-4 (Electronic)

Index

Abbreviated NDA (ANDA) 161 Case-control studies 314

ADROIT 187 Central laboratories, database
Adverse drug events (ADEs) 100, 165, design 20728
169, 308, 310, 314, 317 CIOMS process 18, 311
by treatment group 175 Clean databases 2267
Adverse drug reactions (ADRs) 178, CLINflo Version 2 2424
180, 187 Clinical data, types 1646
reporting program 310 Clinical Data Management (CDM) 15,
terminology 181 2642, 75, 76, 79, 81, 82, 87
Adverse Event Reporting System data validation 11119
(AERS) database 200 future 1819, 32645
Aggregate data 167 primary objective
to identify outliers 171 quality assurance 11920, 12341
AlmediFAX 244 future 13940
Alphanumeric codes for missing requirement in GCP 109
values 221 training 1356
Assessment 105 see also Data management
Audit trails 2227 Clinical research, issues for the
comparison of designs 2256 90s 2734
design approaches 2235 Clinical study reports, content and
Audits 8, 12535, 138, 140 structure 323
certificates 135 Clinical Trial Management System
clinical study (CTMS) 1489
computerised system 2545 Clinical trials
data 1313 computer systems in 3940
data management 130 design 336
definition 125 general considerations 289
documentation 1301 statistical considerations 336
figures 1334 Clintrial Version 4 database
investigator site 12730 system 234
key variables 132 Coding of data 1011, 132, 133, 146,
listings 1334 177205
process 138 need for 1789
QA 132, 133 problems 17981
tables 1334 Coding System for a Thesaurus of
Adverse Reaction Terms. See
Billing records 3201 COSTART
Biologic Licence Application (BLA), Cohort studies 316
electronic format 41 Communication
British Association for Research extension 328, 3402
Quality Assurance (BARQA) 127 re-engineering 290
Compliance Program Guidance Manuals
Case Report Form. See CRF 123
Case Report Tabulations (CRTs), Computer Assisted New Drug
electronic submission 42 Application (CANDA) 156, 331
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348
Computer Assisted Product Licence
Application (CAPLA) 331, 332
Computer systems 1213, 22947
analysis and testing 2323
applicable guidelines and
regulations 208
audit 2545
benefits of new processes and
technologies 22930
definition 252
development of clinical
systems 234
establishing evaluation
criteria 2302
evaluation of commercial
systems 23445
in clinical trials 3940
overall objectives 2301
prospective validation 260
retrospective validation
25760
technical criteria 2312
testing 2612
validation 250, 254, 261
verification 2601
Computer validation 139
Construct validity 318
Content validity 318
Contract Research Organisations
(CROs) 1617, 75, 91, 101, 113,
273, 293305, 342
access to additional sites/
patients 295
contract details 299301
contract group 300
delivery dates 299300
disaster recovery 2989
expectations 299
new approaches in working
relationships 3034
price considerations 301
procedures 2978
quality considerations 2956
quality standards 300
reasons for working with 2945
Request for Proposal (RFP) 296
role as supplemental staff 2945
selection considerations 2959
sponsor relationship with 3013
staff resources 296
systems validation and
compliance 297
INDEX
therapeutic, regulatory or functional
expertise 295
up-front investment of time and
resources 3001
work environment 297
Cost-benefit analyses 310
Cost-effectiveness analyses (CEA) 309
Cost-minimisation analyses 309
Cost-of-illness studies 309
Cost-of-treatment studies 309
Cost-utility analyses 310
COSTART 132, 180, 1823, 188, 202
Council of International Organisations
of Medical Science (CIOMS) 18,
311
CRF 6, 7, 4773, 76, 77, 79, 81, 82, 96,
101, 109, 123, 128, 234
analogue scales 601
data collection 524
Age datum 534
precision 53
data duplication 71
definition 47
design 23, 5168, 118, 320, 321
closed response 5660
combination of open and closed
response 60
content 524
diary cards 623
house style 648
matrices 59
methodology 638
open response 546
presentation 5463
wording 612
electronic format 42, 82, 331, 333
function 478
library 72
life history 48
missing data 118, 212
mock-up 68
production 6870
protocol 4851, 93
review meetings and version
control 51
review 72
standard modules 702
tabulations (CRT) 167
time and event schedule 501
workflow systems 23944
CRF-Documetrix 23941
CRFTrack 2412
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INDEX
Criterion validity 318
Culture evolution 328, 3445
Cycle times 1503
Data audits 1313
Data capture 34, 7587
automated data acquisition from
optical images 802
background 76
choice of method 845
electronic 329
electronic diaries 84
fax-based 7980
future prospects 857
medical records 86
remote, via Internet 856
remote electronic 138
single/double data entry 767
smart cards 87
traditional methods 769
Data Clarification Form (DCF) 241
Data coding. See Coding of data
Data collection 1445
alternatives 234
role of data manager 3202
Data corrections 2227
system requirements 2225
Data duplication 71
Data entry 99, 145
centralised vs local 789
MedDRA 1945
remote (RDE) 4, 824, 2389
screen design 778
Data entry systems 4
Data flow diagram 989
Data handling 21318
unexpected results 21920
Data inconsistencies 21013
Data integrity 31719
Data listings 167, 170
Data management 143, 274
audits 130
details 94
epidemiology 3078
pharmacoeconomics 30810
pre-initiation activities 320
project team 102
strategies 344
technology in 32734
see also Clinical Data Management
(CDM)
Data managers, challenges facing 328
349
Data normalisation 207
Data presentation 910, 15976
analysis 171
categorising schemata 164
clinical research issues 1602
general issues 1624
poorly designed 163
quality assurance 171
raw data 1667, 170
samples 1726
summary data 1679
validation 1701
well-designed 164
Data Protection 338
Data quality 31719
as performance measure 14950
factors affecting 11819
Data retrieval, MedDRA 1958
Data sourcing
epidemiologic studies 31012
pharmacoeconomic studies 31012
Data structures, testing 233
Data transfer, electronic 156
Data validation 67, 10919, 146
CDM 11119
during clinical trial 11019
future 1201
investigator 110
monitor 11011
see also Validation
Databases
avoiding enforced uniqueness
21718
clean 2267
Clintrial version 4 2346
design 1112, 166, 209
central laboratories 20728
unexpected results 21822
DLB Recorder 2367
editing 146
exploiting 3278
ideal 318
new releases 234
normalisation 20913
normalisation and inconsistent
data 21013
normalised vs denormalised 162
primary data and sources 311
QOST 312
validation, case study 2637
Date conventions 119
Decommissioning 256
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350
Definitions for expedited
reporting 312
Demographics by treatment
group 173, 174
Descriptive statistics 169
Descriptive studies 314
Diary cards 623
Dictionary coding 97
Disaster recovery 2989
Discriminant validity 318
DLB Recorder database management
system 2367
Document Management Systems 234
Documentation 95, 132, 256
audits 1301
system development life cycle model
(SDLC) 262
validation 261, 2689
Drug Information Association
(DIA) 127
Drug Safety Monitoring Boards 339
DSM-IV 177
Edit Check Specification (ECS) 113
demography 117
document 113, 117
finalisation process
for in-house studies 114
for studies contracted to
CRSs 115
request for amendment 116
team 113
Edit checks
defining 11318
implementing 114
timelines 118
Efficacy topics, ICH 45
Electronic data transfer 156
Electronic diaries 84
Electronic document management
systems 239
Electronic format
Biologic Licence Application
(BLA) 41
CRFs 42, 331, 333
CRTs 42
Establishment Licence Application
(ELA) 41
NDAs 41
Product Licence Application
(PLA) 41
regulatory submission
INDEX
Electronic laboratory data 119
Electronic mail 100
Electronic packages 139
Electronic records 389
Electronic signatures 389, 139
E-mail addresses 43
Emerging markets 328, 345
Enforcement Policy 39
Epidemiology 1718
data integrity and quality 31719
data management 3078
data sourcing
study validity 31719
Error metrics 135
Establishment Licence Application
(ELA), electronic format 41
European Agency for the Evaluation of
Medicinal Products (EMEA) 160,
200, 338
European Union (EU) directive 367
Experimental designs 31317
Experimental studies 31314
Expert Working Groups (EWGs) 24
Face validity 318
FAX-based systems 330
Feedback 105
Field monitoring guidelines 118
Figures 169
audits 1334
Food and Drug Administration
(FDA) 378, 160, 249, 310, 3312
Future of clinical data
management 1819
Good Automated Laboratory Practice
(GALP) 208, 249
Good Automated Manufacturing
Practice (GAMP) 249
Good Clinical Practice (GCP) 6, 7, 123,
208, 250
CDM requirement
Consolidated Guideline 2931
European 253
Harmonised Tripartite Guideline
for 21
ICH 2534
regulations 252
Good Laboratory Practice (GLP) 208,
250
Good Manufacturing Practice
(GMP) 249, 250
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INDEX 351
Good Manufacturing Practice (GMP) security 3334
regulations Intranets 341
Graphs 169 Investigator site audits 12730
IRIS Clinical 2445
Handover meeting 134 ISO 9000 1378, 208
Harmonised Tripartite Guideline for ISO 90003 208
Good Clinical Practice 21 ISO 9001 137
Health Maintenance Organisations
(HMOs) 273, 310, 340 J-ART 181, 189
Health Management Organisations
(HMOs) 340 Key variables, audit 132
Homeworking 87
HTML 334 Laboratory data 97, 165, 169
Laboratory information systems
ICH 1, 2146, 1778, 311 (LIMs) 217
administrative steps 245 Large simple trials (LST) 317
conferences 223 Listings, audits 1334
efficacy topics 45 LOINC 177
future 24
guidelines 2642 Maintenance and Support Services
history 22 Organisation (MSSO) 198200
multidisciplinary topics 46 Medcaid 311
new rules/guidelines 3642 MedDRA 11, 32, 177, 187204, 336
organisation 23 background and development
quality topics 46 1879
recommendations 43 data entry 1945
safety topics 44 data retrieval 1958
Secretariat 234 haemorrhage special search
Steering Committee 234 category 198
topics and guide lines 446 implementation 2001
Image character recognition (ICR) 4 maintenance framework 199
Implementation organ classes 191
and planning 56, 89107 scope and utility 18990
control 1067 strengths and weaknesses 2014
measures 1056 structure 1904
process Medical Dictionary for Drug Regulatory
review 1045 Activities. See MedDRA
satellite 90 Medical records, direct access 86
Incentives 106 Medical terminologies 181204
Information exchange 101 Medicare 311
Institutional Review Board (IRB) 320 Medications 165
Intelligent character recognition Metrics 1056
(ICR) 81 error 135
Interactive Voice Response (IVR) 161 reporting 146
International Classification of Diseases Microsoft Project 102
(ICD) 1847 Missing data 118, 212
International Classification of Diseases Missing values
(ICD) oncology 177 and codes 2201
International Conference on reporting 222
Harmonisation. See ICH Monitors 12930
Internet 333, 341 Motivation 106
remote data entry via 856 Multicentre clinical trials 119
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352 INDEX

National Institute of Health (NIH) 338 PROC FREQ 171

Negative numbers 221
New Drug Applications (NDAs) 161
electronic format 41
Normalised database design 2267
Observational studies 314, 316
Optical character recognition
(OCR) 4, 81, 99, 244, 330
Optical mark recognition (OMR) 80,
330
Oracle Clinical Version 3 2378
PAREXEL 245
Patient identifiers,
inconsistencies 21417
Patient initials 214
Patient Synopsis 167, 168, 170
Performance
definition 144
improvements 1356
Performance measures 89, 14357
categories 14653
key milestones 1556
setting the baseline 1535
Pharmaceutical Manufacturers
Association 187
Pharmacoeconomics 1718, 31719
data management 30810
data sourcing
study validity 31719
Pharmacoepidemiology 317
Planning 90104
aim
and implementation 56, 89107
see also implementation
checklist for establishing
requirements 937
location 102
process 98100
requirements 923
resource requirements 1024
scope 94
specification 912
staff opportunities 1034
systems 1002
timelines 94, 978
Plots 169
Pre-entry data review 145
Pre-initiation study activities 320
Prescription-Event-Monitoring
(PEM) 310
PROC UNIVARIATE 171
Process
audits 138
enhancement 327
flow chart 1446
review 335
Product development timelines 2723
Product Licence Application (PLA),
electronic format 41
Project
completion 95
overview 93
Prospective studies 316, 319
Protocol 1289
QOST database 312
Quality assurance group 1257, 1356
personnel training 127, 129
Quality assurance/quality control (QA/
QC) 78, 32, 100, 110, 257, 261
audits 132, 133
CDM 11920
clinical data management 12341,
13940
data presentation 171
definition 1245
embedding 327
software development 2623
summary data 169
Quality of Life questionnaires 330
Quality standards, Contract Research
Organisations (CROs) 300
Quality system 1367
Quality topics, ICH 46
Queries 100
Randomisation 96
Randomised controlled trials
(RCT) 319
Raw data, presentation 1667, 170
Re-engineering 1516, 27191
barriers to progress 2812
baselining the current situation
281
communication 290
definition 2756
developing and prioritising required
changes 278
diagnostic stage 27983
establishing opportunities 2823
formal methods 289
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INDEX 353
getting right, first time 2769 SQL (Structured Query
implementation 279, 28890 Language) 163, 164, 244
managing the transition/ Standard operating procedures
implementation 288 (SOPs) 5, 6, 95, 100, 120, 2656
mobilisation 280 Standards for expedited
need for 2714 reporting 312
presenting solutions to steering Statistical analysis/modeling 169
committee 2878 Status reports 96, 1479
prioritising opportunities Summary data
283 quality assurance 169
project failure/success 275 to identify outliers 171
quick wins 283 Supplemental NDA (SNDA) 161
solution development Surveys 314
approach 2857 System development life cycle model
plan 283 (SDLC) 14, 260
procedure 2849 documentation 262
workshops 286 Systemised Nomenclature of Medicine
targets 2768 (SNOMED) 177
team structure 278, 2845, 2889 Systems validation 1314
time improvement 274
Registration process 338 Tables, audits 1334
Regulations, enforcing 327, 3389 Technology in data management
Regulatory authorities 160 32734
inspections 136 Telecommuting 343
Relational database management Term coding 146
systems 162 Testing, computerised systems 2612
Remote data entry (RDE) 4, 824, Total quality management (TQM) 137
2389 Training
Report audits 1345 clinical data management 1356
Reporting, definitions and site personnel 129
standards 312 Treatment Emergent Signs and
Resource graph 103 Symptoms 165
Resource expansion 328, 3424
Retrospective studies 316 US Agency for Health Care Policy and
Research (AHCPR) 311
Safety
data 274, 31012 V model 260, 262
studies 315 Validation 102
topics, ICH 44 built-in system 2512
trials 308 computer systems 250, 254,
SASASSIST statements 163 261
Serious adverse events (SAE) 96, database, case study 2637
100 definitions 2501
definition 32 documentation 261, 2689
Site Management Organisations plan(ning) 2557, 25763
(SMOs) 273, 336 policy 2557
Smart cards 87 see also Data validation
Software development, quality Validation team 2578
assurance 2623 responsibilities 25860
Software validation 24970 Validity of studies 31719
Source data verification (SDV) 6, 111, Verification, computerised
118, 129 systems 2601
SEQ 0234 JOB WIL8280-400-004 PAGE-0354 IMPORT
REVISED 05NOV99 AT 13:45 BY IG DEPTH: 58.01 PICAS WIDTH 40 PICAS

354 INDEX

Vital signs by treatment group 176 World Health Organisation Adverse

Reaction Terminology. See WHO-
WHO-ART 132, 1802, 188, 189, 202 ART
Workflow systems table 246 World Wide Web (WWW) 85

Index compiled by Geoffrey C. Jones