Simon Cook
Interpharm /CRC
Boca Raton London New York Washington, D.C.
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Authors Foreword
In the spring of 1989 I was busy with the life of an overworked Clinical
Research Assistant (CRA), when the Director of Clinical Research walked into
my office. She informed me that my project manager had just resigned, and that
I was to take on his study responsibilities. My initial reaction was one of
excitement at such a battlefield promotion. Nevertheless, this was soon
tempered with self-doubt over whether I had the necessary abilities to rise to the
role.
There was no international Good Clinical Practice (GCP) at this point, and
beyond quoting the 21 Code of Federal Regulations (CFR) 312 Guidelines to
bemused Dutch investigators, I had no study management credentials. So flying
by the seat-of-the-pants, I muddled through my first half-dozen studies, until
someone had the foresight to send me on a management training course. In
writing this book I am attempting to provide the desk reference I needed in
1989. This book was thus planned as an easy-to-read guide to the practical skills
and methods required by project managers running clinical studies.
The book takes as its framework seven core themes: goals, budgets, time,
resources, measurement, communication and training. There are also chapters
on the drug Research and Development (R&D) process, Contract and Research
Organizations (CROs), the clinical study team and Quality Assurance (QA)
audits. Lastly, there is a true-life case history demonstrating how easily a project
can go off the rails, and what can be done to recover the situation. It is thus a
resume of how modern management theory can be brought to bear on the
specialist demands of clinical studies.
I have not attempted to list all the various regulatory requirements in the
countries of the world, but summarize the US and European Union (EU) scene.
This book is for those wishing to sharpen their study management skills. They
may already be project managers, or team leaders drawn from clinical
monitoring, data management, study production support, laboratory,
pharmacovigilance, statistics or medical writing. The book will be a regular
resource for constant reference.
It is also hoped that CRAs, QA auditors, and CRO business developers will
have an interest in dipping into this when delayed in airport lounges.
Having spent several extended periods working in the US, I know what it is
like to be the token Brit on the team. There is much in the adage of two
nations divided by a common language. In the interests of maintaining the
Acknowledgments
Abbreviations
ADME
CANDA
CBER
CDER
CFR
CHO
CMS
CPMP
CRA
CRF
CRO
EEC
EMEA
EU
FDA
FTE
GCP
GLP
GMP
IB
ICH
IEC
IND
IRB
ISO
ISF
ITT
IVRS
KRI
LOI
MAA
MRP
NAS
NDA
PDP
PhRMA
PICF
PM
QA
QC
R&D
RFP
RMS
ROI
SAE
SAER
SAP
SOP
TMF
Tufts CSDD
WHO
WMA
Contents