Work/Life Balance Getting it Right - the Association for Clinical Data

Transcription

Summer 2008 • ISSUE 66
DataMatters
NEWS & VIEWS
Updates from SIGs and Committees
ARTICLES
College Week Autumn 2008
Tips for Working as a CDM Contractor
eDC in An Early Phase Setting
ACDM PEOPLE
David Smith
Jane Tucker
Work/Life Balance
Getting it Right
administration
NEWSLETTER DEADLINES AND PUBLICATION DATES
If you would like to submit an article to the Newsletter or include an advertisement,
then the following dates will help you plan:
Issue
Newsletter Committee
Email to the Editor: [email protected]
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Pfizer Global Research and Development
Tel: 01304 645788
Fax: 01304 652218
Email: [email protected]
Susie Housley
GlaxoSmithKline R&D
Tel: 020 8587 5359
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Roche Products Ltd
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 | www.acdm.org.uk | Issue 66
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welcome
CONTENTS
Delivering Goals
NEWS & VIEWS
4-7 Updates from SIGs
and Committees
ARTICLES
28 College Week Autumn 2008
31 Tips for Working as a CDM
Contractor
34 eDC in An Early Phase
Setting
WORK/LIFE BALANCE
Life Matters
8
10
Volunteering: Challenging
and Rewarding
12
GSK Harlow Community Day
14
Singapore and Thailand
16
To Study or Not to Study,
that is the question...
18
Team Building Exercises
19
Experiences of Working
from Home
22
Coca Tea Prevents Altitude
Sickness – the next Clinical
Trial?
26
What Does Work Life
Balance Mean...!?
27
Hot-Desking
ACDM PEOPLE
37 David Smith
38
Jane Tucker
ADMINISTRATION
39 ACDM Diary
40 So summer is upon us... or at least it should be but has
probably been sent elsewhere as it has not appeared
where I live. It is not exactly listening to what Bill Giles
had to say at the conference. Global warming eh? pah!
ACDM Contact Information
The ACDM board and committees have been very active over the past few
months and this looks set to continue for the immediate future. In early
June, the Board of Directors invited all of the committee members and
SIG chairs to a joint meeting to discuss the overall vision and goals of not
just the ACDM but each individual group and how we all would achieve
these. It was a very fruitful and useful meeting and I am sure you will see
the progress being made in the near future. If you would like to know
more about the specifics then please read the Vision & Goals article in
this newsletter.
I would like to congratulate the newsletter committee, who, under
the stewardship of Jon Milton, produced a fantastic effort with the
Spring Newsletter. I trust you all enjoyed the new newsletter format
and production which mirrored our re-branding of the ACDM. The
newsletter committee has set themselves a high standard that I am
sure will be continued.
The ACDM Website Committee, with the help of Kingston-Smith, has
been working hard to get the new website active. We have had some
technical delays with the release of the site for which we apologise, but I
am sure the end product will be worth the wait and a great improvement
for the ACDM and its members.
Around our re-branding of the ACDM, we have revamped the Public
Relations Committee and they are starting to get our marketing machine
rolling so expect to see a lot more publicity about the activities and
events of various SIGs, Committees and the ACDM as a whole. To assist
with this, the ACDM is looking to engage a Communications Officer, who
will assist all of the members with both providing and disseminating
information. If you would be interested in this role then please see the
advertisement in this newsletter. This appointment will be made by
1 January 2009.
I have mentioned just three of our committees above and their
activities, but all of the committees and SIGs have great plans to deliver
their goals mentioned above and I am looking forward to seeing the
results. As always, people and time are the key elements to making all of
this work so if you would like to get involved then please see the back
of the newsletter and make contact with one of the committee chairs or
Board members.
I wish you all a great summer and happy holidays...
David Baker
ACDM Chair
Issue 66 | www.acdm.org.uk | 
news&views
News and views from around the committees, working parties and special interest groups
ACDM Conference 2008
The ACDM 2008 conference was held
on 31st March-1st April and the venue
chosen was Whittlebury Hall Hotel,
Northamptonshire, the same as last
year. There was substantial feedback
from delegates who attended last year’s
conference that the venue was a good
one, both from a facilities and location
standpoint, backed up again by this
year’s conference.
Attendance was slightly up on last year,
this increase was particularly noticeable
in the number of delegates attending the
entire conference rather than additional
day delegates. The number of attendees
on Sunday was well up on last year,
perhaps reflecting the quality of the
hotel accommodation, the networking
opportunities or the lure of the quiz.
All available stands were booked
bringing down conference costs overall.
Thanks should also go to CK Clinical
and Datatech Search and Selection
who sponsored the wallets, pens and
conference packs.
Sunday evening was a popular event
of networking, eating, drinking and an
80’s theme quiz, in line with celebrations
to mark the 21st anniversary of the
ACDM. The low key and friendly
atmosphere gave ample opportunity to
mix and network with old colleagues
and make new contacts.
To start us off on day 1, Bill Giles OBE
provided an insightful talk on his time
at the BBC Weather centre, setting the
scene for the main theme of climate
change, not only in the meteorological
sense, but also for the changing role of
the Data Manager globally.
Since the main focus of the conference
was climate change, there followed
two presentations on EDC and three on
outsourcing, these changes being the
most relevant to the every day working
life of most data managers currently.
The ever popular breakout sessions
concentrated on four areas of changing
data management, Recruitment/Retention
of Staff, Project Management, Medical
Term Coding and Vendor Management.
To celebrate 21 years of the ACDM,
there was an 80’s theme for the Gala
Dinner complete with a band playing
80’s hits. A great favourite with the
revellers was the themed ‘‘games”, large
scale replicas of games from the 80’s like
‘‘Operation”, still popular today. Quite
apt when you consider the medical
nature of our day to day activities.
Day 2 started with a very popular
presentation, an African Pilot, followed
what has come to be considered as the
highlight of the conference, the Debate
– a lively discussion debating whether
we'd all have jobs onshore by 2012 – not
that far away. Happily, it looks like our
jobs are safe for the moment.
Following on from this theme, there
was a presentation on the changing role
of the data manager and 2 presentations
on offshoring. I think we all learned
Feedback on Individual Presentations (Average Score)
Successful
relationships
The perfect EDC
implementation
64.88 65.38
Offshoring global Clinical
Data Management
65.2
73.05
Deconstructive
thinking
CDSIC & SDTM
Standards
66.09
74.8
75
70.74
How climate change has
affected the role of the data manager
74
Global Offshoring
“Pfizer perspective”
Training
“The offshore way”
Offshoring
Challenge
African pilot
Assessment Categories (Interesting/Learning/Thought Provoking/Useful/Well Run)
Scoring out of a possible 100 points
 | www.acdm.org.uk | Issue 66
Location to be changed
– closer to intl airport
New technology demos, data protection
59.46
73.21
Approach to
offshoring
How Conferences Could be Improved
ePRO handling and challenges
Bayer’s experience
with EDC
63.56
a lot from the CDISC/SDTM standards
session, if just how little we knew about
the subject. The talk on deconstructive
thinking encouraged us all to think
about things in a different way. We
ended the conference again thinking of
how EDC is changing the DM role.
Looking at the delegate feedback from
this year's conference, the comments fall
into three main categories, the venue,
the structure of the sessions and the
quality of the presenters.
The venue scored highly in the
feedback, areas of improvement would
be more seating for the sandwich lunch,
more attention to the type of food served
such as more healthy lunch options with
access to soft drinks, better wifi/mobile
access, better proximity to an airport to
increase attendance of non-UK delegates,
more space required for exhibitor stands
and earlier hotel check in preferred.
These comments will be taken on board
for next year’s conference.
For the general comments, almost
all responders stayed for the whole
conference, the majority of responders
had heard of the conference either
through mailings or colleagues. Almost
two thirds of respondents attended
through personal choice, almost all
the remainder by company policy.
The conference scored highly against
expectations, especially against the
category of making new business
contacts and keeping up to date.
Board meeting during the conference
1
Team build exercise/
introduction at the beginning
1
2
4
2
Joint conferences
with PSI or BARQA
1
EDC discussion
2
Discussion on training and
development programs
available for DM's
1
5
2
Focuss on the future challenges
and resolutions for DM
1
2
Increase number of senior
management attendees
Focuss on information
sharing/each company
lesons learned
More and longer
break out sessions
3
Time for off shoring
discussion to be reduced
news&views
Collaborating to Maximise the
Depth and Breadth of our Articles
We had a competition running in the spring conference special
to determine the best conference report. It was a hugely
difficult decision, especially considering that the standard was
so high and even more so considering the short amount of time
that was allocated to the reporters to write the reports after the
conference. However, and as evidenced by the use of her quotes
throughout the spring newsletter, Becky Hogg is the winner and
will receive vouchers in due course. Well done Becky and we
look forward to seeing a similar standard of reporting next year.
And now, the first plea. Do any of our readers – perhaps the
more (and David Baker will like this) “seasoned professionals”
amongst us, have copies of newsletter issues 1 through 23
(i.e. the copies that pre-date the back catalogue on the web)?
If you do, please could you get in contact with me (editor@
acdm.org.uk)? We are attempting to complete our newsletter
archive, and this would be a tremendous help.
I wanted to take this opportunity to highlight the great
partnership we have been developing with the SCDM’s
Publication Committee. You will see an article from Kenneth
Milstead in this edition of the newsletter, which was first
featured in the winter 2007 edition of Data Basics. Conversely,
Pre-conference and conference
organisation scored highly in the very
good/good categories. Exhibitors’ stands
and facilities were overall rated good. The
entertainment, Sunday evening’s quiz, the
Gala Dinner and Band got very high marks
in very good/good categories.
Compared to other ACDM
conferences, it was pleasing to note so
many first-timers, a target group to pull
in early for repeat business!
Break Out Sessions
Vendor
management
66.2
Coding
70
Recruitment
and retention
of staff
66.1
Project
management
45.7
Assessment Categories (Interesting/Learning/Thought Provoking/Useful/Well Run)
Scoring out of a possible 100 points
the spring 2008 edition of Data Basics contains 3 articles from
previous editions of the ACDM Newsletter. We hope to further
promote this article-sharing, and think it is a great way to
collaborate and maximise the depth and breadth of our articles.
Right, and now time for our second plea, and a call for
contributions to the autumn edition of Data Matters. The
theme will be CDISC, CDASH, SDTM, Standards etc. Obviously
we like our “bespoke” newsletters, but would really welcome
any articles based on this standards-orientated theme.
Finally, I hope that you enjoy this edition of Data Matters and our
work/life balance theme. We feel this is extremely important, and
whilst this edition may be light on DM topics per se (and at times
you may think you’re immersed in an edition of Wish You Were
Here...), we need to remember that there is life outside of work
(I must tell myself this when I’m still bashing keys at unearthly
hours – dedication or stupidity?). Hopefully, through your reading,
you’ll learn more about some of our ACDM members and feel a
stronger sense of belonging to the broader ACDM community.
Jon Milton – Editor, Data Matters
Written on behalf of the Newsletter Committee.
A comment about the pitch of some of
the presentations is particularly valid,
we need to keep the themes applicable
to all levels of DM professionals.
There were many comments on the
presenters and topics, suggesting that
if we wanted to talk about offshoring,
we needed to have representatives
from offshore locations to present.
Unfortunately obtaining visas for overseas
speakers proved too complex for this to be
implemented in time, a great shame and
an opportunity missed. There were also
comments that presentations were either
pitched too high or too low, so perhaps
the take home message for this one is
to provide breakouts of short training
sessions as part of future conferences.
Overall on content, the African Pilot
and Offshore Training scored the highest
in delegate feedback – well done to
Roger Small, Richard Young and Bal
Klear. Can we have more presentations
of this quality next year, please! The
breakout sessions proved to be very
popular and as ever the debate scored
highly as being informative, entertaining
and quite tongue-in-cheek.
Highlights that will stay with me
from this year's conference are the high
level of quality presentations by the
speakers, session chairs who were clearly
enjoying the conference, the debate (I’ll
never think of Margate in the same way
again!!), the inside track on how the BBC
weather forecasts were put together and
finally the delegates with their wonderful
fancy dress at the Gala Dinner.
Special thanks should go to Janet
Ridley and Tina Clayton, without whose
help and support, the conference simply
wouldn’t have happened. I’m already
looking forward to the 2009 conference
and I hope to see you all there.
Vicky Wiggins
Lead Data Manager
PRA International on behalf of the
Conference Committee
Issue 66 | www.acdm.org.uk | 
news&views
ACDM Visions and Goals
As with any individual, group, company or organisation, having a vision and a set of goals to achieve
their vision, are significant steps towards success, growth and satisfaction. The ACDM is no different.
In about 2002 the Board of Directors of the ACDM created
some Visions and Goals for the organisation to aim to achieve
over the following few months and years. These were largely
achieved and we saw a variety of initiatives initiated and
finished.
Over the past few months the current Board of Directors
have been working with the various Committees, Special
Interest Groups (SIGs) and the individual members of the
ACDM to develop a new set of Visions and Goals for the
organisation. A lot of you will have participated in a survey
at the end of 2007 and a lot of the results of this survey have
gone towards setting the goals for the Board of Directors, the
Committees, the SIGs and the organisation to achieve over the
coming three years from 2008 to 2010.
The Board of Directors, after much debate, and taking
into account the changing nature of the data management
discipline within the pharmaceutical industry, has revised and
simplified the Vision of the ACDM to:
“To be the leading organisation supporting professionals
involved in the management of clinical data.”
Our vision will be:
“Achieved through development, education, discussion and
promotion of innovation and best practices, leading to
enhancement of our members’ knowledge and skills.”
There are six main overall goals defined for the ACDM over
the next three years and each of these has had a number of
actions identified that need to be completed to achieve the
overall goal. Each action has been assigned an owner and a
target completion date.
The six main goals, in no order of importance, are:
1. Enhance and promote the benefits of the ACDM to an
increasing global membership.
2. Create an easily accessible and visible information
repository.
3. Establish an active communication platform for the
dissemination of new industry developments.
4. Develop and execute a professional development and
training strategy that meets the challenges of the
membership.
5. Forge and strengthen links with related industry
organisations.
6. Effectively manage the organisation finances to achieve the
organisation’s aims.
The Board of Directors, Committee members and SIG chairs
recently met to discuss these goals and each committee
presented and discussed what actions they were planning
to contribute towards their achievement. Most, if not all, of
these goals, are inter-linked and some actions identified by the
various committees will have benefits to more than one goal.
If you would like to read more about the Visions and Goals,
the actions, who is responsible and the target completion
dates, then please visit the new website where you will find
them in the “ABOUT US” section or alternatively contact the
ACDM office and they will send the document to you.
So far in this article I have spoken solely of the Board of
Directors, Committees and SIGs of the ACDM and their actions
to achieve these goals, however, like with any project, the
more resource available, the lighter the load and hopefully the
quicker things will get done and you, as members, will benefit.
I would like to encourage you all to read the Vision
and Goals document and if you feel you would be able to
contribute towards their achievement then please contact the
ACDM office, a Committee Chair or Board member.
David Baker
ACDM Chair
Mapping thefuture
ACDM Annual Conference
8-10 March 2009
Whittlebury Hall Hotel, Northamptonshire
 | www.acdm.org.uk | Issue 66
news&views
Driving the INCDMA Forward
I recently met Eva HammarstromWickens and, ever the one to pounce
on an opportunity, I managed to
convince Eva that we should provide
some information (for the newsletter)
about the INCDMA, which, for those
of you who are not aware, is the
International Network of Clinical Data
Management Associations. Eva is
our principal representative from the
ACDM, and is ably assisted by David
Quarm and Gail Kniveton.
The goals and objectives of the
INCDMA were revamped recently and I’d
like to extend a huge thank you to Linda
Talley (current Chair of the INCDMA) for
providing these at such short notice. You
will find the fruit of Linda’s work here,
and in addition there is a spectacular
centre-page spread in this edition that
will help to orient you to the make-up of
the INCDMA.
Eva, David, Linda et al, are also
looking for help to drive this initiative
forward and would really appreciate
contact from anyone who may be
interested. If you are (interested), please
get in touch with Eva in the first instance
(Eva’s details can be found on the back
of the newsletter).
Eva reliably informs me that they
will be scheduling monthly one-hour
teleconferences to discuss specific key
topics and keep track of progress. In
addition, the INCDMA will continue
to conduct quarterly two-hour
teleconferences to discuss all topics in
general. I hope this helps to whet your
appetite and spark your interest in a
world outside of the immediate confines
of the United Kingdom.
Jon Milton – Editor, Data Matters
INCDMA goals:
The following main categories summarise
the goals of INCDMA. Some of the goals
listed include several objectives:
Goal:
• Further INCDMA knowledge of, and
influence in, key relevant topics affecting
the discipline of Data Management.
This includes, but is not limited to EDC,
eClinical, eRisk and ePro topics.
Objectives to achieve this goal:
• Liaise with relevant forums,
researching and reviewing relevant
upcoming guidelines for EDC,
eClinical, eRisk and ePro.
• Collaborate with different
organisations to produce training
webinars or tutorials or courses
offered to all the countries
participating in INCDMA.
• Compile a list of documents for
review. Distribute documents to
experts for peer review. Provide global
“To further the globalisation of Clinical Data Management”
Promotion of collaboration among Clinical Data Management groups around the world
International forum for discussion of and feedback on current topics of relevance to the discipline of CDM
Contact:
Email:
Fredrik HANSSON
[email protected]
Finland
FIADM
Finnish Data Management Association
Contact:
Email:
Tiina HARTIKAINEN
[email protected]
Denmark
Germany
DADM
Danish Association of Data Managers
DVMD
German Association for
Medical Documentalists
Contact: Mette RAVN
Email:
[email protected]
Website: www.dadm.dk
Contact: Margarete RUDLOFF
Email:
[email protected]
Website: www.dvmd.de
The Netherlands
France
PSDM
Pharmaceutische Statistiek
en Data Management
DMB
Data Management Biomedical
Contact: Joris CAUQUIL
Email:
[email protected]
Website: www.dmb-asso.org
Contact: Gerald RUITER
Email:
[email protected]
Website: www.psdm.nl
United Kingdom
Switzerland
ACDM
Association for Clinical
Data Management
Contact:
Email:
Contact:
Email:
Eva HAMMARSTROM-WICKENS
[email protected]
Contact:
Email:
David QUARM
[email protected]
Contact:
Email:
Gail KNIVETON
[email protected]
Stephane ROUAULT
[email protected]
Italy
Contact:
Email:
Website: www.acdm.org.uk
Cinzia PICCINI
[email protected]
North America
SCDM
Society for Clinical Data Management
Contact: Linda TALLEY
Email:
[email protected]
Website: www. scdm.org
AHR-DMA – Australasian Health and
Research Data Managers Association
Japan
Contact:
Email:
Israel
Contact:
Email:
Australia
Natanya SLOMOWITZ
[email protected]
Masayuki MAEDA
[email protected]
Contact: Allison BROWN
Email:
[email protected]
Website: www.ahrdma.com.au
ARCS – Association of Regulatory and Clinical Scientists
to the Australian Pharmaceutical Industry Ltd
Contact: Andrew TAYLOR
Email:
[email protected]
Website: www.arcs.org.au
Spain
Contact:
Email:
Almudena COLINO
[email protected]
Goal:
• Provide additional avenues for access
to key information and contacts
globally for INCDMA members.
Objectives to achieve this goal:
• Develop links and collaborations
for access to documentation and
information to be available amongst
its members, which will include both
procedural (constitutions, bylaws,
policies, etc.) and operational
(training materials, laboratory data
guides, GCDMP, coding references,
etc.) documentation.
Goal:
• Proactively engage in the discussion
and analysis of the future direction
of the DM role. Define and identify
additional and changing skill sets,
requirements and training needs.
Themes covered by INCDMA:
• Medical Coding
• Quality Control
• EDC, eClinical, ePro, eRisk
• Data Standards, CDISC
• Laboratory Data
• Good Clinical Data Management
Practices
• Training.
International Network of Clinical Data Management Associations
Sweden
input to relevant draft regulatory
documents and identify documents
for further review.
• Collaborate with DIA CDM and
eClinical SIACs’ representatives to
co-ordinate reciprocal arrangements
for promotion at conferences and
involvement of INCDMA in program
committees for DIA CDM and eClinical
related workshops.
See centrepage spread
of this edition
to orient
you with the
make-up of
the INCDMA.
Linda Talley
Chair of INCDMA
Issue 66 | www.acdm.org.uk | 
WORK/LIFE BALANCE SPECIAL
Life Matters
At a recent Newsletter Committee Meeting we
were further challenging the status quo and actively
brainstorming ideas for future editions of Data
Matters. We are acutely aware that the personal touch
is highly regarded and valued by our readers
Indeed, it offers a touch of light relief
in amidst our business; remember the
“ACDM Birdwoman of Bognor” piece in
the autumn 2007 edition of the newsletter? That was well received.
As such, and with many thanks to Susie
Housley for a moment of inspiration, it
gives me great pleasure to introduce
a new regular feature, “Life Matters”.
Given the theme (work/life balance) of
this summer edition of the newsletter,
we cannot think of a more appropriate
time to unleash this on the ACDM community. We hope it is here to stay; but it
can only stay with your input. We need
you now more than ever! But what do
we want from you, and what will you
get in return?
We would like you to send in any photos you have that portray work/life balance. If you can accompany them with a
clean, newspaper-style pun-tastic headline, that would be even better. We will
endeavour to publish one or two photos
in each newsletter, and then on a yearly
basis will select the best photo (from the
previous year) and award a prize. So, to
start the ball rolling, here are a couple of photos from a recent volunteering experience that myself and a few
colleagues undertook. We hope that
these inspire you. To this end, if you feel
inspired, then please e-mail your photos
and headlines to [email protected].
Photos will be published at the editor’s
discretion. Enjoy.
And now over to Gill
We would also like to hear about your
team building/motivational ideas. Once
again, the success of this as a “regular”
feature is down to you – we can only
include such articles when we receive
them – so every time you have a team
building/motivational event please think
immediately “ACDM Newsletter” and let
us know what you did! We may even
have a prize for this one too – if I can persuade the Editor...
Meanwhile, to get you thinking, here
are a couple of “regular” activities we
undertake every year at Kendle. Apolo-
 | www.acdm.org.uk | Issue 66
gies that I have no photos – but I will try
to get some for future editions!
“...interesting demographics
within the data farming SIG...”
Hop into Spring...
We celebrate Eastertime every year in
our CDM department with the time honoured tradition of holding an annual
Easter Egg hunt. We figure that the exercise of first finding your egg fully works
off any additional calories provided by
then eating your egg! In order that eggs
are dispensed fairly, each egg (and we
use the small, often cream type varieties!) is labelled with an individual name
– you have to find your own egg – and of
course that adds to the fun as inevitably
you find everyone else’s except your own
for quite some time.
I have a wonderful Administrator – she
labels the eggs for us, hides them, and
then laughs for quite some time as we
desperately hunt to find our egg! It’s a
short activity at minimal cost, important
of course especially for a CRO, but lightens the day and provides some fun and
laughter.
Munch into Summer...
Our annual BBQ has become a regular
CDM summer event. We do not have
extensive grounds, but we have a small
area of car park at the back of our building which, on one day each year we ban
cars from and instead cook up a (we
hope) delicious BBQ. We buy disposable
BBQs and volunteers from CDM (usually
male – what is it with men and BBQs?!)
do the cooking whilst the managers prepare the food and serve it all. After the
BBQ and salad we finish off with strawberries and cream – a nice Wimbledon touch! We usually manage to have
music playing as well and often have a
free raffle too. Thankfully we seem to
(touch wood and dare I say it...) pick
good weather each year.
Autumn and Winter wonderland...
Here I’m waiting for sparks of inspiration from someone else – so please let
us have your ideas and news of how you
have fun at work!
“...much to the PM’s dismay, the
DM decided once again to shift
the goalposts...”
Thanks Gill. And now, back to me –
please remember, this feature is yours.
We do not want you to feel restricted
to the suggestions we have laid out
here. Please just let us know what
matters to you and we’ll publish it...
[email protected]
Jon Milton and Gill Lawrence
Written on behalf of the Newsletter
Committee.
Issue 66 | www.acdm.org.uk | 
Volunteering: Challenging and Rewarding
On starting to write this article, I thought I would consider the meaning of the verb “to
volunteer”. There is a danger that you can unwillingly be volunteered to do a task, especially if
you are not present at the time to decide otherwise. “To volunteer” is defined as “to perform or
offer to perform a service of one’s own free will” or “to do charitable or helpful work without
pay.” (www.thefreedictionary.com)
Volunteering has played a major part in
my life since the beginning of 2002. How
I came to volunteer for Samaritans took a
long and possibly strange route.
When I married Ken in 1981, we moved
from Newbury, Berkshire, to Ashford, Kent.
During the 1980s, we had two friends
who committed suicide – one with a shotgun and one following an overdose. Over
the years, we have also lost friends and
family, mostly to cancer. We were lucky
enough to be able to offer each other
support, although some people are not in
that same position and turn to contacting
the Samaritans when suffering emotional
distress due to bereavement.
In 1988, my full time working changed
to being a full time Mum, when I had my
son, George. Around this time, my Husband became both a Parish and Borough
Councillor. As the Councillor’s Wife, I
became more involved in local issues and
organisations. It was almost expected
that I joined the Singleton Women’s Institute, where I served a couple of terms as
President. This WI Branch was small, but
everyone was very friendly and it felt like
an extended family.
In 1999, due to various personal circumstances, we decided to move back to
Newbury. This was realised from September 2000 when I was employed by MDS
Pharma Services, Winnersh Triangle,
approx. 23 miles away from Newbury.
Once settled in my new job and relocated,
I joined a suitable local WI group. However, after attending for some months, it
just didn’t feel the same as my previous
group at Singleton WI, so I left.
At the beginning of 2002, an advert in
the local newspaper caught my eye. The
Newbury Samaritans Branch was looking
for more volunteers, so I contacted them
 | www.acdm.org.uk | Issue 66
and was immediately invited for an interview. Selection followed a short while
later. A friend from Singleton WI provided
a character reference and shortly after I
was informed that I had been accepted
to start the preparation training. A couple of months later, I was provided with
a “minder” (an experienced volunteer)
with whom I shared duties, first listening
in on her calls and soon taking my own
calls, with my minder listening in. Once I
had completed an overnight duty, I was
allowed to organise my own duties, committing to a weekly duty and one overnight duty every four weeks, totalling
around nineteen hours per month.
For me, volunteering is both
challenging and rewarding.
It has made me realise
that there are so many
people in the world who
are emotionally distressed,
even suicidal, and many
more who are just lonely
and in need of somebody
to talk to and who will take
time to listen to them.
Volunteers need to be prepared to
receive calls from those who are suicidal, depressed, bereaved (which could
be loss of a relative, friend, pet or job),
lonely, in prison, sexually or physically
abused, transsexual, homosexual, the list
is endless, as well as meeting callers face
to face at the branch or answering emails
from callers around the world. Callers
could also be concerned for a relative or
friend. A proportion of callers are hoax
or timewasters – unfortunately, some
people abuse the system as it is cheaper
than phoning a dedicated sex line. Again,
training enables the volunteer to recognise, filter and deal with such calls in an
appropriate manner.
There are times when volunteers may
find themselves talking to somebody in
the middle of a suicide attempt. As hard
as it may seem at the time, it is not the
Samaritan’s responsibility to talk somebody out of committing suicide – the volunteer can only offer to stay with that
person in order to offer support and a
listening ear. However, the volunteer is
trained to try and extract an address and
phone number in such cases, as well as
information on what pills may have been
taken or other factors involved, and be
ready to call an ambulance, if the caller
agrees to this or is unable to make the
decision themselves. The volunteer will
offer to stay on the line until the very
end or, if the caller has agreed, until paramedics arrive on the scene. As you can
imagine, it can be very distressing for
the volunteer to witness a suicide, but
the choice of death by suicide can only
be made by the person wishing to commit suicide and that choice is respected
by the Samaritan volunteer. It is also
unlikely that the volunteer witnessing a
suicide attempt will receive feedback on
whether that person survived and perhaps tried again.
The responsibility of the Samaritan is
not to counsel or advise – their role is to
listen and to be empathetic. The aim is to
provide support to those in need and in
a non-judgemental way. Callers are reassured that the service is confidential – if
a volunteer were to report confidential
acdm_iss63
15/10/07
10:02 am
Page 8
ARTICLE
information to another authority, such as
the Police, the volunteer would be unable to continue as a Samaritan.
In addition to caller care, volunteer
care is paramount. Support for volunteers
experiencing “difficult” or emotional calls
can be received from the co-volunteer on
duty with you, as well as your duty leader.
It is the responsibility of each volunteer
to “offload” after every duty so that they
do not leave the centre worried or upset
after an emotional duty. Each volunteer
is also assigned to a support group – the
group meets regularly to discuss branch
and regional activities, training and individual support. I am further committed
by being one of the Duty Leaders on rota,
which means that I am contacted by volunteers at the end of their duty as part of
the emotional off loading process as well
as being responsible for the smooth running of the centre during my weekly duty
leader evening and overnight.
Training received to be a Samaritan, as
well as experience gained, has helped
in every day life too. I have always considered myself to be a good listener. To
be a Samaritan, you need to be able to
listen, be non judgemental and not feel
awkward during silences – when a caller
can be finding it difficult to talk and just
needs to know that somebody is on the
other end of the phone when they are
ready. This listening “skill” also proves
invaluable when being interviewed by an
MHRA Inspector or an auditor! Some people find it difficult to remain silent during
such an interview and try to “fill” silences
– dangerous as it is during this time that
information is unwittingly offered over
and above just answering the question.
My role as a Samaritan volunteer does
not stop at just taking calls from those
with suicidal feelings or in need of emotional support. I am also involved with
the Southern Regional Training Team,
which provides personal development
courses to assist in such things as being
a leader, being motivated or being able
to provide training to those within your
branch – all of which can help individuals in work or family situations as well as
The ACDM Bir
dwoman of Bog
nor
Friday (31st August)
started out like
any other normal
company emails.
working day
I noticed a contact
for me. I checked
from my friend
apathy, so I opened
my personal email
Marion, who
the email...
lives in Dorset,
account as well
entitled “Bognor
as my
Birdman”. Curiosity
...This was in fact
overcame
a request for a
friend to
join her in an
Now, family, friends
activity which
and acquainta
was to take
place that very
nces
will know and vouch
least thought that
weekend . The
for me that I rarely
he did after knowing
email
included phrases
do
things on impulse.
me
for 31 years and
like, “Am looking
It is much easier
being married for
for
someone to jump
to say
26 years)
“No”, so I don’t
and
knew
off a pier with
I do not normally
really know why
me... I
need someone
do things on
I said
“Yes” on this occasion.
impulse, especially
to dress up as
Perhaps it was
a fairy or an
something as mad
angel, complete
one
of
the
and
physical
items
with a wand,
on my list of “Things
as jumping off
we then
a pier. It was totalhave to pirouette
to do
before reaching
ly out of character
to the edge of
the age of 50”.
for me to suggest
the pier
while they play
I spoke to Marion
doing
such a thing. He
dance of the sugar
the next day to
was obviously concerned
plum
fairies over the
make
the arrangements
for my safety (with
tannoy, then jump
– as nobody else
questions like
off. Simple really.”
had
offered (surprise,
“Where
are the insurance
surprise!). There
documents?” and
was litI thought about
tle time to sort
“Do
you realise how
it (probably not
out a fancy dress
cold the sea is?”
long
costume,
enough!) and sent
but accessorie
and, on
arriving at Bognor
her an email saying
s would save time.
on the Sunday
that
if nobody else offers,
Then I
morning,
mentioned it to
“Where is the
I would do it with
my husband Ken.
car key?” to which
her
– a friend in need
To say
I replied
that he was shocked
“I am taking it
and all that!
is probably an
with me” – this
underbeing my
statement – he
assurance to be
knows me too
rescued if he wanted
well (or at
to be
able to drive home
again), but I reassured
him that it is a
safe event – evidently,
since
its start in 1971
at Selsey before
moving to
Bognor from 1978,
there have been
no
serious injuries.
However, my
husband is
responsible for
health and safety
at work,
together with
risk assessmen
ts, and it
should be remember
ed that there is
always
a first time for
everything.
Ken agreed to
come along with
me and
take photos so
that there was
evidence of
the event.
We arrived in Bognor
on Sunday morning,
parking outside
the Bognor Samaritan
Centre – ironic,
s
as this was in fact
the charity for which we
were jumping. It
was strange
to think that we
were supporting
a charity
PA G E 8
63
Jean Cornhill jumping off
Bognor Pier to raise funds
dealing with callers.
Some of you may remember reading the article in a previous ACDM Issue
No. 63 Autumn 2007 called “ACDM Birdwoman of Bognor”, when I jumped off
Bognor Pier to raise funds. There was to
have been a repeat performance during
this year’s event scheduled at the beginning of July, but this was cancelled due
to the length of the pier being reduced
and safety being threatened due to the
reduced water depth at the end of the
pier. The pier jump was one of my more
unusual fundraising stunts, although
another which happened some years
earlier comes close when I sat in a local
departmental store window with my
wrists chained and padlocked as part of
“I’m a Volunteer... Get me out of here”.
Locals were invited to donate money to
select a key which opened one of the
padlocks to release a volunteer.
Being a volunteer in any organisation
or charity will make a difference to others as well as yourself. You can spend as
little or as much time as you can spare.
For me, volunteering is both challenging and rewarding. It has made me realise
that there are so many people in the world
who are emotionally distressed, even suicidal, and many more who are just lonely
and in need of somebody to talk to and
who will take time to listen to them.
In being a Samaritan, I have also gained
so many new friends on a local, regional
and national level. I have attended a
number of the Annual Conferences held
in York and had the privilege to personally
meet the Founder Rev. Chad Varah, who
died last November at the age of 95, as
well as singers Tom Robinson and Lee Griffiths – who performed for the delegates.
My Company, MDS Pharma Services,
recognises and rewards employees who
volunteer, as part of the Employee Volunteer Program. Once an employee has
completed at least 79 hours of volunteering in any financial year, they are entitled
to apply for a payment equivalent to 250
Canadian Dollars to be presented to their
chosen charity.
If you want more out of your own life, as
well as being able to help others, choose
to volunteer. Samaritans are always in
need of volunteers – to make a regular
commitment to answer the phones or
even to assist with administration tasks or
valuable fundraising – which could even
involve jumping off a Pier... like me!
Jean Cornhill,
Clinical QA Auditor,
MDS Pharma Services
Samaritans can be contacted as
follows:
Tel: UK 08457 909090
Letter: PO Box 90 90, Stirling FK8 2SA
Visit: local branch
For other countries, contact:
Befrienders International:
www.befrienders.org
Issue 66 | www.acdm.org.uk | 
GSK Harlow Community Day
On May 22nd, National Biodiversity Day, Harlow CDM
(including all phases, technical & dictionary groups) joined
forces to make a difference in our local SSSI (site of special
scientific interest), Parndon Wood.
We had agreed with the Harlow District
Council’s Biodiversity officer, Glenn Mulleady, that we would tackle some jobs that
required more brawn than brains given
that our knowledge of current methods
of increasing the natural fauna & flora was
variable throughout the group!
So on a warm morning the teams gathered in the woods. The food for the BBQ
was stashed into the fridge...we were
ready for action.
There were 4 main tasks to complete on
the day; the insertion of wooden poles for
a way marked trail, the design and build
and placement of an Oak Bench, a Charcoal burn and also some light duty tasks
of painting & proofing various wooden
structures around the site.
Equipped with shovels, forks, 6ft oak
poles and a bucket of nails – the way trail
marking teams headed off to the other
side of the wood. Here in teams of 2 or 3,
they had to dig down a spades depth into
the natural clay, the posts were inserted
& the clay rammed home to make good.
It sounds so simple doesn’t it? It actually
involved, laying flat on your front, scooping the earth out with your hands because
the holes had to be so narrow that the
spade couldn’t be used to shovel the
muck out! The folk involved in this managed during the day to insert 34 of the 38
posts that the council had prepared.
A surprise option when we arrived was
the opportunity for a group to be involved
with a charcoal burn. This meant that the
team had to collect and prepare enough
wood to fit into the burner, which was
approximately 1.5 m depth by 1 m diameter. They then had to stack the wood in a
fashion to allow the most efficient burning to allow charcoal formation. The fire
was lit, the lid in place and this was left
to burn for at least 24 hours. After lunch
 | www.acdm.org.uk | Issue 66
this group were then asked to help with
the placement of the oak bench, please
note that the bench was not flat pack
Ikea-style but actually hewn from a felled
oak and was very rustic in appearance. It
also needed to be located over a pond
and permanently placed in site. Given
that the woods are open to the public 24
hours a day, you can imagine that things
like oak benches do occasionally get borrowed... so to avoid this happening the
oversized legs have to be dug down to a
depth over 1.5m with ordinary and post
hole spades. Like the first group, the oak
bench team discovered muscles long forgotten in an office job!
The other tasks completed on the day
consisted of the design and carving of
a picture for the back of the bench and
painting water based preservative on the
window frames of the education centre
and the surrounding fences. Having completed the whole day’s allocation of painting in the morning, this team then went
on to paint the edges of the boardwalk,
the parts of the Hides that required a topup and anything else made of wood that
looked like it could do with an extra coat!
The highlight of the day was the BBQ
– using charcoal made at the site – with
good delegation of the various components everything was present in adequate
supply. The cooking was executed with
a professionalism that hinted at experience although the chefs deny this...
So at the end of the day, a tired, dirty,
but still smiling group of GSK employees left the woods knowing that we had
made a difference to the Biodiversity
of the wood, to the future users of the
wood and to our local community.
Gillian Squire
GSK
The next GSK Stockley Park Data
Management Team’s Community
Day will see them helping out at The
Amazing Great Children’s Party on
the 2nd July. Look out for the writeup in the next newsletter.....
Communications Officer
Association for Clinical Data Management (ACDM)
If you or anyone you know is interested in a flexible working opportunity promoting the
management of clinical trial data, then this may be just the job.
The ACDM needs your expertise to become a ‘hub’ for clinical data management professionals.
The ACDM are delighted to invite candidates to apply for the position of Communications Officer
for the ACDM. The successful candidate will be an enthusiastic, energetic and experienced
communications professional, to help us to drive our public relations initiatives in order to
retain and increase our membership globally and promote all aspects of the ACDM to the wider
industry, using innovative multimedia solutions. These include:
• Annual Conference
• Press Releases
• Training Programme
• Website and Newsletter
• Sponsorship and Advertising
• Special Interest Groups (SIGs) and Technical Meetings
• Other Industry Associations in joint promotional schemes
This part-time contract will initially be for two days/week for a period of 6 months. Working
closely with our sub-committees, we are looking for creative ideas on how we can best promote
the ACDM and give our members the service they need.
Please send a copy of your CV and a one page summary to highlight how you can help us to
achieve these goals. As part of this, please indicate your expectations regarding hourly rate/salary.
The closing date for applications is 15th August 2008.
Submit all applications or any questions to the ACDM using the details below:
Association for Clinical Data Management
105 St.Peters Street, St.Albans, Herts, AL1 3EJ
Tel: +44 (0) 1727 896080
Fax:+44 (0) 1727 896026
Singapore and Thailand
Before 2008, my holidays and travels had only been to European countries, such as France, Spain,
Portugal or Yugoslavia. This was all to change when I was invited to travel further afield to Asia.
A friend and work colleague had left
the company in 2006 to work as a Quality Assurance Auditor in Singapore. We
kept in regular contact and during one
conversation she suggested that I should
visit her. At the time, this seemed unlikely
due to the distance and cost, but, nevertheless, I mentioned her suggestion to
my husband who replied “Why not?”
Her invitation became a reality when I
had sufficient holiday entitlement available, as well as money for my flight, and
my departure was scheduled for 17th
March, returning to the UK on 9th April.
To make things even more exciting, my
friend arranged a five night trip for us to
Phuket Island, Thailand, in the middle of
my stay with her.
After updating some of my travel vaccinations, obtaining currency for both
 | www.acdm.org.uk | Issue 66
Singapore and Thailand, and packing,
my husband took me to Gatwick Airport
for the first part of my journey to Dubai
Airport, where I had about a three hour
wait until my flight to Singapore. Dubai
Airport was extremely hot and a hive of
activity on my arrival around midnight,
but the time soon passed by as I enjoyed
“people watching”.
I was pleased to pass through Immigration at Singapore Airport and receive my
visitor visa – my passport was stamped
for the first time. There was only a small
wait for a taxi and I was soon on my way
to my friend’s Condominium, located
close to Yew Tee MRT Station. The MRT
is the Singapore equivalent of the London Underground, but is a surface train,
air-conditioned, clean (no food or drink
allowed) and always on time.
Arriving at the tower of flats, the taxi
driver realised that there was no flat
number with the address, but luckily my
friend had noticed the taxi draw up and
was soon outside to greet me.
The Singapore weather was extremely
hot and humid, compared to the cold
weather left behind in the UK, so it took a
day or so to become acclimatised before I
ventured out to visit the many attractions.
Apart from the weekends and the five day
trip to Thailand, my friend was working, so
I was on my own to explore Singapore.
I made the obligatory visit to Raffles
Hotel (although I did not have a Singapore Sling as I preferred a glass of iced
Coke), took a short cruise down the River
(even steered the boat), visited Sentosa Island (which is the site of the most
Southernmost point of Asia), Botanical
and Orchid Gardens, Chinese and Japanese Gardens, Bird Park, Chinatown, Little India, Fort Canning Park, Zoo and
Night Safari and many more places.
I visited so many temples that I didn’t
know if I had to cover my shoulders or
remove my footwear. On visiting the
Buddha Tooth Relic Temple & Museum,
I decided to sit in on a service which was
quite an experience as it was so different
to that of the Church of England. It did
mean that I had to return another day to
visit the Museum as the rest of the building was shut by the time the service had
ended. At least nobody seemed to mind
a foreigner being present.
Whilst in Chinatown, I also visited the
Chinese Heritage Centre, which gave an
insight to the terrible living conditions
on arrival in Singapore. One thing did
strike me as interesting though. One man
remembered his childhood days and said
that they were so poor that they could
not afford to see a doctor. If they were
ill, they swallowed a cockroach and that
made them better – not sure if the cockroach was dead or alive though! The fact
that he lived to tell the tale so many years
later must have meant that he survived
this novel treatment. Perhaps it could be
something for a pharmaceutical company
to consider using for a new clinical trial?
The Night Safari was another experience to remember. This was set up so well
that it was great to see so many animals
at night time, viewable from the track in
our open carriage due to subtle lighting
in each area. There was also a section of
the park to walk around to view various
animals in natural enclosures. One highlight for me was walking through the
bat enclosure with bats flying so close. I
had just overheard a conversation that a
woman had been saying about a friend
who had had to have a bat extracted from
her hair, causing her male friend to hesitate and question whether they should go
in for fear of a repeat performance.
One night, my friend took me to St.
James’ Power Station where we stayed
until 3 a.m. at a night club – the resident
live band was great. I also went to the cin-
ema twice which was quite an event for
me as I live in a town with no cinema.
Other days were spent shopping or
just chilling out beside my friend’s pool
provided as part of the Condominium
benefits.
The trip to Phuket Island was wonderful – Thailand was a couple of degrees
warmer than Singapore (around 32-33
deg. C) but the atmosphere was dry and
more pleasant. We booked a couple of
day trips to various islands – we visited
James Bond Island (where Man with the
Golden Gun was filmed), as well as the
location for The Beach, starring Leonard DiCaprio. The guide asked us if we
remembered the big palm tree in the film
of The Beach – she went on to say that
even if we did, we would not see it as it
had been shipped in purely for the film
and removed when filming was over. On
our trips we were able to snorkel from
the beach and also the boat, as well as
travel in a sea canoe and have lunch at
a floating restaurant. One trip finished
up at a centre where we had an elephant
ride and an ox-cart ride. The rest of the
time was spent on the beach, in our hotel
pool (every bedroom had direct access)
and, of course, shopping. My friend was
very good at bartering so that we ended
up with quite a few bargains.
Once back in Singapore, I was able to
continue my travels until, all too soon,
it was time to pack my case once again
to return to the UK and hope that I was
within my baggage allowance – luckily I
was! Once again, I was to spend a number
of early morning hours in Dubai Airport,
but this time I was lucky enough to meet
up with an English lady who was to be on
the same flight so time went by quickly.
After another long flight, spent eating,
drinking, sleeping and watching films, I
was glad to arrive in Gatwick Airport and
be greeted by my husband – who had
missed me!
My memories will live on with the 1400
photographs, which include many taken
of “common flowers” according to my
friend. I also hope to return to Asia one
day so that my husband can also share
my experiences.
Who knows where my travels will take
me next?
Jean Cornhill,
MDS Pharma Services
Issue 66 | www.acdm.org.uk | 
To Study or Not to Study, that is the question...
I completed my 3 year Pharmacology with Management BSc (Hons) at King’s College London in
1998. After hearing the immortal words that all students live for at the time of my final exams
“Please stop writing and put down your pens”, I swore that my exam days were over. After all I
had a very respectable 2:1 and the world of employment was beckoning.
So why in 2006 was I starting a 3 year
part time MSc course in Clinical Research
with 8 hours of exams, 8 essays, more
than 30 article reviews and a 12,000 –
20,000 word dissertation? (not to mention 11-13 trips from Essex to Cardiff for
lectures, exams and vivas). I had toyed
with the idea of further study previously
but the timing was never quite right due
to personal commitments. Maybe it was
my attitude or a window of opportunity
and luck (or another run of Big Brother)
that prompted me to evaluate the pros
and cons of taking on a course in addition to my full time job.
I spoke with a work colleague who was
already one year into the Cardiff University Clinical Research course. She gave
me honest answers to all of my questions and showed me her A4 folders fully
packed with course notes from a wide
range of topics. A further internet search
showed that the Welsh School of Pharmacy has run this MSc/Diploma since
1987 and I was very impressed that the
course was recognised as the gold standard for such courses. “The syllabus is
practice-based and not only reflects the
growing complexity of carrying out global clinical research but covers the recent
technological advances that have taken
place in the industry and keeps abreast
of the ever changing regulatory scene.”
(Quote taken from the MSc/Diploma in
Clinical Research course pamphlet).
Course content included the following (this is only a selection of sub-topics
there were many more):
• Drug Development Process
• Pharmacokinetics and
pharmacodynamics
• Clinical development programme
planning
• Statistical principles in determining
 | www.acdm.org.uk | Issue 66
sample size, randomisation and
analysis
• Clinical Research & Advanced Clinical
Research
• Protocol and case report form design
• Project management
• Regulatory Affairs and
Pharmacovigilance
• Regulatory requirements in Europe,
the USA and Japan
• Health economics;
pharmacoeconomics and quality of
life assessment
• Safety reporting
• Therapeutics: Central Nervous System,
Respiratory Diseases, Cardiovascular
Diseases and Oncology & Immunology
• Pathophysiology, aetiology and
treatment strategies of diseases
• Clinical trial protocol design and
patient selection criteria
• Problems encountered in
conducting clinical trials
• Research Methods & Dissertation
The syllabus is practicebased and not only reflects
the growing complexity
of carrying out global
clinical research but covers
the recent technological
advances that have taken
place in the industry and
keeps abreast of the ever
changing regulatory scene.
Having emailed Cardiff University directly
I discovered that the three year course
was broken up into three distinct sections which could be completed and
then a choice made as to whether to continue-on or exit:
• Year 1: Certificate
• Year 2: Diploma
• Year 3: MSc
Initial investigations on my work Human
Resources (HR) web site and discussions
with my line manager indicated that I
was eligible to apply for sponsorship and
additional days away from work to attend
lectures and exams. Face-to-face discussions with my HR contact confirmed that
as long as I completed a distinct section
of the course I could either continue-on
or exit without having to re-pay course
fees. With a view of taking one-year-ata-time I completed all of the application
documentation and provided to my line
manager and posted to the University
respectively. At the age of 30 I was now
a student again with a student card and
University email address to prove it!
Despite taking less than a 10 year
break from being a University student
things had notably moved on. When I
lived and studied in London I spent many
an hour on the tube train travelling to a
library (usually on the King’s Road) to use
a MedLine CDRom to locate a scientific
paper (which was either razored out of
the journal or located at Guys & St. Thomas’s at London Bridge or the Science
Library behind the Strand).
The Science Library charged 50 pence
per photocopy and no journals could be
removed from the library. So exhausted
and broke I would arrive back at the student house to read the articles only to find
the crucial one was missing so the whole
exercise had to be repeated. However, this
time Cardiff University provided a library
username and password and my workplace had a virtual library. All searches
for articles/journals and even books were
made on the internet and either printed
directly or ordered and provided a couple of days latter as either an email link or
paper copy directly to my desk.
I still feel the pain of booking a London University computer in the computer room and having to sit there through
lunch and boredom so that I did not lose
my typing time. This time I tapped away
at my laptop in my kitchen, in my garden,
at the airport, in India by the pool, and
for want of sounding amazed at technology (and old) very grateful for advancements in computers to write course work.
Although these technological developments did not actually write any of my
eight 1,500 word essays I found that even
with work and domestic commitments I
Hints & Tips on maximising work life balance
• Make course trips into sightseeing excursions by adding an extra day’s holiday
either before or after lectures to visit new places. The route from Essex to
Cardiff can pass through the Cotswolds (great for cream teas!).
• Get to know fellow course mates and meet for dinner, lunch, shopping trips
around course times. Note: Cardiff is good for all three.
• Read the company HR website to see what you are entitled to apply for
e.g. additional discretionary holiday for study days. Ask for the maximum
and negotiate.
• Secure a work laptop computer to allow flexibility in writing essays/articles (I
finished my 2nd year coursework sitting by a swimming pool in Mumbai, India
whilst on a training/mentor project for a total of 9 weeks).
• Familiarise yourself with virtual library facilities (if your company has this
set-up) and enquire if there are any associated costs for ordering papers (as
I was in Research & Development there were no costs to either myself or my
department). Make friends with Google Scholar.
• I scheduled an hour after work for set days to sit at my desk and search for
information using the internet so that I had all of materials/papers that I
needed to sit and write an essay over a set number of weekend hours. Try
and minimise Advanced Time Wasting (ATW) and set yourself deadlines
(I finished my coursework early and went on holiday to South Africa for 3
weeks in the 2nd year).
• I collated previous exam questions into topics and wrote up corresponding
notes during the duration of the course so that I already had revision notes in
a bulleted, straight to the key point format.
• During revision time I used my bulleted key points to create spider type mind
maps and set revision deadlines for previous exam questions to ensure I
covered sufficient topics. I also took up running to get out the house and keep
motivated (in addition to eating lots of chocolate....).
• Increase practical revision. I spoke with people in different work departments
about course areas to expand my knowledge and help to remember key facts
and arguments.
• I kept all work documentation and revision notes packed in one place so that
when I finished my target for a particular day I did not look at any of them.
Create a logical filing system to avoid wasting time looking for notes.
• Investigate possible dissertation topics which fill a work gap and will be
supported by members of your team. As long as your contribution is clearly
stated in your write-up this is an acceptable method.
• Prior to or during dissertation write-up network to find people who are
experts in working with report type templates and in particular formatting.
The cost of buying them a coffee or trading information will save hours of
frustration and throwing of laptop against walls.
had sufficient time to write my essays
and critique numerous articles.
By the time I came to the third year I
had already learnt key skills and could
apply to my dissertation. However, time
management was very important as the
size of the project meant that frequent
time needed to be devoted to ensure a
successful submission. Development and
application of a workable topic was the
hardest part followed by statistical analysis of results. I spent 3-4 months thinking about topic ideas and speaking with
Continued on page 
Issue 66 | www.acdm.org.uk | 
Team Building Exercises
The above heading may bring to mind a vision of tackling a gruelling muddy obstacle course with
unwilling team members or constructing a raft with available (and likely to be insufficient) materials
to cross a stretch of water or surviving overnight on a desolate moor by going back to Nature.
However, there are more civilised ways
to build or strengthen a team without
going to such extreme measures and
participating in such physical and mental
challenges or activities.
Since being employed at MDS Pharma
Services from September 2000, I have
joined in with all but one of the Summer
Events, missing the one due to the date
coinciding with my holiday. Our Summer
Events have been different each year.
One year, we were taken to London
for the day. Armed with a Polaroid camera per team, we were instructed to solve
clues, answer questions and perform
challenges, some requiring confirmation
by instant photo or scavenged items.
Points were awarded for every success,
although showing initiative and being
inventive also scored. I am sure that visitors to London thought us strange at
times – tasks to perform included the
whole team crowding into a phone box
and also one member being “arrested”
by a police officer. Teams entered into the
spirit of things in different ways – some
travelled great distances to find out information and others used the internet or
“phone a friend” options.
One year, we had an “It’s a Knockout” event, which certainly brought out
the competitive nature in some people.
Another year, we had a quiz, when we were
required to dress up and act out our characters in order to gain extra points – I was
in the team called “The Village People” –
need I say more than “hats” and “YMCA”!
The event I missed was a School Sports
Day – with typical events such as the sack,
egg and spoon and three-legged races.
It was a shame as I had been closely
involved with organising this event.
More recently, we went to Legoland
where, again, we had a long list of questions to answer, as well as taking Polaroid photos to confirm certain actions. It
was great going on some of the rides,
although my team was eventually dis-
qualified due to some team members
returning late at the end of the afternoon – could have been due to enjoying
too many of the rides...
Last year, we went to Windsor in search
of the lost Dodo. Similar to the day in London, we had to answer questions and
solve clues, collecting items along the way.
Shoppers were bemused to witness our
team demonstrations of the mating call. At
least we were fairly safe and lucky being in
a strange place not to be recognised!
The typical format of each of the events
includes a meeting, or just a few words
from the Site Manager, at the beginning
of the day, which includes refreshments,
such as a barbecue or buffet meal.
Hopefully, the above has given some
ideas into how team building exercises
can be a source of enjoyment and a social
event to look forward to.
Jean Cornhill,
MDS Pharma Services
Continued from page 
work contacts to obtain input into feasibility. Around this time my immediate
study team suggested a project that they
wanted to set-up and I volunteered to
work on the practical aspects of collating
information and writing up results. Fortunately this discussion was in-line with
my own thoughts and was also perfectly
timed. From this project I created my dissertation on “Challenges of Achieving a
Real Time Clinical Trial Database” and
shared results with both my project and
wider teams. I enjoyed the process of
creating this dissertation and in addition
to the subject of the title “Challenges of
Achieving a Real Time Clinical Trial Database”, I learnt a lot about: online questionnaires; categorical data; report
templates; formatting; temporary binding; hardback binding; embossing and
courier timings.
Personally I have found the whole
experience of taking this MSc very
rewarding and worthwhile. With the syllabus grouped into four intensive four
day modules per annum over a period
of two years this worked well with a fulltime job. Module presenters were passionate and knowledgeable about their
topics and originated from industry,
academia, regulatory authorities, government bodies such as NICE and hospitals. The course was very well organised
and the university contacts were always
available to answer questions and give
advice by email or phone. In addi-
tion I met fellow students from different companies and employment roles
which provided a broader perspective
to course discussions and contacts outside of work. Having just received my
final results, an MSc in Clinical Research
with Distinction, I now have my graduation ceremony to look forward to in July
2008. I would encourage anyone who
is considering further study to consider
the pros and cons and what they would
miss vs. what they will gain.
Michelle Fry, MSc
Principal Clinical Data Scientist
GlaxoSmithKline
 | www.acdm.org.uk | Issue 66
Experiences of Working from Home
As long as I don’t meet the dog going the other way going downstairs, the ‘commute’ to the
office on the days I work from home is very short and stress free! – a great improvement on
the M40 into Greenford; less time wasted and far less tiring.
My working pattern is 2 (sometimes
more) days working from home and
the rest of the week in the office.
The arrangement is such that I vary
my ‘wfh’ days each week as the need
for face to face meetings requires. Of
course, it is also far easier to fit in personal and domestic appointments
on the days when I am working from
home, so equally I vary my ‘wfh’ days
to facilitate those.
Working, sometimes alternate days,
at home and then the office, does mean
I use a computer case on wheels for my
laptop and carry all the documents that
I am working on around with me, as
well. That little case can get very heavy
at times.
Days in the office are necessary for picking up internal post; sorting out expenses
that need a wet signature; conversations
at the coffee machine to pick up on stray
pieces of news; quickly finding someone
and getting a question answered, plus
access to the staff shop (!).
Work on office days rarely starts much
before 9.30 a.m. by the time I’ve got
in, set up my laptop, got a coffee and
unpacked all my folders. I do feel duty
bound to make the effort to see people
face to face rather then calling them, as
I am in the same building, so I may lose
time walking to and from meetings, but
they can often be more productive. Of
course because folks can see I am there
at my desk I may get more people dropping by with ad hoc questions, just
because they can; so I do tend to get
more interruptions. Then at the end of
the day there is that packing up again
before I can set off home.
On working from home days I will
often find myself checking emails whilst
I eat my breakfast, so that I can find my
working day has started before 8.00
a.m., whether I intended it to or not.
Instant messaging means I can almost
as easily spot who is available for a
quick question, and they can spot me! It
is far easier to get work completed that
needs concentration and some uninterrupted time, but equally, without the
promptings of colleagues having a coffee break or lunch, I can sometimes forget to take a break when I am at home.
At the other end of the day I often find
my husband (or the dog) beginning to
suggest it may be time to stop working
and eat!
It does need discipline to keep checking my office phone Voicemail, but I
always leave a message guiding callers
as to where I am working each day, and
my office calendar and email signature
do give colleagues my home phone
number for ease of access.
Would I work from home 5 days a
week if I could? Probably not, there are
some things done better in the office.
However working from home does
require some specific disciplines if home
life is not to get overruled by work.
Jane Tucker
Validation Consultant
GlaxoSmithKline
On working from
home days I will often
find myself checking
emails whilst I eat my
breakfast, so that I
can find my working
day has started before
8.00 a.m., whether I
intended it to or not.
Issue 66 | www.acdm.org.uk | 
International Network of Clinical
“To further the globalisation o
Promotion of collaboration among Clinical D
International forum for discussion of and feedback on
Sweden
Contact:
Email:
Fredrik HANSSON
[email protected]
Finland
FIADM
Finnish Data Management Association
Contact:
Email:
Tiina HARTIKAINEN
[email protected]
The Netherlands
PSDM
Pharmaceutische Statistiek
en Data Management
Contact: Gerald RUITER
Email:
[email protected]
Website: www.psdm.nl
United Kingdom
ACDM
Association for Clinical
Data Management
Contact:
Email:
Eva HAMMARSTROM-WICKENS
[email protected]
Contact:
Email:
David QUARM
[email protected]
Contact:
Email:
Gail KNIVETON
[email protected]
North America
SCDM
Society for Clinical Data Management
Contact: Linda TALLEY
Email:
[email protected]
Website: www. scdm.org
Contact:
Email:
Israel
Contact:
Email:
Japan
Natanya SLOMOWITZ
[email protected]
 | www.acdm.org.uk | Issue 66
Masayuki MAEDA
[email protected]
l Data Management Associations
of Clinical Data Management”
Data Management groups around the world
n current topics of relevance to the discipline of CDM
Denmark
Germany
DADM
Danish Association of Data Managers
DVMD
German Association for
Medical Documentalists
Contact: Mette RAVN
Email:
[email protected]
Website: www.dadm.dk
Contact: Margarete RUDLOFF
Email:
[email protected]
Website: www.dvmd.de
France
DMB
Data Management Biomedical
Contact: Joris CAUQUIL
Email:
[email protected]
Website: www.dmb-asso.org
Switzerland
Contact:
Email:
Stephane ROUAULT
[email protected]
Italy
Contact:
Email:
Cinzia PICCINI
[email protected]
Australia
AHR-DMA – Australasian Health and
Research Data Managers Association
Contact: Allison BROWN
Email:
[email protected]
Website: www.ahrdma.com.au
Spain
Contact:
Email:
Almudena COLINO
[email protected]
ARCS – Association of Regulatory and Clinical Scientists
to the Australian Pharmaceutical Industry Ltd
Contact: Andrew TAYLOR
Email:
[email protected]
Website: www.arcs.org.au
Issue 66 | www.acdm.org.uk | 
Coca Tea Prevents
Altitude Sickness
– the next Clinical Trial?
When you say you’re going on a 3-week holiday most people envisage a relaxing beach holiday
soaking up the sun, interspersed with a few day trips to nearby towns. Relaxing is definitely not
how I’d describe our 3 week holiday in Peru....
We arrived in Lima around midnight and
made our way by taxi to our hotel. It soon
became clear that downtown Lima wasn’t
very appealing – this was reinforced after
driving past numerous cars with bullet
holes in their bonnets! We arrived at the
hotel and found out that we were to meet
the rest of our group at 5.30am the next
morning – not what we wanted to hear
after travelling for over 12 hours.
The following day we boarded Jumbo
(our big yellow bus) and headed south
down the coast to the Ballestas Islands.
Some people call these islands the mini
Galapagos as they’re so full of wildlife
namely seals, penguins, cormorants and
the infamous Peruvian boobys (my hus-
 | www.acdm.org.uk | Issue 66
band Olly found the name of this bird
highly amusing). After lunch we made our
way to Huacachina Oasis, an amazing oasis
surrounded by sand dunes, where we went
dune buggying and sand boarding.
Next stop Nasca to see the famous Nasca
lines and learn more about the Nascan
people. These lines were made over 2000
years ago but were only discovered in the
20th century when a pilot flying over the
plains noticed them. There are a number
of theories as to why they are there. Some
think they enabled the Nascan people to
find water, were special enclosures for
religious ceremonies, a giant observatory
or even a spaceship landing area. Today
the debate still goes on. To appreciate the
lines it is best to take a small plane (and I
mean small, it only fitted 4 people including the pilot). The pilot pointed out the
lines by using the wing tips of the plane as
he banked over them. When he decided
it’d be funny to drop our altitude at great
speed, the expression “stomach in my
mouth” definitely rang true and I must
admit I was almost sick! I’ve included a
picture of the “spider” which is 150 feet
long and is one of the most famous and
impressive of the lines.
The next day we travelled to a place
called Puerto Inca which was one of our
more relaxing days. Our accommodation was in the middle of nowhere next
to the beach so we took advantage, did
some sunbathing and a few people took
a dip in the very cold Pacific Ocean. That
night I tried a Peruvian dish called Ceviche, essentially raw fish that has been
“cooked” in lime juice – I highly recommend it, and surprisingly I didn’t have
any adverse events from it the next day!
Next stop Arequipa; a lovely colonial
city with numerous museums. It also had
a gorgeous “Plaza des Armes” surrounded
by palm trees, and lots of restaurants and
cake shops overlooking the square. Arequipa was at 2400m in altitude so we started
drinking the infamous Coca tea here to
counteract the altitude sickness (I wonder if a clinical trial has ever proven this
works...). We had some free time in Arequipa to look around the museums and in
the evening went to one of the best steak
restaurants I’ve ever been to where I ate
Ostrich steak – delicious!
We travelled to a place called Colca
Canyon very early the next morning
(5am) to see the amazing Condors, which
rise up from the canyon on the thermal
air. Unfortunately when we arrived we
appeared to have missed them riding on
the thermals so all we saw were a few flying high above us, the canyon was still
pretty impressive though! We also saw
the old Inca terraces on the way back
from the canyon. The time and effort
that went into creating these terraces in
the Inca times (15th century) so farming
could be done on the steep hills must
have been incredible.
The next day we headed to Cusco
(3100m altitude), a 12-hour coach journey away. The bad luck from not seeing
the Condors followed us. Two hours into
the journey the bus broke down. Something to do with the brakes and air pressure, the girls didn’t pay much attention!
Luckily we had a mechanic on board and
a few willing volunteers to help him as
there was no mobile phone reception
for miles. The tour leader didn’t seem
to have any back-up plans (which would
never happen at work...). Just as the girls
had come up with a contingency plan,
of flagging random trucks down to hitch
lifts on, the bus got fixed. The front door
was tied shut using someone’s jumper
and we were on our way.
Next stop the Amazon jungle for 2
nights to spot caymans, toucans, monkeys, spiders and giant otters?!?! Our first
adventure was a night walk to spot nocturnal jungle animals. Walking through
the jungle at night jumping at every animal sound was some experience. We
really were a million miles from home,
and the spiders were massive!
The next day was another early start
(4.30am), involving a 10K walk in wellington boots (the jungle floor was very
muddy) to an oxbow lake where a family of giant otters reside. Along the walk
we saw a few animals, but I think most
of them were still sleeping. Our bad
luck continued, we didn’t see any toucans or monkeys on the way and when
we reached the oxbow lake (after staying silent for 30mins – some would say
a record for me) there were no otters in
sight. Piranha fish aplenty though! We
all trudged back wearily to the lodge
and had a well-deserved rest before dinner. Our flight left the jungle at a reasonable hour so we had another half day in
Cusco to explore, visit the markets, sam-
ple Guinea Pig (a delicacy) and also buy
last minute provisions for our 4 day trek
to Macchu Picchu.
The Inca trail. We were finally at the
start and you could feel the air of anticipation within our group. The first day
was fairly easy, all day to do only 10K.
This might sound easy but at altitude it
takes a lot longer than normal, so we
took it at a leisurely pace to acclimatise. Lunch was an amazing spread. The
porters had gone on ahead with all the
tents, food and cooking equipment and
so when we arrived at our lunch spot we
were all amazed. There in front of us was
a proper dining tent, bowls of water to
wash, napkins and fresh juice. Inside the
tent the table and chairs were laid for
what appeared to be a 3-course meal.
The meal was remarkable it consisted of
soup, grilled fish and chips and a chocolate desert, much better than you get in
most restaurants. I knew then that even
with 4 days of hiking I wasn’t going to be
losing weight!
After a hot day of walking we arrived
at our campsite for the first night, had
a well-deserved cup of coca tea and
Continued on page 
Issue 66 | www.acdm.org.uk | 
Continued from page 
admired the breathtaking view.
We woke up the next day with great
intrepidation, as today we would be
climbing over Dead Woman’s Pass. This
pass is 4200m in altitude, which meant
we would be climbing 1200m in altitude
over the course of the day! We decided
to take the day steady and soon found
ourselves near the back of the group
with some other like-minded people.
The camaraderie between groups as we
climbed the final section was incredible,
with everyone cheering us at the top.
When all of us stragglers reached the
top we celebrated with a packet of Prin-
 | www.acdm.org.uk | Issue 66
gles, many sweets and of course numerous pictures...
The way down to the 2nd campsite was
almost as challenging as the climb; negotiating the large steep steps was very
slow going and painful on the knees! We
arrived at the campsite around 3pm and
had a well-deserved rest before dinner.
The 3rd day we all awoke, feeling a little
stiff. We spent the day taking lots of photos, walking through rainforests, negotiating cliff side paths, visiting more Incan
ruins and experiencing the Inca terraces
up close. This was by far the best day on
the trek, partly because the walking was
easier, but also because the views were
outstanding. Dinner was once again delicious and afterwards we welcomed our
hard working porters and chefs into the
tent to present them with their wellearned tips. Early to bed as the wake-up
call in the morning was 4am!
We awoke in the pitch black, tidied
are tents away and excitedly walked for
an hour to the “sun-gate,” which was to
be our first view of Macchu Picchu. For
once luck was with us, as there were no
clouds obscuring the view! We walked
down into the “city” and had a guided
tour around the ruins; during which the
heavens opened, the clouds closed in
and the waterproofs came out. After a
lunch break luck was with us again as the
weather cleared, and we were able to see
the true greatness of the city of Macchu
Picchu. Apparently there is now a petition to make it one of the modern day
“wonders of the world!”
We travelled back to Cusco by train
after buying our obligatory “I survived
the Inca trail” t-shirts. A few beers were
had to celebrate but soon our beds were
calling so we called it a night and had our
first lie in of the trip!
The next day we travelled back to Lima
and we’d come to the end of our trip.
Looking back it seems incredible to see
how much we managed to fit in. Even
though the holiday wasn’t physically
relaxing it was definitely mentally relaxing and I went back to work refreshed
and full of life. I’m definitely going to recommend we use some South American
sites in my next clinical trial so I can get
another trip back there soon.
Carly Baker
Astrazeneca
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If you want to make a difference in global healthcare, Quintiles is the place for you. It’s work worth doing. To apply
for one of these positions, please email [email protected] or apply online via www.quintiles.com/careers
What Does Work Life Balance Mean...!?
A recent survey showed that only 53% of employees found time to take their full holiday
entitlement, with work overload being given as the main cause. 1 in 4 survey respondents
reported that long hours had made them stressed and even depressed.
Working under pressure may be a situation that many of us find ourselves in,
but the consequences of being pushed
too hard are ignored and people need to
shift the balance in favour of family, personal health and fitness.
So Where Do You Start?
You need to take a good look at where
your life is heading and ask yourself
whether you want to continue working
in the same way? Do you spend enough
time with friends and family? Do you give
yourself enough time to recharge your
batteries and unwind? Do you get a good
night’s sleep?
It is a good idea to take a little bit of
time to draw up a plan of an ideal week;
allocating time for: work, leisure, family, partner and maintenance, e.g. House,
garden, car. Wherever possible, make
adjustments as necessary to make the
plan work and to be mindful of making
the best use of your time and to make
time for yourself.
Get Organised
Committing to a little planning and preparation will help you to better manage
your time and keep on top of your job.
At the start of each week set aside 20
minutes to review your diary and bring
up to date with weekly targets, key priorities, deadlines and appointments. From
this weekly plan, collate a daily task sheet
which lists everything you must achieve
and structure each day into a block of activity: grouping phone calls, dealing with queries, reading and responding to emails. At
the end of each day, review that day’s task
list and the next day’s schedule.
Adopting a regular exercise
regime, eating wholesome
food and maintaining a
regular sleep pattern all
help to ensure that we
all maintain a work-life
balance.
Work Flexibly
Flexible and home-working arrangements are offered by MDS Pharma Services, as we recognize that our employees
have busy lives and the ability to have flexibility around start and finish times is an
excellent morale boost and good for our
business. We operate a core hours system
that means that employees must complete their contractual hours and have to
be in the office between 10am to 12 noon
and 2pm to 4pm, this allows employees
to be able to share responsibilities such
as childcare, do the school drop-off, travel
outside of peak traffic times, take time for
appointments and other day to day and
ad-hoc commitments.
We have a number of employees who
Mapping thefuture
8-10 March 2009
Whittlebury Hall Hotel, Northamptonshire
 | www.acdm.org.uk | Issue 66
are based from their home office and
only come to the office a couple of times
a month or for urgent business meetings and their performance reviews; this
allows them to live in more remote areas
of the country or near customer sites
rather than near office locations. Also
we have part-time employees who work
reduced hours per week to give them the
flexibility to work and look after children
or other members of their family, e.g.
elderly parents.
Live Healthily
An essential component of a healthy
work-life balance is to look after your
personal health, keep in a good frame
of mind and be able to switch off. It is
important to develop and maintain interests that are not related to work and need
to be sufficient to take your mind off the
daily grind and to foster good relationships with family and friends.
MDS offer discounted rates at local
gyms and sports facilities or will reimburse up to £100 towards the membership of gym facilities near their home if
they are unable to make use of the facilities near the office base.
Adopting a regular exercise regime,
eating wholesome food and maintaining
a regular sleep pattern all help to ensure
that we all maintain a work-life balance.
Dawn Nottage
HR Manager
MDS Pharma Services GB Limited
Hot-Desking
The advent of desk sharing (or “hot-desking” as it is commonly known) and flexible working
are changing the way in which we all carry out our jobs. Developments in technology like wifi, laptops and Blackberrys now mean that we can all be far more autonomous and flexible in
choosing our work pattern and location.
Flexible working is fairly commonplace
but perhaps less is known about desk
sharing and the benefits this can bring
us as employees.
The premise of desk sharing is that less
desks are provided than there are staff.
Interestingly it is thought that the term
“hot-desking” is derived from the term
“hot-bunking”, a sanctioned practise in
the US Navy whereby more than one crew
member is assigned to a bed to reduce
sleeping space. With one crew member
assigned it was quite possible that a crew
member returning from a shift could lie
down in a bed still ‘hot’ as it has only just
been vacated by another crew member.
Luckily, within the office environment the
effect is much less intimate even if it is
based on the same principle!
An organisation can choose to implement desk sharing for many reasons,
to increase flexibility, reduce costs, and
introduce a new style of culture. We in
the clinical data management (CDM)
team at GSK, have had first hand experience of desk sharing as we transitioned
in July 2007 from the Greenford site to
the Stockley Park site.
Desk sharing has been applied
throughout the building which means
that none of us have ‘fixed’ desks. We
have been provided with laptops and
lockers for personal effects to facilitate
this. Wireless connectivity means that
we can log onto any available work
station and phones at the desks are
accessed by use of a code which links
it to our individual extension number.
Filing space for study documentation
is plentiful and the shared printers are
available which can also be used for
confidential printing. The office space
has been designed with environmental concerns in mind; printers default
The physical proximity
of our therapy area and
study team colleagues has
facilitated a greater level of
interaction, collaboration
and sociability.
to printing double-sided and recycling
points are readily available.
Like any change, it’s fair to say this new
approach to the working environment
was approached initially with trepidation.
When we first learnt about the implementation of desk sharing in the Stockley Park
office there were concerns on a number
of levels, from worries around lack of personalisation of desk space, to concerns
about noise levels and desk availability.
In reality, the transition to this new style
of working environment and it’s outcome
one year on have been far more positive
than any of us imagined it would be.
There is always plenty of space to work
at and additional support is provided via
small meeting rooms and teleconferencing booths. Informal meeting space in
well stocked coffee/deli bars has proved
popular and encourages sociability and
interaction. It didn’t take long for us all
to adjust to the new way of working,
using the lockers, keeping desks clear
and embracing the alternative meeting
spaces.
Two therapy areas moved to Stockley
Park and everyone in the therapy area
has been co-located by floor. The development of these “communities” as they
are called, has been one of the biggest
boons of the move. The physical proximity of our therapy area and study team colleagues has facilitated a greater level of
interaction, collaboration and sociability.
All employees were engaged before the
move on how they wanted their “communities” to look and community representatives had flexibility on planning how to
use the floor space. Both therapy areas
chose to allocate each “sub-community”
(ie; CDM) a certain area and number of
desks so that there was no loss of cohesiveness for each therapy function.
The success of these changes has
been in no small part due to the meticulous planning of the move and forethought in how the desk sharing concept
and communities should be actualised.
Moreover the good quality working environment itself at Stockely Park, that is the
airy, light, spacious feel with good utilities, has also made it an environment
in which we enjoy working. So all in all,
even though desk sharing may not be
suitable for every company and every situation, our experience has been a very
positive one.
Sarah Huggett
Therapeutic Program Manager
GSK
Issue 66 | www.acdm.org.uk | 
article
COLLEGE WEEK
AUTUMN 2008
The ACDM Training Committee is delighted to
publish the schedule for this autumn’s College
Week, which will take place, for the second year
running at Holborn Bars, London from Monday
29 September to Friday 3 October 2008.
Following a complete review of ACDM
members’ training needs, the Training
Committee has developed a blend of new
and revamped courses, which it believes
is suited to all levels of data management
professionals, regardless of their experience and current role.
New courses for College Week
Autumn 2008 are CDISC/CDASH, Transitioning from DM to People Manager,
Managing Offshore Teams, Successful
Implementation of EDC, Working with
Different Cultures, CRF/eCRF design,
Communicating with Non-Technical Colleagues, Impact of Regulations / Guidelines on CDM & Essential Documents,
and a full day of therapeutic area training. All courses have been designed
specifically with the data management
professional in mind and will be delivered by industry experts.
The courses vary from half a day to
two days in length and are all written by people with industry experience, in conjunction with learning and
development experts. This ensures
that they reflect the needs of today’s
data management professionals and
engage people with various learning
preferences. The courses are highly
interactive and include a variety of
trainer input, group activities and personal reflection. All participants will
be encouraged to interact with eachother, contribute to group discussions
and share their experiences.
As always, College Week is also a great
opportunity for data managers to network with fellow professionals, share
ideas and discuss data managementrelated issues and Holborn Bars provides
excellent surroundings to do this in.
The courses represent excellent value
for money, with discounts being offered
for early bookings and for multiple course
bookings (the more you book, the more
you save!)
An overview of the courses is provided opposite. Delegates are welcome
to attend any of the courses detailed.
However, the coloured n indicate our
suggestion of the courses we believe
would be most suitable to each level
of experience.
Fundamental n
Individuals with limited or no experience in DM.
Intermediate n
Solid experience in core DM tasks e.g. Data Review, Discrepancy/Query
management.
People Manager/Project Manager n
Demonstrated experience of set-up, conduct and close-out and seeking to
develop team leadership and people management/project management skills.
Technical/Specialist n
Looking to develop technical expertise in DM activities.
Full details of courses and how to book can be found on the website
www.acdm.org.uk
 | www.acdm.org.uk | Issue 66
article
MONDAY
TUESDAY
29 September
30 September
Fundamentals of
CDM
n
Fundamentals of
CDM
This two day course
provides a broad
understanding of clinical
data management
fundamentals; set within
the context of the drug
development process.
This interactive course
introduces participants to
the processes, concepts
and terms used in clinical
data management.
n
This two day course
provides a broad
understanding of clinical
data management
fundamentals; set within
the context of the drug
This interactive course
introduces participants to
the processes, concepts
and terms used in clinical
data management.
Project
Management
n
Appreciation of
Statistics
n
This one day workshop
aims to equip Data
Managers with the
technical project
management skills
they need to effectively
plan, track and manage
clinical trial studies.
The methodology and
techniques taught
in this course can be
applied to any project
management situation.
This one day course
is suitable for all data
managers who interact
with statisticians and
would like to learn
more about their role.
The course provides
Data Managers with
an appreciation and
understanding of the
types of statistics used
in clinical trials.
Transitioning from
DM to People
Manager
n
This one day course
provides an overview of
the role of leadership
with a data manager
context. It will assist
Data Managers in
determining how their
role will/has changed
and what is required of
them when leading and
working with others.
Managing
Offshore Teams
n
This half-day course
(am) will assist
data management
professionals with
line management or
project management
responsibilities in
motivating and
communicating
effectively with
remote workers.
Working with
Different Cultures
n
This half-day (pm)
course provides an
opportunity for senior
data management
professionals to discuss
some of the challenges
they experience when
working in a multicultural environment
and find ways of
making a positive
impact when working
with other cultures.
WEDNESDAY THURSDAY
1 October
Therapeutic Area
Training for CDM –
Oncology
nnn
Half-day (am or pm). An
insight into the science
of the disease area, the
types of data and reasons
for collection and the
challenges these pose.
2 October
3 October
Interpersonal
Skills for DMs
nn
CRF/eCRF Design
n
This one day course
provides a broad
interpersonal skills
needed by clinical data
managers in order to
work effectively as part
of the project team.
Therapeutic Area
Training for CDM
– CNS
nnn
Therapeutic Area
Training for CDM –
Anti-infectives
nnn
Successful
Implementation
of EDC
n
This one day course
provides an overview of
electronic data capture
and its uses in the drug
CDISC/CDASH
n
A half-day course (am)
for people looking
to develop technical
expertise in DM activities.
Details being finalised.
Communicating
with NonTechnical
Colleagues
n
This half-day course (pm)
looks at why it can be
difficult to communicate
technical information
to non technical
colleagues. Participants
will learn techniques
for improving their
communication skills.
FRIDAY
People & Team
Management
n
This one day
course will enable
data management
professionals to
develop the people
management skills
they need to effectively
manage a team.
This one day course
provides a broad
considerations needed
when designing or
reviewing paper or
electronic CRFs. Through
presentations and
interactive workshops,
participants will gain an
appreciation of the
problems associated
with inappropriate CRF
design, an insight into
the requirements of
CDISC and CDASH and an
understanding of how to
design effective and
efficient CRFs.
Impact of
Regulations/
Guidelines on
CDM & Essential
Documents
nnn
This one day course
provides an insight
into how current
regulations and
guidelines need to be
applied in the data
management arena
in order to ensure
effective compliance
with relevant laws.
Managing
External Data
n
This one day course
provides data managers
with an understanding
of the different types of
external data that they
might come across in a
trial and how to handle
both the data and the
provider. We will also
discuss the specific
challenges of electronic
laboratory data and its
potential impact.
Issue 66 | www.acdm.org.uk | 
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article
Tips for Working as a CDM Contractor
Anyone who has worked in Clinical Data Management in the past decade has likely worked on
project teams with contract workers, as it has become increasingly common for companies to
use short-term contractors.
For CDMs who have spent their entire
career working as an employee, it may
come as a surprise that many of their colleagues prefer contract work to “permanent” employment.
While the reasons that an individual may
decide to join the contracting workforce are
varied, there are many potential benefits
to working as a consultant including flexible schedules, varied work assignments,
and even potentially higher income.
Some contractors seek assignments that
provide opportunities for travel, while
others become contractors specifically to
reduce or avoid travel altogether. Contract work can often accommodate life situations that require a flexible schedule
which cannot be easily accommodated
in the often hectic, long work days of the
typical data management department.
Likewise, many contract assignments are
a result of life situations that require existing employees to be temporarily replaced
or to fill a critical short-term need. “Typical” contracts may include temporary
replacement of an employee on leave
(medical, family or military), completion
of a database lock, or validation of a software upgrade. Work may be performed
either on-site or off-site (or frequently a
combination of the two) depending on
the needs of the particular project.
The obvious first step for the potential contractor is finding the right initial
assignment. In some cases, this first contract may be with a current or previous
employer. If this is not the case, then
establishing a relationship with a good
recruiter is a useful step towards finding
a successful initial contract. Locating a
contract assignment is often a matter of
being in the right place at the right time
and a good recruiter’s network keeps
him/her aware of such opportunities.
Short-term opportunities are frequently
not advertised, but may result from a
casual comment by a hiring manager
to a recruiter that they “could really use
someone to revise our SOPs” or “someone to train our new CDM hires without taking existing staff off their current
projects.” Building relationships with
good recruiters – and keeping them
updated as you acquire new skills and
experience – will help ensure that your
name comes to their mind when suitable opportunities arise.
A true consultant has the
background and experience to
make high-level contributions
to client project teams that go
beyond performance of a list
of job duties.
Once you are established as a contractor with a solid reputation for quality work, opportunities for new contracts
will sometimes present themselves.
There may be an opportunity for a repeat
assignment with a company with which
you have worked previously or an assignment at a new company to which someone you worked with previously has
moved. In today’s mobile industry, it is
not unusual to work with the same individual at two or more companies over
time. This emphasizes the need for a contractor to build and maintain strong relationships and not to “burn bridges” with
former employers or colleagues.
Networking is another important source
of potential contracts. Networking can be
as simple as having drinks or dinner with
former coworkers or otherwise keeping in
touch regarding opportunities of mutual
interest. Participation on task forces and
committees for industry groups, such as
SCDM, can be a fun way to build relationships with colleagues from across the
country and beyond while providing a
boost to your resume and helping to build
resources that can be of use to us all.
There are numerous options for networking via the Internet, from industry websites that list jobs and position
wanted profiles to sites, such as LinkedIn,
that are specifically designed for professional networking. Local and regional
industry groups, such as SAS or Oracle user groups or local pharmaceutical
industry groups, are another excellent
way to make contacts in your city or
region while receiving training that can
be useful in your daily work.
A frequently heard pitfall of leaving the
world of the corporate employee is lack
of benefits. Traditionally, contract assignments have not provided benefits such as
paid vacations, tuition reimbursement,
401k and health insurance. In the current
strong CDM job market, this is no longer
necessarily the case. The availability of
benefits and the specific benefits package
available will vary widely between consulting firms. While there are firms that
treat consultants as full employees with
paid holidays, sick leave, vacations, and
health insurance, there are other firms
that provide no benefits at all. The key to
finding the right personal situation is to
do your homework. Research agencies in
your area, ask your colleagues and speak
personally to several firms to determine
what best meets your needs.
Some potential contractors fear that
taking a series of short-term opportuniContinued on page 
Issue 66 | www.acdm.org.uk | 
article
Continued from page 
ties will brand them as a “job hopper”
who is unlikely to stay with any one company for an extended period of time.
In reality, the reaction of future potential employers to your work background
will depend largely on how you shape
your career and present your experience. Career mobility is common in the
fast-moving modern world of clinical
research.
While a series of seemingly haphazard
short-term assignments may not impress
a hiring manager, a resume of progressively more advanced contracts providing
experience in a variety of companies can
increase your attractiveness to a prospective employer and will help you make the
leap from “contractor” to “consultant”.
While the terms “contractor” and “consultant” are sometimes used interchangeably, there is a critical difference. A true
consultant has the background and experience to make high-level contributions to
client project teams that go beyond performance of a list of job duties. A consultant has considerable knowledge in his/
her areas of expertise and the necessary
breadth and depth of experience to see
the “big picture” perspective. Consultants
are valuable to clients who are seeking to
improve their work processes and may be
used for such mission-critical assignments
as writing or revising SOPs, managing critical projects or creating staff training programs. It is not unusual for experienced
consultants to build their careers around
such a particular area of expertise.
Training is another area that is essential to the contractor but may require
some initiative. While it is common for
data management employers to pay for
on-site and off-site training, this type of
paid training is frequently not available
to contractors.
Even in instances where paid training is
provided by a contract agency, such training will usually take place outside of paid
work hours. At the same time, the very
nature of contract work makes it essential for contractors to keep their skills as
up-to-date as possible, and it is, therefore,
 | www.acdm.org.uk | Issue 66
necessary to be aware of cost-effective
and time-efficient training opportunities.
As mentioned earlier, local SAS, Oracle
or other industry user groups can be an
excellent source of training. Such local
training avoids the costs of travel and
extensive unpaid time away from work,
and such programs are generally free or
very low cost compared to commercial
training courses. Local community adult
education or university continuing education programs can also be an affordable source of medical, science, software
or business training. Books and online
tutorials are another excellent source of
education that have the added advantage of allowing study in the evening or
while commuting rather than requiring
Participation on task forces
and committees for industry
groups, such as SCDM,
can be a fun way to build
relationships with colleagues
from across the country and
beyond while providing a
boost to your resume and
helping to build resources
that can be of use to us all.
attendance at scheduled classes.
Attendance at SCDM and other industry
conferences should certainly not be overlooked. Conferences are an excellent way
to say informed about new industry trends
and provide excellent opportunities for
networking. It is hard to match the breadth
and depth of knowledge – and the industry contacts – that can be gained in such
a short period of time. The person sitting
next to you in a session or at lunch may be
seeking a consultant with just your skills!
Since it is likely that conference-related
expenses will not be paid for you as a contractor, scheduling conference attendance
in conjunction with a vacation may reduce
costs and help make such a trip attainable.
Last, but certainly not least, it is important not to overlook opportunities for onthe-job learning that are common in our
daily work. When seeking new contracts,
don’t be afraid to seek projects that are a
“reach” or that otherwise take you outside
of your current comfort zone. The typical experienced CDM has knowledge of
medical terminology, adverse event coding, serious adverse event reconciliation,
database management and clinical trials regulations (among other areas), but
may never consider taking a contract in a
pharmacovigilance group or as an on-site
or off-site study monitor. There are many
industry opportunities that utilize some
or all of your CDM skills and could benefit
from the contributions of an experienced
data manager. Spending time outside of a
traditional CDM role can be a great learning experience and result in new skills
that are useful in future work.
All things being equal between two
potential contract opportunities, it is worth
considering the opportunity that will provide additional learning experiences. Consider the contract with the company that
uses a data management software system with which you have no experience.
Accept a contract in a large pharmaceutical company if your previous experience
has been exclusively in small biotech companies. Such variety keeps the work day
interesting and provides another set of
valuable skills for your resume. While on
the job, take initiative to increase your
repertoire of skills. Volunteer for projects
that will teach you new skills or that will
allow you to work with a department with
which you do not often have contact (e.g.
regulatory affairs or quality assurance).
In summary, work as a contractor is a valuable option for many Clinical Data Managers. Whether contracting is a life-long
career choice or a temporary situation, wise
contact choices can be a positive career
experience and can increase the work skills
and quality of life of the contractor.
By Kenneth Milstead
Article reproduced, with the author’s
permission, from the Winter 2007
edition of SCDM’s Data Basics.
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article
eDC in An Early Phase Setting
Early phase clinical trials should be simple. The questions we are answering are not
complicated. “Does it hurt?”, “Does the drug get to the parts that matter?” and “What
dose do I need to administer to attain the desired activity?”
Early phase clinical trials might be classified as phase I or phase II, or some combination thereof but, however these
assessments are performed and managed,
they provide the clinical data that critically
decides whether any drug candidate will
enter wide scale efficacy trials.
I started in data management 15 years
ago when Electronic Data Capture (EDC)
was a developing yet still relatively rare
entity. Paper CRFs ruled supreme. My first
post-University job was in a large Pharma,
phase I data management group where
the CRF was designed from standards
and printed the week before FPFV. The
database was built and ready to go for
when the first CRF pages came in house
and, 4 weeks after LPLV, we locked the
database. Life really was that simple.
”A complex system that works is invariably found to have evolved from a simple
system that works.” John Gaule
Today, with the advent of the iPod generation, EDC is the new standard in our
clinical trials toolkit and it is taken as read
that timelines have been shortened and,
therefore, that we achieve more with
less. Database deployment is simple and
readily achieved prior to FPFV, and database lock is always the same day as LPLV.
And yet, today we hear of disgruntled
Sponsors who are abandoning EDC in
early phase trials and returning to paper
based CRFs. What possible reason could
there be? Could it be that EDC has failed
to deliver in these early phase studies?
Could it be that paper CRFs remain the
way to go?
I see the problem from a slightly different angle, challenging the tools not
the philosophy – Is it simply that one system does not fit all? Why should it be
 | www.acdm.org.uk | Issue 66
true that a system that brings us success
in phase III is pre-determined to bring
us success in phase I? No reason at all –
the traditional web-based systems with a
history in later phases are hampered by
one simple fact, they struggle to manage
non-eCRF data.
A new generation of solutions is required,
systems that manage biomarker data, lab
data, eCRF data and every possible data
that we could be asked to manage.
What is clearly needed
is an electronic solution
based around a single
data acquisition and
cleaning database that
unifies the whole clinical
data ecosystem, from
Pharma companies or their
CROs, to clinics, to central
laboratories, including
biomarker values.
A New Way
Early phase clinical development
(EPCD) is becoming increasingly important as sponsors seek to “kill off” weak
candidates early, and to reliably predict
the efficacy of compounds in the clinic,
increasingly based on biomarker data,
while monitoring study data for any telling safety signals. The ability to realise
the full potential of early phase clinical studies depends upon their effective
operational conduct. A particular area of
concern is the collection and accumulation of data from multiple sources into
a single database so that overall study
analyses can take place in a timely way.
Given the multiple sources, this aspect of
a study can take as long to complete as
the clinical phase itself.
Indeed, as the speed and sophistication of analytical systems improve, the
handling of clinical, biomarker and pharmacokinetic data and the collation of
those data can become a major source of
delay or at least a significant rate limiting step in the completion of each study.
The area of data acquisition and management is also expensive, requiring a
significant number of skilled people to
complete these tasks accurately.
eDC has long been hailed as a solution
to all our troubles, but there are some
chinks in the armour. Firstly, speed. If it
takes 12-15 weeks to build the database,
this element becomes the rate limiting
step. So what of time savings at the database lock end? Are we really locking databases the same day the last patient leaves
the clinic? Or have we simply re-generated our classification of what constitutes
a database lock? With a traditional frontend, back-end approach to data collection and management, the final stages of
data cleaning have frequently been classified into what is essentially just subtasks of the traditional database lock.
First we “soft-lock” or “freeze” the eCRF
data, then we merge the external data
(PK, Central Labs, etc.) over the next few
weeks, and after a final round of cleaning we declare database lock 4 weeks
later. So, in brief, if we compare this performance to a paper CRF, it takes longer
to set-up and longer to lock.
Another consideration is the impact
on the clinical pharmacology units (CPU)
that frequently perform these projects.
The requirement for timely data accrual
has led to the development of electronic
study management systems that include
article
aspects of both clinical data acquisition
and management. These systems are typically found in CPUs owned and operated
by pharmaceutical companies, although
some CRO operated CPUs are similarly
equipped. The development and use
of such sophisticated IT systems can be
costly and also tends to reduce flexibility
such that many CRO CPUs opt to reject
new technology in favour of traditional
paper CRFs. Even when such electronic
data acquisition systems are in use, some
are not 21CFR11 compliant and others do
not allow for sophisticated data management and easy loading of laboratory and
biomarker data. Notionally, it is possible to use eDC systems intended for later
phase clinical development in an EPCD
setting to address some of these issues,
however some sponsors who have tried
this strategy report that the set-up phase
of each study is extended, the ability to
amend protocols (and eCRFs) at short
notice is removed and the loading of laboratory data difficult. These observations
suggest that there is a need for a more
sophisticated, regulatory compliant, flexible electronic system that replaces paper
and is specifically intended to acquire and
manage data in the particular setting of
early phase clinical development.
As EPCD studies can be carried out in
many types of unit or clinic, the requirements for a data acquisition and management system are not always the same. In
the following section an overview of possible requirements for such a system in a
variety of scenarios is suggested:
1) Single centre, EPCD studies with
healthy subjects
• Fast database build and amendment
to allow for seamless adaptive trial
design studies.
• Quick and easy to use at the bedside
or in the CPU – instant page turns for
clinic staff.
• Real time view of data by Principal
Investigator and sponsor for possible
safety issues
• Direct data capture from medical devices
(ECG, BP, psychometric devices etc).
• Load data direct from lab data systems
(clinical chemistry, haematology,
biomarkers, drug concentrations in
blood etc).
• Small IT footprint within clinic;
greatest flexibility would be gained
by working wirelessly rather than
through the clinic’s wired IT network.
• Wireless communication to allow
data acquisition and communication
anywhere in the CPU, clinic or
hospital.
• Ability to conceal some data fields
from specified users (preserve study
masking).
• Real time data validation checks to
enhance data quality, coupled with
ability to code data (medical history,
AEs, concomitant medication).
• Overall low cost of system
maintenance and training for
temporary, short term contract or
bank staff.
• Full audit trail for all data entries.
• No password nightmare – use
biometric finger prints instead of
passwords.
2) Single centre, EPCD studies with
patient populations
• The items listed in (1) above plus:
• Ability to acquire data wherever
patients can be assessed most
conveniently for (a) the physician
screening the patient and (b) the
patient to attend (without regard
to the local IT infrastructure/ web
access).
• Allow investigators to review
screening data immediately it is
available so that they can quickly
resolve any patient enrolment criteria
questions.
• Allow sponsors to see patient
screening data in real time to confirm
suitability of a patient to be included
in a study.
3) Multi-centre, small studies with
healthy subjects or patient populations
• The items in (1) and (2) above plus:
• The ability to review data collected
from a multiple locations as it is
acquired from the patient/ healthy
subject.
All these types of study require the data
management system to be configured
and deployed quickly (within the typical
4 week time frame for an ethics committee or IRB meeting schedule). Further to
that, if the study design changes or the
schedule of study procedures changes,
this should be reflected in the eCRF
within hours. This aspect is of particular
relevance for those sponsors involved in
experimental medicine who may include
adaptive design/ Bayesian statistics in
their studies, as they may wish to either
(1) adjust randomization schedules to
change treatment arms as each study
progresses or (2) use study designs that
include the conduct of an exploratory
phase within a study that immediately
leads into a confirmatory phase. In this
latter situation flexibility to immediately
alter the confirmatory part of the study
in response to the exploratory phase
allows the sponsor to gain time as well
as insight from the study design.
The requirements above also point
to the need for the technology to support the use of eSource methodologies
in which data are captured directly into
the study database (including direct data
capture from medical devices) without
the interim step of recording the data
on a paper CRF or study work sheet.
This approach is intended to save time
Continued on page 
Issue 66 | www.acdm.org.uk | 
article
Continued from page 
and eliminate transcription errors. The
method does not eliminate the need for
study physicians to maintain progress
notes of their patients if the study is
being conducted in a patient population,
but it does make the electronic record
the study source data.
If these requirements were met by a
robust system few would argue that the
operational conduct and reporting of
EPCD studies would be faster and more
investigator friendly.
Where to Start
Cmed recently invited a number of Industry experts to take part in workshop
designed to tackle these issues head on.
Unsurprisingly, the feedback we received
supported the discussion outlined above.
What is clearly needed is
an electronic solution
based around a single data acquisition and
cleaning database that unifies the whole clinical data ecosystem, from Pharma companies or
their CROs, to clinics, to central laboratories, including biomarker values etc.
This simplifies the problem by obviating or automating whole process steps
and further it is capable of being simply
configured to work flexibly in any data
acquisition capacity, allowing direct
data capture from medical devices and
direct downloads of lab data into the
study database.
The single system strategy offers a new
approach to the acquisition and management of EPCD clinical trial data. The strat-
egy to build a “fit
for purpose” solution has been taken
forward and developed into a fully functional and validated system
that is in use today.
In addition recent hardware advances
provide opportunities to use commercially
available hardware specifically intended
for use in hospitals and clinics shown
above. The introduction of this hardware
has further developed the vision of a purpose built clinical trials appliance that ideally fits in with clinic work flows, replaces
paper CRFs and moves clinical data acquisition into the 21st century.
Richard Young
CMed Research
THE NEW ACDM WEBSITE UNWRAPPED
 | www.acdm.org.uk | Issue 66
get
Don’t for he
out t
to check
for
regularly
website es, Events,
dat
News Up s and Prizes
ion
it
Compet cdm.org.uk
w
at ww .a
To have your profile featured email [email protected]
ACDMpeople
Championing and Supporting Initiatives
NAME: David Smith
ACDM POSITION: Co-Chair Clinical Research Computer System Validation Working Party
COMPANY: Head of Validation Services, Roche Products Limited
Dave has worked in the pharmaceutical
industry since 1979 when he joined
The Boots Company in Nottingham.
Beginning as a Quality Control (QC)
Laboratory Technician in Gas Liquid
Chromatography and Raw Materials
Analysis, Dave moved on to join QC
Microbiology in 1982.
Joining the Boots Biocides Group in
1985, Dave continued his work as a
Microbiology Lab Technician and in 1988
moved to the administration function as a
Regulatory Project Planner. Here, dealing
with the assembly and submission of
technical and regulatory dossiers, Dave
maintained and extended approved uses
of Biocides on a worldwide basis dealing
with, amongst others, the EPA and FDA in
the United States.
In 1992 Dave joined the IT section
of Boots that dealt with the provision
and support of services to the preclinical safety sections and this marked
Dave’s introduction to GLP, GCP and
GMP regulated environments. Initially
working with VAX/VMS systems this
soon expanded into support of personal
computers in what is now recognised
as a traditional office and laboratory
networked computerised environment.
Working with QA and client
departments, Dave worked on
numerous computerised system
validations for departments including
Pathology, Toxicology, Helpdesk and QC
Laboratory Information Systems.
In 1995 Boots Pharmaceuticals was
acquired by BASF and became Knoll
Pharmaceuticals and Dave’s duties
broadened into IT project management
and infrastructure support and planning.
Dave joined Boots Retail International
in 2000, working in support of
management decision tools,
warehousing and EPOS systems until
February 2001 when he joined Roche as
a senior systems validation analyst.
Along with the other members of
the 2001 CR-CSV working party, Dave
was one of the contributing authors to
the 2nd edition of the Computerised
Systems Validation in Clinical Research,
A Practical Guide.
Now reporting to the Head of Quality
Validation as the Head of Validation
Services, Dave is responsible for assisting
the Roche Pharma business with manual
and computerised system validation in
a multi-regulatory (GxP) environment.
Also trained as an Electronic Records
Management (ERM) Practitioner, Dave
is actively championing and supporting
initiatives within Roche and is an active
speaker at many forums with regard to
CSV, Archiving, EDC and ERM.
Dave will also be an active participant
at the upcoming DIA continuation of
the Red Apple initiative (Red Apple II /
Peach).
Senior Clinical Data
Managers Forum
Offshoring Strategies within Clinical Data Management
Novartis Foundation, London
Wednesday 8th October, 2008 • 13.00 – 21.00
The actual forum will be from 13.00 – 18.00, with
registration from 12.30 and dinner from 18.30 – 21.00
Vanessa Tierney, Global Head, ClinPharm Data Sciences
(CPDS) Development Operations, GSK will be the Keynote
speaker at this forum and will present the business case for
having an offshoring strategy. This will be followed by a
discussion of how such a strategy is being implemented in
both CRO and Pharma companies.
Issue 66 | www.acdm.org.uk | 
ACDMpeople
To have your profile featured email [email protected]
The 5th Career
NAME: Jane Tucker
ACDM POSITION: Co-Chair Clinical Research Computer System Validation Working Party
COMPANY: Validation Consultant, GSK
Working in the Pharmaceutical
Industry in Data Management could
be thought of as my 5th career (that
comes of being old!). Having started
my working life with Glaxo in virus
vaccine manufacturing, I then moved
to Pathology as a Microbiologist before
a period as a Mum (and Tupperware
Manager!). Once the children were
both in school full-time I went back
to labs – but this time as a school
lab technician; and then finally, once
my two sons could cope without me
being around during school holidays,
I started looking for my last ‘career’.
With Pathology on my CV, I eventually
found Gill Lawrence offering to take me
on and train me in Data Management
at Searle, because I would be someone
who ‘understood lab data’!
I readily got to grips with all that data
management involved and found that
this was a disciple that I enjoyed, but,
via ACDM activities, also discovered
the developing discipline of ‘Computer
System Validation’ in the early 1990s.
Having been part of the team at Searle
developing and validating their in-house
developed CDM system – SWAN – I
then proceeded to concentrate more
and more on CSV, and less and less on
routine Data Management. I moved
from Searle to Innovex, and then on to
Wyeth, with an increasingly CSV and
Quality role, within a DM environment.
In parallel with this work I was also
a founder member in 1995 of the
ACDM-PSI Computer System Validation
Working Party, tasked, by the ABPI,
with writing a guidance document for
the pharmaceutical industry on CSV
within a Clinical Research, rather than
manufacturing, context.
By 2001 I was working for GSK, first
based in Harlow, and then in Greenford;
where my role was initially 100% CSV;
but over time, as various regulatory
expectations for ‘a risk-based approach’
developed, the ‘risks’ aspect of my
responsibility has almost overtaken the
CSV aspect. I also now have a Business
Continuity Planning responsibility,
possibly because I couldn’t think of a
good enough reason why someone else
was better qualified than me to take on
this vital, but fairly thankless, task!
CR-CSV Meeting
CR-CSV WP is in action again and plans are underway for a new
groundbreaking publication – CR-CSV Light. This book will be aimed
specifically at small niche clinical research suppliers and academic
institutions, for whom the large corporate guidances on CSV are beyond
the scope of their limited resources. We are planning a Working Forum
for 14th November 2008. We need ACDM members to approach their
individual niche and academic suppliers to ensure that they get the
details of this session once the flier is available, and intend this to be
a working session to allow those present to help define the necessary
contents for this new venture.
CR-CSV Meeting • 14th November • Kingston Smith, Goswell Road, London EC1M 7AD
 | www.acdm.org.uk | Issue 66
The ACDM-PSI Computer System
Validation Working Party eventually
became the Clinical Research Computer
System Validation Working Party and
produced version two of the guideline
and by 2008, for the second time, I find
myself chairing the group, as we work to
plan version 3!
Outside of work, I am a Mum to
two, now grown-up, sons, and now
a daughter-in-law as well. I live in
High Wycombe with my husband Bob
and our Staffie/Rhodesian Ridgeback
crossbreed dog, called Barney, who is
an 18 month-old bundle of excitement
and energy! I love working with
children in my role as Youth Team
leader at church, and also make all
my own greeting cards, including
working in partnership with Bob to
produce 150+ hand-made Christmas
cards each year! I have also now caught
my husband’s enthusiasm for steam
trains and we are both volunteers with
the preserved Chinnor and Princes
Risborough Railway Association, where
I can be found manning the booking
office on occasions!
diary
For more details of ACDM events, visit www.acdm.org.uk. SEPTEMBER
OCTOBER
DECEMBER
21-24
6-8
4-5
SCDM
Fall Conference
Hyatt Regency Dallas at
Reunion Dallas, Texas
eClinical Forum
eClinical Forum Autumn
Meeting
Brussels, Belgium
29-30
8
DIA
9th Conference on European
Electronic Document
Management
Barcelona, Spain
ICR
European Conference
and Exhibition
Budapest, Hungary
29-3 Oct
ACDM
College Week
Holborn Bars,
138-142 Holborn, London
OCTOBER
5-8
ISoP
8th ISoP Annual Meeting
Buenos Aires,
Argentina
6-8
TOPRA
5th TOPRA Annual
Symposium
Budapest, Hungary
ACDM
Senior CDM Forum –
Offshoring Strategies within
Clinical Data Management
Novartis Foundation, London
20-23
DIA
2nd Annual Clinical
Forum – Data Driven Drug
Development Decisions
Ljubljana, Slovenia
29-31
BARQA
2nd Global QA
Conference 2008
Edinburgh
NOVEMBER
14
ACDM
CR-CSV Meeting
Kingston Smith,
Goswell Road,
London EC1M 7AD
FEBRUARY 2009
ACDM
Senior CDM Forum
TBD
MARCH 2009
8-10
ACDM
Annual Conference
Whittlebury Hall,
Northamptonshire
17-18
ICR
30th Annual Conference
and Exhibition
ICC, Birmingham
8-10 March 2009
Whittlebury Hall Hotel,
Northamptonshire
DIA
21st Annual Euromeeting
Berlin, Germany
For BARQA events: www.barqa.com
Tel: +44 (0) 1727 896080
Mapping
the future
23-25
For ACDM events: www.acdm.org.uk
St Albans, Herts AL1 3EJ
Monday 29 September to
Friday 3 October 2008
Holborn Bars,
138-142 Holborn, London
25
For ACDM events contact:
105 St Peter’s Street
COLLEGE WEEK
AUTUMN 2008
For CR-CSV events: www.cr-csv.org
For DIA events: www.diahome.org
Fax: +44 (0) 1727 896026
For eClinical Forum events: www.eclinicalforum.com
For ICR events: www.instituteofclinicalresearch.org
For ISoP events: www.isoponline.org
Registration forms for ACDM events will be sent out to each member
approximately three months prior to each event.
For MHRA events: www.mhra.gov.uk
For PSI events: www.psiweb.org
ACDM membership can be applied for via the internet
For SCDM events: www.scdm.org
at www.acdm.org.uk, or call the ACDM Office for an application form.
For TOPRA events: www.topra.org
Issue 66 | www.acdm.org.uk | 
105 St Peter’s Street, St Albans, Herts AL1 3EJ
Tel: +44 (0) 1727 896080 • Fax: +44 (0) 1727 896026
Email: [email protected] • www.acdm.org.uk
ACDM DIRECTORS
Chairperson David Baker
Chiltern International Ltd
Tel 01753 647802 Fax 01753 647879
Email [email protected]
Vice-Chairperson Fred Daniels
Premier Research Limited
Tel 01344 752375 Fax 01344 752374
Treasurer Lisa Goodwin
AstraZeneca
Tel 01625 518832 Fax 01625 514900
Secretary Paul Fardy
Eisai
Tel 0208 600 1400 Fax 0208 600 1479 Email [email protected]
Tracy Fells
CMed Research
Tel 01403 755095 Fax 01403 755051
Sue Gales
Wyeth
Tel 01628 413893 Fax 01628 413862
Ian Pinto
Roche Products Ltd
Tel 01707 365904 Fax 01707 384513
Harshad Sodha
Omnicare Clinical Research
Tel 01403 823064 Fax 01249 444189
David Walpole
GlaxoSmithKline R&D
Tel: 01279 644501 Fax: 01279 644848
COMMITTEES
Conference Tom O’Leary
ICON Clinical Research Tel +353 (0) 1 291 2439 Fax +353 (0) 1 291 2717
International Collaboration Eva Hammarström-Wickens Tel 0115 948 7116 Fax 0115 948 7119
Orion, UK Email [email protected]
Newsletter Jon Milton
Pfizer Tel 01304 645788 Fax 01304 652218
Email [email protected] Public Relations Ian Pinto
Roche Products Ltd
Tel 01707 365904 Fax 01707 384513
Technical Meetings Chris Cramer PharmaNet Ltd Tel 01494 896248 Fax 01494 896261
Training Jacqueline Johnson
Dovetail Training Limited Tel 01628 784906 Email [email protected]
Senior Forum & Postgraduate Qualifications Gill Lawrence
Kendle Tel 01344 751537 Fax 01344 751549
Website Carly Baker
AstraZeneca Tel 01625 582828 Fax 01625 583074
WORKING PARTIES
Clinical Research Computer System Validation Jane Tucker
GSK
Tel 020 8966 3658 Fax 020 8966 5339
SPECIAL INTEREST GROUPS
Coding & Dictionaries Ian Slack
Parexel
Tel 01895 614198 Fax 01895 614451
Electronic Data Richard Young
CMed Research
Tel 01403 755081 Fax 01403 755051
Laboratory Data Sam Singh
Pivotal Laboratories
Tel 01904 699405 Fax 01904 699401
Project Management in Data Management Andrew Green
Pfizer
Tel 01304 642242 Fax 01304 652218