Post on 06-May-2015
description
I’d like to show you exactly how to manage clean data management
that builds a Bright Clinical Data Management Service from day 1 on
So you can perform with ease
beyond goals and expectaAons with a smile J!
My name is Maritza WiEeveen, former staAsAcal programmer,
data manager and head data management
More than a decade ago I sat 6 weeks at home,
worn out, unable to keep up;
at work, at home, at everything
Today I am a business-‐ and ‘estate-‐under-‐
construcAon’ owner, mothering a quartet and yes, quite relaxed
And no, I didn’t change my husbandJ!
How did I get there?
By learning to BE up-‐to-‐date
A do-‐abe skill I’d love to pass through
So, when you’ve been confronted with
unexpected, incomplete or inconsistent data OR you have concerns about your trial data processing,
please keep listening
Why is BEing up-‐to-‐date important for your clinical trial data?
BEing up-‐to-‐date is important because
SPEED is the first thing you need to be able to guarantee
quality data
Speed as in “feedback on any new or modified data
as soon as possible”
Enabling you to speak to the memory of the person who provided the data
Part of the truth otherwise fades…
What exactly WAS with this person
at the study site?
But aren’t we up-‐to-‐date already?
eCRFs and EDC systems made it tremendously
easier to BE up-‐to-‐date!
But are WE?
Do we send 2-‐minute-‐review-‐responses OR
do we send bulk replies?
Do we send our team members, study sites included, acAons OR projects?
Are WE fast in providing feedback on new or modified data?
What prevents us most from responding fast?
Thinking bulk work works best
Which is not
By sending bulk, you’ve made a project of the easy do-‐able,
quick acAons they were
On the contrary, sending bulk
results in procasAnaAon and longer lag Ames
So, how to BEcome up-‐to-‐date?
Up-‐to-‐date on data cleaning?
By reviewing any new or modified data since the last workday, FIRST
Reviewing any new or modified data in eCRFs
and data lisAngs
First thing, each workday morning
A do-‐able success, for the overall goal of CDM: delivering clean,
quality data
A]er that 5 to 30 minutes max., reduce lags, respond to requests, set-‐up new studies; build a bright
CDM service!
You can, now you are up-‐to-‐date!
I know you can BE up-‐to-‐date
But I also know you can adopt this new (team) rouAne with much more
ease and joy
By giving yourself and your team a Very Important
Team Day
On clean data management
that builds a Bright Clinical Data Management
Service
In which I give you my full aEenAon, leading you to
easy do-‐able results, enjoyed from day 1 on
For which VIT day you can apply below
What’s more to win when BEing up-‐to-‐date?
A posiAve, alive and kicking study, on site as well as in the office!
Future problems you won’t experience
Data CONTENT beyond capturing
clinical data
What results will you win from BEing up-‐to-‐date?
PosiAve conflicts between clinical trial team
members for beEer results
PosiAve rumour; the clinical trial is all
around and pleasantly visible
Shorter To-‐Do-‐lists
Team members advancing personally and professionally from each other
Your facts?
Just experiment BEing up-‐to-‐date
for 6 weeks
Measure pre-‐ and post response Ames
Measure total data verificaAon Ame for an ongoing study IN
the experiment, as compared to
a look-‐a-‐like study finished BEFORE the experiment
How to kick-‐off, as a team, enjoy BEing up-‐to-‐date?
By applying for a VIT day
“Time to Build a Bright Clinical Data Management
Service”
Shortcukng the though and long way,
to do clean data management
for a Bright Clinical Data Management
Service
Learning a (team) rouAne that will get you ready and
able to deliver clean data management,
every workday
My full aEenAon, leading you to
easy do-‐able results you will enjoy from day 1 on
Individually and as a team
You will learn to love doing the up-‐to-‐date skill!
So you can build your Bright Clinical Data Management Service
Your first easy acAon; apply for a VIT day
below
Thanks a lot for your aEenAon
Hearmelt regards,
Maritza