Date:         Wed, 24 Dec 2003 10:16:00 -0000
Reply-To:     Roland <roland@RASHLEIGH-BERRY.FSNET.CO.UK>
Sender:       "SAS(r) Discussion" <SAS-L@LISTSERV.UGA.EDU>
From:         Roland <roland@RASHLEIGH-BERRY.FSNET.CO.UK>
Organization: Universe Monitors
Subject:      Re: why 3 weeks from database release to final reports?

"Ed C" <references@ALEXANLLC.COM> wrote in message
news:200312240729.hBO7TSS04536@listserv.cc.uga.edu...
> On Wed, 24 Dec 2003 00:59:39 -0000, Roland <roland@RASHLEIGH-
> BERRY.FSNET.CO.UK> wrote:
>
> >Why do the pharmaceuticals pat themselves on the backs if it takes them 3
> >weeks from database release to final statistical reports? If these are
all
> >pre-defined reports from months back then why aren't they correct and
ready
> >to run in an instant? Why can't the reporting programs be so thoroughly
> >validated that they don't need a further QC? If it were telephone billing
> >then would the phone company be happy with a 3 week delay between meters
> >read and bills being sent out? Would they have QC people hand-calculating
> >hundreds of bills checking for errors and have meetings to discuss bill
> >detail layout? Methinks 3 weeks is 3 weeks too much.
> >
> >--
> >"Today's mighty oak is just yesterday's nut,
> >that held its ground." - David Icke
>
> Hi Roland,
>
> CT Reporting is iterative and not mechanical; anyway, there's nothing
wrong
> with the search for efficiency as long as it is applicable.  As the other
> responders have already mentioned, data about people brings its own
dynamic
> that is very hard to plan for.  Regulatory agencies also require that
> reporting be robust; it therefore takes a while to pin down exactly how
> information should be presented based on the necessary input from all
> parties involved (may include reg agency input as well).

Well, if by "database release" is meant the final form of the data, and the
reports report on that data and not some interpretation of it, then why can
it not be done straight away? If the data is the official record of the
trial (which it is) then why should it take time to report on that data,
whether inconsistencies are inherent in the data or not? If totlas to not
tally because of known inconsistencies that can not be resolved then this
could be mentioned in the text of the trial report. But if this 3 week gap
is there for people to realise that data inconsistencies exists when the
reports are scrutinised for the first time in close detail then would it not
have been better to put checks in place such that these inconsistencies were
spotted shortly after the data came in? Were these checks not defined or not
run? It strikes me that this 3 week gap is allowed there by management to
absorb a mix of possible problems, with management not having a grasp or
control of the situation, like they do not know how the time gets used up or
why and have given up trying to get it under control. If the delay is
caused, nearly always, by data issues then does this area need to be
tightened up with better and more timely checks? If it is programming errors
then does better and more timely validation need to be put in place?

> Thanks, and Happy Holidays All!

From me too. And a challenging New Year.

> Ed C
> Principal Consultant
> Alexan LLC
> http://www.alexanllc.com