Re: Database Lock vs Database Freeze

We, someone, perhaps Bob should make a "list" of the vast array of
terms used by clinical trials data analysts to describe the same
object/event/etc. My favorite is the "Clinical Reporting Analysis
Plan".

It might make an interesting PharmaSUGI paper.

On 4/24/07, Bob_Abelson@hgsi.com <Bob_Abelson@hgsi.com> wrote:
> And just to add to the confusion, what Nancy said about database freeze
> vs. database lock has the meaning reversed in my company. Maybe it's
> because we use Clintrial instead of Oracle Clinical.
>
> Bob Abelson
> HGSI
> 240 314 4400 x1374
> bob_abelson@hgsi.com
>
>
>
> "Nancy Brucken" <brucken@PROVIDE.NET>
> Sent by: "SAS(r) Discussion" <SAS-L@LISTSERV.UGA.EDU>
> 04/24/2007 02:05 AM
> Please respond to
> "Nancy Brucken" <brucken@PROVIDE.NET>
>
>
> To
> SAS-L@LISTSERV.UGA.EDU
> cc
>
> Subject
> Re: Database Lock vs Database Freeze
>
>
>
>
>
>
> Hi Madan,
>
> To build on what Jim has said, these terms describe two different states
> of
> a clinical databases.
>
> The definitions differ somewhat between companies, but in general, a
> locked
> database is one where all queries have been resolved, meds and AEs have
> been coded, and the data is pretty clean. Locked databases can be updated
> as a result of data anomalies and inconsistencies found during the
> subsequent table review.
>
> Frozen databases are just that. The data has been frozen, and further
> updates will not be made, except in extreme cases, which require much more
> paperwork than updates to a locked database.
>
> Oracle Clinical has a specific set of steps for locking, and then
> freezing,
> a clinical study database, for example.
>
> Hope this helps,
> Nancy
>
> Nancy Brucken
> brucken@provide.net
>
> On Mon, 23 Apr 2007 03:56:00 -0400, Jim Groeneveld <jim2stat@YAHOO.CO.UK>
> wrote:
>
> >Well Madan,
> >
> >Gerhard already gave you two possible meanings of both terms, which I
> think
> >may be associated with either term. I would like to add a third meaning
> that
> >could be expressed by either term as well. In this meaning it would imply
> >that the database building process has been declared finished, stopped,
> >whether or not new data are still coming in. The data that are already in
> >the database have been _cleaned_ and _unblinded_. The database is frozen,
> >locked. It may have been made physically impossible to add or change
> >anything or it only has the status of a final db. This state of the db
> will
> >be used for statistical analysis (in pharmaceutical research). Sometimes
> a
> >database may be reopened if it yet shows too many inconsistencies or
> other
> >problems. But those terms indicate a final and reliable state of a db.
> >
> >Regards - Jim.
> >--
> >Jim Groeneveld, Netherlands
> >Statistician, SAS consultant
> >home.hccnet.nl/jim.groeneveld
> >
> >
> >On Mon, 23 Apr 2007 08:00:48 +0100, Madan Kundu <madan4331@YAHOO.CO.IN>
> wrote:
> >
> >>Hi ALL
> >>
> >> I have come across two terms �Database Lock� and �Database
> Freeze�. I am
> >not sure how does these two terms differ in their meaning. I will
> appreciate
> >if anybody helps me out.
> >>
> >> Thanks in advance.
> >>
> >> Regards
> >>
> >> Madan Gopal Kundu
> >> Biostatistician I, i3statprobe
> >> Tel(O): +91 (0) 124 3094 022, Mobile: +919868788406
> >>
> >>
> >>---------------------------------
> >> Check out what you're missing if you're not on Yahoo! Messenger
>