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
>>
>>
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