[EpiData-list] Locking of a dataset in EpiData Entry

epidata-list at lists.umanitoba.ca epidata-list at lists.umanitoba.ca
Wed Nov 16 13:33:00 CST 2011


The simple answer is: No

The more subtle one is : Yes if you use the software appropriately

Currently EpiData Entry does not support a "locking" mechanism as such,  
but in practice what you can do is the following:

a. Enter and double enter your data
     save each of the two files
b. Verify against original materials/forms (CRF) and edit accordingly.
     save the new and edited correct file
     write proper data documentation and show to the monitors.
     Sign appropriate documents
c. Save in a secure server a copy of the verified file in a place where 
only other persons have access.
d. Now you have a secured copy which at any time can be verified against 
the "c" file.

Locking is just a terminology meaning that "at this point a copy of the 
data exists" which can be verified for changes.

In the new EntryClient and Datamanager we will implement a more "solid" 
principle for handling GCP auditing and logging of data, including what 
you refer to as a locked database. For more reading on principles of GCP 
see reference below:

Regards
Jens Lauritsen
EpiData Association
-------------
Standard requirements for GCP-compliant data management in multinational 
clinical trials

Christian Ohmann, Wolfagang Kuchinke, Steve Canham, Jens Lauritsen, 
Nader, Salas, Carmen Schade-Brittinger, Michael Wittenberg, Gladys 
McPherson, John McCourt, François Gueyffier, Andrea Lorimer, Ferran 
Torres, Ecrin Working Group on Data Centres

A recent survey has shown the data management in clinical trials 
performed by academic trials units still faces many difficulties (e.g. 
heterogeneity of software products, deficits in quality management, 
limited human and financial resources and the complexity of running a 
local computer center). Unfortunately, no specific, practical and open 
standard for both GCP-compliant data management and the underlying 
IT-infrastructure is available to improve the situation. For this reason 
the "Working Group on Data Centres" of the European Clinical Research 
Infrastructures Network (ECRIN) has developed a standard specifying the 
requirements for high quality GCP-compliant data management in 
multinational clinical trials.

Trials 2011, 12:85 (March 2011)

Article web link http://www.trialsjournal.com/content/12/1/85 
<http://www.trialsjournal.com/content/12/1/85>


On 2011-11-16 10:17, epidata-list at lists.umanitoba.ca wrote:
> Dear Epi-data I have looked through all possible help-files for 
> Epi-Data entry, but have not been able to find an answer. I am 
> therefore writing now. Is it possible to lock the dataset in EpiData 
> Entry, when entry has been finalized and the dataset is final? And 
> will epi-data log any changes made - if possible with eg a password - 
> if any are made after the data is locked? Thank you in advance for 
> your help. Kind Regards Anna Aabakke M.D. and Ph.D.-student Dep. 
> Gynaecology and Obstetrics University of Copenhagen, Holbæk Hospital 
> _______________________________________________ EpiData-list mailing 
> list EpiData-list at lists.umanitoba.ca 
> http://lists.umanitoba.ca/mailman/listinfo/epidata-list 



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