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How to change subject OID to the same number as Subject number

Hi Liz

We have the same restrictions as you have and have documented everything carefully and we have discussed this internally and decided to do what you do in cases like this, namely to handle this in DM programming. As long as we export data as tab delimited text, everything is fine, it is when we export the data as CDISC ODM XML 1.3 Full with OpenClinica extensions we run into problems and suddenly subject number 403 has disappeared and the old subject number 7703 shows up again.

We had hoped for a validated method of correcting this discrepancy as long as it would not violate 21 CFR part 11.

Best regards

Krister
Sent: Friday, May 10, 2013 8:23 PM
To: [email protected]
Subject: Re: [Users] How to change subject OID to the same number as Subject number

This might not be the answer you're hoping for, but we decided that monkeying with subject OID was pretty much a no-no here. In our case, back end data changes go against the processes we have in place that keep our data validated. Even if you aren't subject to 21 CFR Part 11, how much are you really allowed to change data at the back end?
Where we've had errors, we've either noted them and handled them in programming at the end of a study or re-entered the data and removed the incorrect subject number.

Liz Robertson
Director of Data Management and IT
TRACON Pharmaceuticals, Inc.
[email protected]
office: 858.550.0780 ext. 237
cell: 760.481.5527
Sent: Friday, May 10, 2013 11:04 AM
To: [email protected]
Subject: Re: [Users] How to change subject OID to the same number as Subject number
Hi Patrick,

You may be right but the manual talks about changing the OID SS_7703 but it does not work. I have full system access to the database but I prefer not to make any changes directly in PG.
Lets hope we get a solution from OpenClinica LLC

Best regards

Krister
Sent: Friday, May 10, 2013 6:27 PM
To: [email protected]
Subject: Re: [Users] How to change subject OID to the same number as Subject number

Hi Krister,

i've just begun to use OpenClinica but i think the only solution would be manipulating the SS_OID in the DB directly.
SS_OID is a DB Key, when u change it be sure to change all dependencies in other tables as well.

I have, right now, no access to the DB of our OC Installation. But i'll try later and will write further explanation if needed.
As we are using postgres pgAdmin is the tool to use. This implies, that you have the autorisation and access to the DB. If not you have to contact your sysadmin.

Maybe I'm totally wrong, so maybe another high experienced OC user can write some explanation to.

Regards

Patrick Werner
Master Student - Medical Informatics - University of Heilbronn & Heidelberg

Am 10.05.2013 um 11:33 schrieb "Krister Kristianson" :

Hi,

I need help to change the subject OID for one patient. The hospital staff by mistake entered 7703 instead of 403 for one of the patients. I was able to change the subject number but the SS_OID still shows SS_7703. I have looked in the manual but I can’t find instructions to actually change SS_OID!

Regards

Krister

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