s Sneha
on

 

Hi,

I've two versions of the protocols in my study where one of new the inclusion criteria was deleted in the last version of protocol. All other Inclusion criteria were exactly same in the last protocol only order is getting changed because of this deletion.

Here I will explain using an example.

IETEST   IETESTCD  TIVERS

Abc         INCL01         1.0

def          INCL02          1.0

ghi          INCL03          1.0

 

IETEST   IETESTCD  TIVERS

Abc         INCL01         2.0

ghi          INCL03          2.0


So Paired variables will have one-one relationship now. But in my protocol version 2.0 there is only two inclusion criteria, and it is numberd as 1 and 2. Now sponsor want to maintain the same numbering in TESTCD also in TI domain as shown below

IETEST   IETESTCD  TIVERS

Abc         INCL01         2.0

ghi          INCL02          2.0

Now for one IETEST two IETESTCD will be there in the dataset. It will show issues while validation.. How to handle this issue ?

Any information would be appreciated.

Thanks,

Forums: SDTM

Want a demo?

Let’s Talk.

We're eager to share and ready to listen.

Cookie Policy

Pinnacle 21 uses cookies to make our site easier for you to use. By continuing to use this website, you agree to our use of cookies. For more info visit our Privacy Policy.