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 ?
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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,