AD0151 - help !

j James

on April 3, 2014

Hi,

I keep getting this warning when i run my checks, but i cant see any other way to do it.

In ADEG for example, I have PARAMCD=RRMEAN, HRMEAN etc...

Then i have several CRITx variables which are blank, or populated with CRIT1='QTcF > 450ms' or

CRIT2='QTcF increase from baseline > 30ms' for example.

Then I get the error because some are blank and some populated within a unique PARAMCD.

Can someone help! Or suggest another way to create these criteria variables.

James

Forums: ADaM

m Michael

on April 3, 2014

Please provide data :)

Could you paste your data example here (i pasted from excel to word, word to here with Input format as "full HTML)). or send it to me at mike@opencdisc.org

Also, what version of validator are you using ? Most of the later versions should only fail this rule when both PARAMCD and CRITy are NOT NULL. In the example below, i expect 2 records to fail which are highlighted

"All CRITy values must be the same for each unique value of PARAMCD when PARAMCD and CRITy are populated"

USUBJID	AVISITN	PARAM	PARAMCD	CRIT1	CRIT2	AVALC
10001	1	Migraine Pain	MIGRAINE	PAIN <= 1	PAIN <= 2	Mild Pain
10001	1	Migraine Pain	MIGRAINE	PAIN <= 1	PAIN <= 2	Mild Pain
20001	2	Migraine Pain	MIGRAINE	PAIN <= 1	PAIN <= 2	Mild Pain
10001	1	Migraine Pain	MIGRAINE	PAIN <= 1	PAIN <= 2	Moderate Pain
20001	2	Migraine Pain	MIGRAINE	BAD for CRIT1	PAIN <= 2	Moderate Pain
10001	1	Migraine Pain	MIGRAINE	PAIN <= 1	BAD for CRIT2	Severe Pain
20001	2	Migraine Pain	MIGRAINE	PAIN <= 1	PAIN <= 2	Severe Pain

30001	3	Ear Pain	EARPAIN	PAIN <= 1	PAIN <= 2	Mild Pain
30001	3	Ear Pain	EARPAIN	PAIN <= 1	PAIN <= 2	Mild Pain
30001	3	Ear Pain	EARPAIN	PAIN <= 1	PAIN <= 2	Mild Pain
30001	3	Ear Pain	EARPAIN	PAIN <= 1	PAIN <= 2	Mild Pain
30001	3	Ear Pain	EARPAIN	PAIN <= 1	PAIN <= 2	Moderate Pain
30001	3	Ear Pain	EARPAIN		PAIN <= 2	Severe Pain