Validation Rule Suggestions

Hello,

I'm getting the following Warnings reported for TS and I'm not sure why:

SD1038     Non-unique value for TSSEQ variable within TSPARMCD     Error     5
SE2201     Missing both AGE and AGETXT Trial Summary Parameters     Warning     1

My TSSEQ is always 1 and I don't have duplicates within TSPARMCD. And AGE is populated (along with AGEU).

Any idea? I can attach the TS file, if necessary.

Thanks!

Hello,

I'm getting the following "duplicate records" message for FW when POOLID is fed and USUBJID is empty:
FWTESTCD, FWDTC, USUBJID     FC, 2009-11-12T00:00:00, null     SD1117     Duplicate records

The records listed as duplicates by the above rule have the same FWTESTCD and FWDTC, and USUBJID is null because POOLID is fed (and with distinct values).
Shouldn't this rule be extended somehow so that, if USUBJID is null, to check for duplicates by the values of (FWTESTCD, FWDTC, POOLID)?
...

Hi,

I'm getitng some validation warnings I don't really understand, like:

CT0050 - Value for BGORRESU not found in (UNIT) CT codelist - for value "kg / day".

But my define.xml contains the entry for all 3 units used in BG.xpt (however just for kg / day CT0050 is trigerred).

And "CL.C71620.UNIT" is Extensible, so theoretically I have the right to add user-defined values to the CodeList.

Hello all,

I just used the 1.4.1 version to validate on sone studies and validate them for SEND.

I notices some inconsistencies with the SEND 3.0 standard:

#1. SE0063 - SEND/dataset variable label mismatch :

- Validator expects "Planned Study Day of Collection" as label for PC VISITDY, but in SEND specs this is "Visit Day".

- Validator expects "Date/Time of Reference Time Point" as label for PC PCRFTDTC, but in SEND specs it is "Date/Time of Reference Point". Same for PP PPRFTDTC.

Hello all,

SEND specs & examples suggest that CODY / CODTC should be fed usually for comments that are related to the study in general. And that CODY / CODTC are not necessary for comments related directly to domain records (since we already have the date information in the domain record's --DTC and --DY).

But when having in CO a comment row e.g. related to a MA record and without the CODY/CODTC info, one gets the SD0038 warning:

Hi, Could you add a rule to check dataset labels against Metadata for std domains and check if dataset labels are missing for sposor defined domains.

There will be no EX records for subjects who are randomized and not treated.  It would be useful if this validation rule would also check to see if ACTARMCD is 'NOTTRT' in addition to ARMCD being either 'SCRNFAIL' or 'NOTASSGN'.

Hi all,

I was wondering if such a rule is actually needed:

<val:Condition ID="SD1010" Test="ELEMENT == ''" When="ETCD == 'UNPLAN'" Message="ELEMENT value is populated, when ETCD= 'UNPLAN'" Description="Description of Element (ELEMENT) should be NULL, when subject's experience for a particular period of time is represented as an unplanned Element, where Element Code (ETCD) is equal to 'UNPLAN'" Category="Consistency" Type="Warning"/>

For Version 1.4, we have new rules SD1080,1081, and 1082that check variable length and send out following messages (ERROR in case of SD1082).  "Variable length should be assigned based on actual stored data to avoid to minimize file size. Datasets should be resized to the maximum length used prior to splitting."

But is the resize really required regardless or dataset size? Should these messages be just informational or really error?

HI,