SDTM

I'm getting error SD1079 for the MHEVDTYP variable using the 3.3 (FDA) community version of P21. 

The SDTM Model 2.0 lists the correct order as:  STUDYID, DOMAIN, USUBJID, MHSEQ, MHSPID, MHTERM, MHLLT, MHLLTCD, MHDECOD, MHEVDTYP, MHPTCD, MHHLT, MHHLTCD, MHHLGT, MHHLGTCD, MHCAT, MHBODSYS, MHBDSYCD, MHSOC, MHSOCCD, EPOCH,  MHSTDTC, MHENDTC, MHSTDY, MHENDY, MHENRTPT, MHENTPT.

But this is order is giving the SD1079 error.  Any suggestions?

Thank you

The planned dose frequency(BID) and actual dose frequency(QD) are different. How to represent this record in the EC domain? 

As per protocol , Eligibility criteria confirmation is done at V1 (screening) and at V2(Day1 of treatment epoch, before randomization.)

In case Eligibility criteria was all met at V1, but not met at V2 so that ends in Screening Failure, 

Can I assign epoch as 'SCREENING' to V2 while Randomized Patients are assigned as 'TREATMENT' at V2?

I mean, Doesn't  Visit and Epoch have to match 1:1?

Please help me to get assurance. 

When the Inclusion/Exclusion criteria do not change, but a new one is inserted in a subsequent version, the criteria number has been identified by adding a suffix to the IETESTCD.

TIVERS=Version 1

IETESTCD=EXCL01

IETEST=Ongoing infection

TIVERS=Version 2

IETESTCD=EXCL01A

IETEST=Patients with melanoma

IETESTCD=EXCL02A

IETEST=Ongoing infection

Pinnacle 21 however gives the following message for the EXCL02A record, since the same IETEST now has two different IETESTCD.

Hi there,

Is there a time schedule for when Pinnacle21 plans to support SDTM IG 3.3 validation under NMPA engine?

Thank you!

zg

When I use P21 to validate sdtm data, this message "DSDECOD value not found in 'Completion/Reason for Non-Completion' extensible codelist when DSCAT == 'DISPOSITION EVENT'" occurred, because there are some DSDECOD are not controlled terminology values. but when I validated again, this message didn't occur, I'm confused, for the same data, why this message occurred some times. Anyone know it? thanks!

Hi 

I have a study with 7different arms of treatment, that mean 7 DOSE differents but  DOSFRQ and DOSU are the same.

So I have created 7 rows for DOSE with TSSEQ 1 to 7. But my question is how can I express DOSFRQ and DOSU? Should I create 7 rows each ? Or one row each? 

Thank you.

Sunset

SD1078 occurs when all permissible variables are null, but no message is generated for --DY.
Is it because --DY can be null for all records when there is no RFSTDTC value?

I am trying to create an empty excel file with all metadata from P21. Can you please advise, how to do it?

Hi, 

In the cross over study, there are two treatments, 4 periods - So  populated ARMCD as A-B-A-B. Coming to ACTARMCD - the subject is not treated for any of the periods. Example : A-B-NOTTRT-B. In this case, ACTARMCD is not match with ARMCD and getting the SD2236, SD2237 messages in the Pinnacle validation report. Please suggest, shall we consider this as false positive or any alternate solution. Also, if the subject Not treated for two periods then ACTARMCD length exceeds 20 characters [A-NOTTRT-A-NOTTRT]. Do we need to restrict length as 20 for ACTARMCD?